The principle of the Internal combustion

通信原理英文教材Communication PrinciplesIntroductionCommunication principles are the foundational concepts and theories that guide the transmission, reception, and understanding of information between individuals or systems. These principles form the basis for effective communication and are crucial in various fields, including technology, business, and interpersonal relationships. In this text, we will explore some of the fundamental communication principles and their applications.1. Sender and ReceiverCommunication involves at least two parties: the sender and the receiver. The sender is responsible for encoding and transmitting the message, while the receiver decodes and interprets it. Both parties play crucial roles in the communication process, as effective communication requires clear and concise encoding techniques from the sender and attentive listening skills from the receiver.2. MessageThe message represents the information being transmitted. It can be verbal, written, or non-verbal, such as body language or facial expressions. A well-formulated message is crucial for effective communication, as it ensures the intended meaning is accurately conveyed. Clear and concise messages are less prone to misinterpretation, facilitating understanding between parties.3. ChannelThe channel refers to the medium through which the message is transmitted. It can be physical, such as air for spoken communication, or digital, such as emails or text messages. The choice of channel depends on various factors, including the nature of the message, the sender and receiver's accessibility, and the urgency of communication.4. NoiseNoise in communication refers to any interference that disrupts the clarity and accuracy of the message. External noise, such as background sounds or distractions, can hinder effective communication. Internal noise, such as biases or preconceived notions, can also impede understanding. Minimizing noise is essential for effective communication, and strategies like active listening and using appropriate communication channels can help mitigate its impact.5. FeedbackFeedback is the response or reaction provided by the receiver to the sender's message. It enables the sender to assess the effectiveness of their communication and make necessary adjustments. Feedback can be verbal or non-verbal and plays a crucial role in ensuring mutual understanding between parties. ConclusionUnderstanding and applying communication principles are essential in various aspects of life. By considering factors such as sender and receiver, message, channel, noise, and feedback, individuals can enhance their communication skills and foster effective and meaningful interactions. Ongoing practice andcontinuous improvement in communication principles can lead to improved relationships, increased productivity, and better overall communication outcomes.。

Ⅰ翻译软件版与人力翻译版之哈姆雷特1) To be, or not to be; that is the question: Whether ’tis nobler in the mind to sufferThe slings and arrows of outrageous fortune,Or to take arms against a sea of troubles,And by opposing end them? To die; to sleep;电脑版：到是，或不到是；那是问题：是否’tis比较高贵的在思想中遭受暴虐的财富投石器和箭，或带对抗麻烦的海洋双臂，而且藉由反对结束他们？死；睡觉；人脑版：生存还是毁灭，这是个必答之问题：是否应默默忍受坎坷命运之无情打击，还是应与深如大海之无涯苦难奋然为敌，并将其克服。

此二抉择，究竟是哪个较崇高？2) Devoutly to be wish’d. To die, to sleep;To sleep; perchance to dream; ay, there’s the rub; For in that sleep of death what dreams may come When we have shuffled off this mortal coil,Must give us pause: there’s the respectThat makes calamity of so long life;For who would bear the whips and scorns of time, The oppressor’s wrong, the proud man’s contumely, The p angs of despised love, the law’s delay,The insolence of office and the spurnsThat patient merit of the unworthy takes,When he himself might his quietus makeWith a bare bodkin? Who would fardels bear,To grunt and sweat under a weary life,But that the dread of something after death,The undiscover’d country from whose bournAnd makes us rather bear those ills we haveThan fly to others that we know not of?电脑版：虔诚的是wish’d。

Theprinciplesofeconomics. 经济学的原理（英译中）The word economy es from the Greek word for “one who manages a household. ” at first, this origin might seem peculiar.经济这个字眼来自希腊语中“家庭的管理者”，一开始，这个起源似乎看上去有些特殊。

But, in fact, households and economies have much in mon.但是，实际上，家庭和经济有许多的共同之处。

A household faces many decisions.一个家庭面临很多的决定。

It must decide which membersof the household do which tasks and what each member gets in return:它必须要决定家庭成员要完成任务，并且将每个家庭中的成员都安排在内。

Who cooks dinner?谁烧正餐？Who does the laundry?谁做洗衣服？Who gets the extra dessert at dinner?谁可以得到额外的餐后甜点？Who gets to choose what TV show to watch?谁可以选择电视节目来看？In short, the household must allocate its scarce resources among its various members, taking into account each member ' s abilitie s, efforts, and desires.总之，家庭必须把其缺乏的资源分配给其中的各种成员，并把每个成员能力，努力和愿望考虑进去，Like a household, a society faces many decisions.和家庭一样，社会也面临很多的决定。

a r X i v :c o n d -m a t /0606457v 2 [c o n d -m a t .m e s -h a l l ] 19 A p r 2007EPJ manuscript No.(will be inserted by the editor)Coulomb repulsion effects in driven electron transportFranz J.Kaiser,Peter H¨a nggi,and Sigmund KohlerInstitut f¨u r Physik,Universit¨a t Augsburg,Universit¨a tsstraße 1,D-86135Augsburg,Germany19April 2007Abstract.We study numerically the influence of strong Coulomb repulsion on the current through molec-ular wires that are driven by external electromagnetic fields.The molecule is described by a tight-bindingmodel whose first and last site is coupled to a respective lead.The leads are eliminated within a pertur-bation theory yielding a master equation for the wire.The decomposition into a Floquet basis enables an efficient treatment of the driving field.For the electronic excitations in bridged molecular wires,we find that strong Coulomb repulsion significantly sharpens resonance peaks which broaden again with increasing temperature.By contrast,it has only a small influence on effects like non-adiabatic electron pumping and coherent current suppression.PACS.05.60.Gg Quantum transport –85.65.+h Molecular electronic devices –72.40.+w Photoconduction and photovoltaic effects –73.63.-b Electronic transport in mesoscopic or nanoscale materials and structures1IntroductionRecent experiments on the conductance of single organic molecules opened a new direction in mesoscopic trans-port [1–3].Of particular interest is thereby the influence of electronic and vibronic excitations of the molecules which leave their fingerprints in the resulting current-voltage characteristics.At low temperatures,these effects become more pronounced [4].Much of our knowledge about excita-tions of molecules is based on spectroscopy,i.e.the optical response to light.In the context of molecular conduction,it has been proposed to study as well the signatures of such excitations in the transport quantifiers like the cur-rent [5–7]and its fluctuations [8].Such experiments are at present attempted,but clearcut evidence for the proposed effects is still missing because the irradiation also causes unwanted thermal effects in the contacts,which in today’s setups seem to dominate.One possibility to protect the contacts against the radiation is using the evanescent light at the tip of a near-field optical microscope.Coupled quantum dots represent a setup with proper-ties similar to those of molecular wires [9,10],albeit at dif-ferent length and energy scales.As compared to molecular wires,they are more stable and tunable,but have the dis-advantage that only a few dots can be coupled coherently.The transport properties of these “artificial molecules”can be significantly modified by microwaves [10].It has for example been demonstrated experimentally that res-onant excitations between the levels of double quantum dots result in the so-called photon-assisted transport,i.e.a significant enhancement of the dc current [11,12].In addition to photon-assisted transport [13],other less intuitive phenomena have been predicted in this context.For example the so-called coherent suppression of tun-nelling in a double-well potential due to a time-dependent dipole force can also be found in ac driven transport through coupled quantum dots:For characteristic ratios between the amplitude and the frequency of the driving,it has been predicted that the dc current [14–16]and the shot noise [17]will be suppressed.A further prominent effect is adiabatic electron pumping,which is the generation of a dc current by means of a periodic variation of the con-ductor parameters in the absence of any net bias [18–21].It has been proposed [22,23]and experimentally demon-strated [10,11]that pumping is more effective at internal resonances,i.e.,beyond the adiabatic limit where,in addi-tion,the pump current possesses a surprisingly low noise level [24].Periodically time-dependent quantum systems can be described very efficiently within a Floquet theory which originally has been derived for driven closed quantum sys-tems [25]and later been generalised to dissipative quan-tum systems [26,27].Furthermore,it is possible to derive Floquet theories for the description of transport through mesoscopic conductors which are connected to external leads.For cases in which electron-electron interactions do not play any role,one can derive a Floquet scatter-ing theory that provides exact expressions for the cur-rent [17,28]and its noise [8,17].Treating the coupling between the conductor and the leads perturbatively,one can obtain a master equation for the reduced density oper-ator of the wire.This enables a rather efficient treatment of time-dependent transport after decomposing the wire density operator into a Floquet basis.Then it is possi-ble to study relatively large driven conductors [29]and to include also electron-electron [30]and electron-phonon interactions [31].If the time-dependent field consists of2Franz J.Kaiser et al.:Coulomb repulsion effects in driven electron transportFig. 1.Bridged molecular wire model consisting of N=5sites with internal tunnelling matrix elements∆and effectivewire-lead coupling strengthsΓL/R.one or a few laser pulses,it is possible to obtain the den-sity operator by propagating the Liouville-von Neumannequation[32].In this work,we derive in Sections2and3a Flo-quet master equation formalism that captures situationsin which strong Coulomb repulsion restricts the excesscharge residing on the conductor to a single electron.Forlater reference,we adapt in Section4our approach tothe case of spinless electrons and non-interacting elec-trons.We then investigate in Section5the role of strongCoulomb repulsion for photon-assisted transport throughbridged molecular wires,non-adiabatic electron pumping,and coherent current suppression.2The wire-lead modelThe system of the driven wire,the leads,and the couplingbetween the molecule and the leads,as sketched in Fig.1,is described by the HamiltonianH(t)=H wire(t)+H leads+H wire-leads.(1)The wire is modelled within a tight-binding description bythe molecular orbitals|n ,n=1,...,N,so thatH wire(t)= n,n′,s H nn′(t)c†ns c n′s+U[H wire(t)+H leads,ρ(t)](8)1−Franz J.Kaiser et al.:Coulomb repulsion effects in driven electron transport3 Here thefirst term corresponds to the coherent dynam-ics of both the wire electrons and the lead electrons,whilethe second term describes resonant electron tunnelling be-tween the leads and the wire.The tilde denotes operatorsin the interaction picture with respect to the molecule andthe lead Hamiltonian without the molecule-lead coupling,X(t,t′)=U†0(t,t′)X U0(t,t′),where U0is the propagatorwithout the coupling.The net(incoming minus outgoing)electrical current through the left contact is given by mi-nus the time-derivative of the electron number in the leftlead multiplied by the electron charge−e.From Eq.(8)follows for the current in the wide-band limit the expres-sionI L(t)=e tr[˙ρ(t)N L]=−e ΓLd t |ϕα(t) =ǫα|ϕα(t) ,(12)whose solution allows one to construct via Slater deter-minants many-particle Floquet states.In analogy to thequasimomenta in Bloch theory for spatially periodic po-tentials,the quasienergiesǫαcome in classesǫα,k=ǫα+k Ω,k∈Z,(13)of which all members represent the same physical solutionof the Schr¨o dinger equation.Thus we can restrict ourselvesto states within one Brillouin zone like for example0≤ǫα< Ω.For the computation of the current it is convenient tohave an explicit expression for the interaction picture rep-resentation of the wire operators.It can be obtained fromthe(fermionic)Floquet creation and annihilation opera-tors[36]defined via the transformationcαs(t)= n ϕα(t)|n c ns.(14)The inverse transformationc ns= α n|ϕα(t) cαs(t)(15)follows from the mutual orthogonality and the complete-ness of the Floquet states at equal times[27].Note thatthe right-hand side of Eq.(15)becomes time independentafter the summation.The Floquet annihilation operator(14)has the inter-action picture representation˜cαs(t,t′)=U†0(t,t′)cαs(t)U0(t,t′)(16)=e−i(ǫα+UN wire)(t−t′)/ cαs(t′),(17)with the important feature that the time difference t−t′enters only via the exponential prefactor.This will allowus to evaluate theτ-integration of the master equation(8)after a Floquet decomposition.Relation(17)can easily beshown by computing the time derivative with respect to twhich by use of the Floquet equation(12)becomesd(ǫα+UN wire)˜cαs(t,t′).(18)Together with the initial condition˜cα(t′,t′)=cα(t′)fol-lows relation(17).Note that the time evolution inducedby H wire(t)conserves the number of electrons on the wire.3.2.2Master equation and current formulaIn order to make use of the Floquet ansatz,we decomposethe master equation(8)and the current formula(9)intothe Floquet basis derived in the last subsection.For that4Franz J.Kaiser et al.:Coulomb repulsion effects in driven electron transport purpose we use the fact that we arefinally interested inthe current at asymptotically large times in the limit of alarge interaction U.The latter has the consequence thatonly wire states with at most one excess electron play arole,so that the density operatorρwire can be decomposedinto the2N+1dimensional basis{|0 ,c†αs(t)|0 },where|0 denotes the wire state in the absence of excess electronsand s=↑,↓.Moreover,it can be shown that at large times,the density operator of the wire becomes diagonal in theelectron number N wire.Therefore a proper ansatz readsρwire(t)=|0 ρ00(t) 0|+ α,β,s,s′c†αs|0 ραs,βs′(t) 0|cβs′.(19)Note that we keep terms withα=β,which means that wework beyond a rotating-wave approximation.Indeed in anon-equilibrium situation,the off-diagonal density matrixelementsραβwill not vanish and neglecting them mightlead to artefacts[8,37].In the context of molecular wires,such a treatment of strong Coulomb repulsion by a re-striction to at most one excess electron has recently alsobeen applied to incoherent[38–40]as well as to coherenttransport[41].By inserting the decomposition(19)into the masterequation(8),we obtain an equation of motion for the ma-trix elementsραs,βs′= 0|cαsρwire c†βs′|0 .We evaluate thetrace over the lead states and compute the matrix element0|cαs(t)...c†βs′(t)|0 .Thereby we neglect the two-particleterms which are of the structure c†αs c†βs |0 0|cβs cαs.For-mally,these terms drop out in the limit of strong Cou-lomb repulsion because they are accompanied by a rapidly oscillating phase factor exp(−i UN wireτ/ ).Then theτ-integration results in a factor f L(ǫα,k+U)which vanishes in the limit of large U.Since the total Hamiltonian(1)is diagonal in the spin index s,wefind that the density ma-trix elementsραs,βs′are spin-independent as well so that after a transient stageρα↑,β↑(t)=ρα↓,β↓(t)≡ραβ(t)(20)andρα↑,β↓=0.Moreover,at large times,the density op-erator(19)will acquire the time periodicity of the driving field[8]and,thus,can be decomposed into the Fourier seriesραβ(t)= k e−i kΩtραβ,k(21)andρ00(t)accordingly.After some algebra,we arrive at a set of N2coupled equations of motion forραβ(t)which in Fourier represen-tation readi(ǫα−ǫβ−k Ω)ραβ,k=ΓL2 α′,k′,k′′ ϕα,k′+k′′|1 1|ϕα′,k+k′′ ρα′β,k′¯f L(ǫα′,k+k′′)−ΓLRe α,k β,k′ ϕβ,k′+k|1 1|ϕα,k ραβ,k′¯f L(ǫα,k)− k′ ϕα,k′+k|1 1|ϕα,k ρ00,k′f L(ǫα,k) .(24) Physically,the second contribution of the current formula (24)describes the tunnelling of an electron from the left lead to the wire and,thus,is proportional toρ00f L which denotes the probability that a lead state is occupied while the wire is empty.Thefirst terms corresponds to the re-versed process namely the tunnelling on an electron from site|1 to the left lead.The results of this section allow us the numerical com-putation of the dc current through a driven conductor in the the following way:First,we solve the quasienergy equation(12)which provides the coefficients ϕα,k|n .Next, we solve the master equation(22)and insert the solution into the current formula(24).4Separating interaction and spinIn order to determine the role of a strong interaction, we shall compare below our results to the non-interacting case.Moreover,a particular consequence of strong Cou-lomb repulsion is the mutual blocking of different spin channels.This motivates us to also compare to the case of spinless electrons which is physically realised by spin po-larisation.In this section,we adapt our master equation approach to these situations.Franz J.Kaiser et al.:Coulomb repulsion effects in driven electron transport5 4.1Spinless electronsIn order to describe spinless electrons,we drop in the ini-tial Hamiltonian all spin indices.Physically,this limit isrealised by a sufficiently strong magneticfield that po-larises all electrons contributing to the transport.By thesame calculation as in Section3,we then obtain for thecurrent also the expression(24)but without the prefactor2.The factor2is also no longer present in the normalisa-tion condition(23)which now readstrρwire(t)=ρ00(t)+ αραα(t)=1.(25)4.2Non-interacting electronsIn the absence of interactions,U=0,each spin degree offreedom can be treated separately.Still one has to considerfor each spin projection up to N electrons so that therelevant Hilbert space has the dimension2N.Therefore,it is more efficient to consider the single-particle densitymatrixRαβ(t)= c†αs(t)cβs(t) t=R∗βα(t)= k e−i kΩt Rαβ,k,(26)which is of dimension N2and nevertheless contains allrelevant information.The Fourier decomposition in thelast expression uses the fact that,at asymptotically largetimes,Rαβ(t)becomes time-periodic.We express the time derivative of Rαβ(t)with the mas-ter equation(8)and insert for˜cα(t,t−τ)the Floquetrepresentation(18).After some algebra,we obtain for theFourier coefficients Rαβ,k the equationi(ǫα−ǫβ+k Ω)Rαβ,k=ΓLα,k Reβ,k′ϕβ,k′+k|1 1|ϕα,k Rαβ,k′−| 1|ϕα,k |2f L(ǫα,k) .(28)For a detailed derivation see Ref.[36].5Interplay of dipole radiation and CoulombrepulsionIn our model Hamiltonian(1)we have already specifiedthe interaction,the lead Hamiltonian,and the wire-leadcoupling.By contrast,for the Hamiltonian of the drivenwire,we have thus far only assumed that the externalfieldis periodic in time.In the following we focus on modelswhere the single-particle dynamics is determined by theN-site tight-binding HamiltonianH nn′(t)=−∆N−1n=1(|n n+1|+|n+1 n|)+Nn=1{E n+Ax n cos(Ωt)}|n n|.(29)Neighbouring sites are coupled by a tunnel matrix element∆.The onsite energies E n are modulated by a harmon-ically time-dependent dipole force,where the amplitudeA is given by the electricalfield amplitude multiplied bythe electron charge and the distance between neighbour-ing sites.x n=16Franz J.Kaiser et al.:Coulomb repulsion effects in driven electron transportU =∞spinless00.10.2I [10−3e Γ/¯h ]89101112Ω[∆/¯h ]∞U =,spinless U =0,Fig.2.Photon-assisted current in a bridged molecular wirewith length N =8and height E B =10∆.Leads with a chemi-cal potential difference eV =5∆couple to the wire with an ef-fective strength Γ=0.1∆.The driving amplitude is A =0.3∆.For U =∞,the current for spinless electrons coincides with the one for real electrons.a factor 2.The electron dynamics within the wire,how-ever,is described by the coherent first term of the master equation (8)which is spin-independent.Consequently,we expect that the spin only plays a minor role whenever the tunnelling from the donor to the acceptor becomes the bottleneck for the electrons.This is indeed the case for the transport across a barrier considered here.As compared to the non-interacting case,one notices that strong Coulomb repulsion modifies the shape of the peaks:They become slightly higher and much sharper.This effect is more pronounced for large wires.A closer look at the resonance peaks for wires with up to N =10sites (not shown)indicates that the resonance widths scale roughly like 1/N .This is possibly caused by the fact that the Coulomb repulsion reduces the number of available (many-particle)wire states and,thus,the number of decay channels.This relates to the observation made in Ref.[41],namely that Coulomb repulsion can improve quantum co-herence and thereby enhance the current.Since quantum coherence is also temperature depen-dent,it is natural to ask whether the resonance peaks become sharper for lower temperatures.Figure 3shows the width of the central peak of Fig.2as a function of the temperature.While in the non-interacting case,the peak widths are essentially temperature independent,the sit-uation changes for strong Coulomb repulsion:There one finds that with an increasing temperature,the peaks be-come roughly twice as broad once the temperature exceeds T =∆/k B .We attribute this behaviour to the reduced coherence for thermal energies that are larger than the tunnelling matrix element.5.2Non-adiabatic electron pumpingAnother well studied phenomenon in driven transport is coherent electron pumping,i.e.,the creation of a non-vanishing dc current by ac fields in the absence of any net bias.For adiabatically slow driving,this effect exists onlyU =∞U =0,spinless00.050.10.15F W H M [∆/¯h ]0.0010.010.1110100T [∆/k B ]Fig.3.Temperature dependence of the widths of the reso-nance peaks at Ω≈9.71∆/ .The graph shows the full widths at half of the maximum.All other parameters are as in Fig.2.For U =∞,the values for spinless electrons and real electrons coincide.Fig.4.Tight-binding model for two coupled quantum dots in pump configuration,i.e.in the absence of a bias voltage but with an internal bias E 2−E 1=0which breaks reflection symmetry.in the absence of time-reversal symmetry [18–20].Beyond the adiabatic regime,this is no longer the case:For fast,time-periodic driving fields,it can be shown that the rele-vant symmetry is the so-called generalized parity which is defined as the invariance under spatial reflection in com-bination with a time shift by half a driving period [8].Non-adiabatic electron pumping is particularly interesting because at internal resonances of the central system the pump current can assume rather large values [10,22,35],while at the same time the current noise is remarkably low [24].For studying the influence of strong Coulomb repulsion on non-adiabatic electron pumping,we consider the setup sketched in Fig.4.Of particular interest is the parameter regime with large internal bias and intermediate dot-lead coupling because in this regime,the current-to-noise ratio is most favourable [24].The currents obtained for the three considered approaches are shown in Fig.5.Again we find that the spin degree of freedom is not of major influence,which indicates that the transport is governed by internal excitations;cf.the discussion in the preceeding subsection.The influence of the Coulomb repulsion is a modifica-tion of the current peak height up to 5%.This means that interactions are here much less important than for photon-assisted transport:The reason for this is that for our pump configuration,one energy level lies below the Fermi energyFranz J.Kaiser et al.:Coulomb repulsion effects in driven electron transport 700.10.20.3I [e Γ/¯h ]1234567Ω[∆/¯h ]U =∞U =∞,spinless U =0,spinlessFig.5.Pump current for strong Coulomb repulsion and fornon-interacting electrons as a function of the frequency.The dot levels with energies E 1=−2.5∆and E 2=2.5∆are couple to the leads with strength Γ=0.3∆.The driving amplitude is A =3.7∆and the temperature k B T =0.005∆.while the other lies well above.Thus in equilibrium for a sufficiently small dot-lead coupling,the left site is occu-pied while the right site is empty,whatever the interaction strength.Thus,the double dot is populated with only one electron so that interactions become irrelevant.Unless the driving amplitude is huge,this occupation is altered only slightly.Consequently interactions do not modify the cur-rent significantly.We emphasise that for strong dot-lead coupling Γand finite interaction U ,these arguments no longer hold true.5.3Coherent current controlAn intriguing example of quantum control is the so-called coherent destruction of tunnelling in a double-well po-tential by a suitable driving field [43],which can be ex-plained within a rotating-wave approximation:In the driv-ing dominated regime,the tunnel matrix element is es-sentially replaced by an effective tunnel matrix element ∆eff=J 0(A/ Ω),where J 0is the zeroth order Bessel function of the first kind and A the driving amplitude [44,45].Related effects have been predicted for driven tight-binding lattices [46].For driven transport between two leads,the corresponding situation has been investi-gated only recently:It has been found that driving fields that suppress tunnelling in a closed driven system,also suppress the current through the corresponding open sys-tem [14,47].A setup in which this coherent current suppression can be studied is sketched in Fig.6.It is characterized by the fact that all internal levels lie within the voltage window,i.e.below one chemical potential and above the other.For this system,strong interaction has already a significant influence on the current in the absence of any driving field [41]:For U =0,the system is half filled,which means it is populated by N/2electron,and the current is independent of N .By contrast for U =∞,the stationary population is N/(N +1)and the current becomes I ∝1/(N +1).Fig.6.Triple quantum dot configuration for coherent current control:A large bias voltage and the unbiased dot levels with E n =0ensure optimal transport in the absence of the driving.N =5N =300.20.40.6I [e Γ/¯h ]5101520253035A [∆]U =∞U =∞,spinless U =0,spinless00.20.40.6I [e Γ/¯h ]U =∞U =∞,spinless U =0,spinlessFig.7.Coherent current suppression as a function of the driv-ing amplitude A for a wire that consists of N =3sites.The applied voltage is eV =50∆,the driving frequency Ω=5∆,and the wire-lead coupling Γ=0.5∆.Figure 7shows the influence of Coulomb repulsion on the current suppression studied in Ref.[17].Independent of the interaction,one finds that the current almost van-ishes whenever the ratio A/ Ωmatches a zero of the Bessel function J 0.If the driving amplitude is far from the values for which the current is suppressed,we observe the behaviour found for the static situation,namely that Cou-lomb repulsion reduces the current by a factor 1/(N +1)for spinless electrons [41].If one considers the spin,this factor becomes 2/(2N +1).In the vicinity of the current suppressions,by contrast,the influence of both the inclu-sion of the spin and the interaction is less pronounced.In this regime,the effective tunnel matrix element ∆effis small,so that tunnelling along the wire happens at a low rate.This again indicates that whenever the transport is limited by the dynamics within the wire,the influence of interaction is rather small.8Franz J.Kaiser et al.:Coulomb repulsion effects in driven electron transport6ConclusionsWe studied the influence of strong interaction on the trans-port properties of ac-driven coherent conductors.In par-ticular,we compared the strongly interacting case with the opposite extreme of non-interacting electrons.Moreover, we worked out the relevance of the spin degree of free-dom for weak wire-lead coupling.In our studies,we con-sidered three archetypical effects,namely photon-assisted tunnelling through bridged molecular wires,non-adiabatic electron pumping,and coherent current suppression.The most significant effect is found for photon-assisted tunnelling where Coulomb repulsion renders the resonance linewidths much sharper.Thus unfortunately,interactions might contribute to the difficulties in photon-assited tun-nelling experiments with molecular wires.By contrast, Coulomb repulsion is not too relevant for electron pump-ing in double quantum dots.For coherent current suppres-sion,the same holds true only for parameters for which the current is already significantly reduced.Outside this region,onefinds that Coulomb repulsion reduces the cur-rent essentially in the same way as in the absence of driv-ing.The two extreme cases of zero and very strong interac-tion do not necessarily allow a simple interpolation.Thus, it is desireable to extend the present studies tofinite values of the interaction strength,which requires the generalisa-tion of our formalism to at least a second excess electron. 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《物流与供应链管理》(LOGISTICS AND SUPPLY CHAIN MANAGEMENT)Capsule summary of the book：The world changes unpredictably, which is dependent on the quick transformation of supply chain to adapt to the variational circumstances. This book focuses tightly on those variations mentioned above, emphasizing the problems that appear whenenterprises attach importance to complicated management, as well as whenforecast-driven business modeltransforms into demand-driven business model. Also, this book elaborates how to gives enterprises dominating and competitivesuperiority with effectivelogistics and supply chain management.Chapter1 Logistics, the supply chainand competitive strategy1.1Supply chain management is a wider concept than logisticsOne goal of supply chain managementmight be to reduce or eliminate the buffers of inventory that existbetween organizations in a chain through the sharing of information ondemand and current stock levels. This is the concept of ‘Co-ManagedInventory’ (CMI).The focus of supply chain management is upon the managementof relationships in order toachieve a more profitable outcome for allparties in the chain. This brings with it some significantchallengessince there may be occasions when the narrow self-interest of one partyhas to be subsumed for the benefit of the chain as a whole.1.2Competitive advantageAt itsmost elemental, commercial success derives from either a cost advantageor a value advantage or, ideally, both. It is as simple as that – themost profitable competitor in any industry sector tends to be the lowestcost producer or the supplier providing a product with the greatestperceiveddifferentiated values.A useful way of examining the available options is topresent them as a simple matrix.Value advantageCost advantageTo summarize, those organizations that will be the leaders in the marketsof the future will be those that have sought and achieved the twinpeaks of excellence: they have gained both cost leadership and serviceleadership.1.3 The supply chain becomes the value chainOrganizations shouldlook at each activity in their value chain and assess whether they have a real competitive advantage in the activity. If they do not, the argumentgoes, then perhapstheyshould consider outsourcing that activity to apartner who can provide that cost or value advantage.1.4The mission of logistics managementThe scope oflogistics spans the organization, fromthe management of raw materials through to the delivery of the finalproduct.The last decade has seen the rapid introduction of flexiblemanufacturing systems (FMS), of new approaches to inventory based onmaterials requirements planning (MRP) and just-in-time (JIT) methodsand, perhaps most important of all, a sustained emphasis on total qualitymanagement (TQM).1.5 The changing competitive environment●The new rules of competition●Globalization of industry●Downward pressure on price●Customers taking controlSummary:This chapter familiarizes the reader with the tenets of competitive strategyand within them the vectors of strategic direction: cost and valueadvantage.Vertically integrated businesses continue to be dismembered, refocusedand transformed into virtual ones held together not by ownership but by closely integrated core business processes and financial engineering.Instead of rivalry and mistrust within the supply chain, newcompetitive pressures are demanding speed and flexibility, which themselvesrequire greater openness and trust. In fact the ability to manageprocess innovation and integration are becoming as important capabilitiesas product innovation.Chapter2T Logistics and customervalue2.1 Delivering customer valueQuality × ServiceCustomer value = ––––––––––––––––Cost × TimeQuality: The functionality, performance and technical specificationof the offer.Service: The availability, support and commitment provided to thecustomer.Cost: The customer’s transaction costs including price and lifecycle costs.Time: The time taken to respond to customer requirements, e.g.delivery lead times.2.2 What is customer service?Customer service could be examinedunder three headings:1. Pre-transaction elementsWritten statements of service policy, Accessibility, Organization structure, System flexibility.2. Transaction elementsOrder cycle time, Inventory availability, Order fill rate, Order status information.3. Post-transaction elementsAvailability of spares, Call-out time, Product tracing/warranty, Customer complaints, claims, etc.2.3 The impact of out-of-stockIn the circumstance of out-of-stock, generally,31%Substitute same brand15%Delay purchase19%Substitute different brand26%Buy item at another store9%Do not purchase itemThe impact of logistics and customer service on marketingConsumerfranchise * Customerfranchise * Supply chainefficiency = Marketingeffectiveness•Brand values•Corporate image•Availability•Customer service•Partnership•Quick response•Flexibility•Reduced asset base•Low–cost supplier•Market share•Customer retention•Superior ROI2.4 Customer service and customer retentionThe importance of customer retention is underlined by the conceptof the ‘lifetime value’ of acustomer. The lifetime value of a customer iscalculated as follows:Lifetime value = Average transaction value× Yearly frequencyof purchase× Customer ‘lifeexpectancy’A prime objective of any customer service strategy should be to enhancecustomer retention.2.5Market-driven supply chainsNow, instead ofdesigning supply chains from the ‘factory outwards’ the challenge is todesign them from the ‘customer backwards’his new perspective sees the consumer not at the end of the supplychain but at its start. In effect this is the philosophical differencebetween supply chain management and what more properly might becalled ‘demand chain management’.1.IdentifyvaluesegmentsWhat do our customers value?2.Define thevaluepropositionHow do we translate theserequirements into an offer?3.Identifythe marketwinnersWhat does it take to succeedin this market?4.Develop thesupply chainstrategyHow do we deliver againstthis proposition?2.6Defining customer service objectivesThe whole purpose of supply chain management and logistics is to provide customers with the level and quality of service that they requireand to do so at less cost to the total supply chain. The perfect order is achievedwhen the customer’s service requirements are met in full.To calculate the actual service level usingthe perfect order concept requires performance on each element to bemonitored and then the percentage achievement on each element to bemultipliedtogether.2.7Setting customer service prioritiesQuadrant 1: Seek cost reductions2: Provide high availability3: Review4: Centralized inventory2.8Setting service standardssome of the key areaswhere standards are essential:Order cycle time Stock availability Order-size constraints Ordering convenience Frequency of delivery Delivery reliability Documentation quality Claims procedure Order completeness Technical support Order status informationthe following measures provide valuable indicators of performance：Pre-transactionStock availabilityTarget delivery dates Response times to queriesTransactionOrder fill rateOn-time deliverBack orders by ageShipment delaysProduct substitutionsPost-transactionFirst call fix rateCustomer complaintsReturns/claimsInvoice errorsService parts availabilitySummary:Ultimately all businesses compete through seeking to deliver superiorcustomer value and logistics processes provide the means by which customerservice is delivered.Logistics management can play a key role in enhancing customerlifetime value through increasing customer satisfaction and enhancedcustomer retention. To achieve this will require the development of amarket-driven logistics strategy and the redefinition of service objectivesbased upon customers’ specific requirements. ‘Perfect order’achievement should form the basis for the measurement of service performanceand the creation of service standard.Chapter3 Measuring logistics costs and performance3.1Logistics and the bottom lineProfitProfitSalesROI = ––––––––––––––––This ratio can be further expanded:ROI = –––––– × –––––––––––CapitalemployedSales Capital employedIt will be seen that ROI is the product of two ratios: the first,profit/sales, being commonly referred to as the margin and the second,sales/capital employed, termed capital turnover or asset turn. Thus togain improvement on ROI one or other, or both, of these ratios mustincrease. Typically many companies will focus their main attention onthe margin in their attempt to driveup ROI, yet it can often be moreeffective to use the leverage of improved capital turnover to boost ROI.3.2 Customer profitability analysisBuildDanger zoneCost engineerProtectChapter4 Creating the responsive supply chain4.1Product ‘push’ versus demand ‘pull’whilst independent demand may be forecast using traditional methods,dependent demand must be calculated, based upon the demand at thenext level in the logistics chain.4.2 The foundations of agilityBusiness process re-engineering (BPR) is the term frequently appliedto the activity of simplifying and reshaping the organizational processeswith the goal of achieving the desired outcomes in shorter time-framesat less cost. Many processes in the supply chain are lengthy because theconstituent activities are performed in ‘series’, i.e. in a linear, ‘one afterthe other’ way. It is often possible to re-engineer t he process so thatthose same activities can be performed ‘in parallel’, i.e. simultaneously.Postponement refers to the process by which the commitment of a productto its final form or location is delayed for as long as possible. Whendecisions on the final configuration or pack have to be made ahead ofdemand there is the inevitable risk that the products that are availableare not the ones the customer wants.The philosophy of postponement ideally would begin on the drawingboard so that products are designe d with late configuration inmind. The longer that products can remain as generic ‘work in progress’ then the more flexibility there will be to ensure the ‘rightproduct in the right place at the right time’.Chapter5 Strategic lead-time management5.1 The concept of lead timeFrom the customer’s viewpoint there is only one lead time: the elapsedtime from order to delivery. Clearly this is a crucial competitive variableas more and more markets become increasingly time competitive.Nevertheless it represents only a partial view of lead time. Just as important, from the supplier’s perspective, is the time it takes to convertan order into cash and, indeed, the total time that working capitalis committed from when materials are first procured through to whenth e customer’s payment is received.5.2 Logistics pipeline managementThe goals of logistics pipeline management are:●Lower costs●Higher quality●More flexibility●Faster response timesAn indicator of the efficiency of a supply chain is given by itsthroughput efficiency, which can be measured as:Value-addedtime*100End-to-end pipeline timeThroughput efficiency can be as low as 10 per cent, meaning that mosttime spent in a supply chain is non-value-adding time.5.3 The lead-time gapReducing logistics lead timeBottleneck managementImproving visibility of demandSummary:Time compression in the pipeline has the potential both to speed upresponse times and to reduce supply chain cost. The key to achievingthese dual goals is through focusing on the reduction of non-value-addingtime –and particularly time spent as inventory. Whereas in the past logisticssystems were very dependent upon a forecast, with all the problemsthat entailed, now the focal point has become lead-time reduction.Chapter6 The synchronous supply chain6.1 The role of information in the virtual supply chainFunctions of a logistics information system:Planning functionCo-ordination functionDatabaseCustomer servicecommunication functionControl function6.2 Implications for logisticsThe basic principle of synchronization is to ensure that all elements ofthe chain act as one and hence there must be early identification ofshipping and replenishment requirements and, most importantly of all,there must be the highest level of planning discipline.In a synchronous supply chain the management of in-bound materialsflow becomes a crucial issue.The idea of ‘stockless distribution centres’ or ‘cross-docking’enables a more frequent and efficient replenishment of product frommanufacture to individual stores.6.3 ‘Quick response’ logisticsWhat has made QR possible is thedevelopment of information technologyand in particular the rise ofInternet-enabled data exchange, bar coding, the use of electronic pointof sale (EPOS) systems with laser scanners and so on.Quick responseLess inventoryrequiredReducedlead timesLesspipelineinventoryLesssafety stockReducedforecastingerrorSummary:The key to supply chain responsiveness is synchronization.Synchronization implies that each entity in the network is closely connectedto the others and that they share the same information. In thepast there was often limited visibility, either upstream or downstream,meaning that organizations were forced to act independently, makingtheir own forecasts, and, as a result, i nevitably relying upon a ‘push’rather than a ‘pull’ philosophy.Chapter7 Managing the global pipeline7.1 The trend towards globalization in the supply chainFocused factoriesCentralization of inventoriesPostponement and localization7.2 Gaining visibility in the global pipelineSupply chain event management (SCEM) is the term given to theprocess of monitoring the planned sequence of activities along a supplychain and the subsequent reporting of any divergence from that plan.Ideally SCEM will also enable a proactive, even automatic, response to deviations from the plan.Chapter8 Managing risk in thesupply chain8.1 Why are supply chains more vulnerable?A focus on efficiency rather than effectivenessThe globalization of supply chainsFocused factories and centralized distributionThe trend to outsourcingReduction of the supplier base8.2 Understanding the supply chain risk profileSupply chain risk = Probability of disruption × ImpactThis audit shouldexamine potential risk to business disruptions arising from five sources: Supply riskDemand riskProcess riskControl riskEnvironmental risk8.3 Managing supply chain risk1.Understand the supply chain2.Improve the supply chain3.Identify the critical paths (nodes and links)4.Manage the critical paths5.Improve network visibility6.Establish a supply chain continuity team7.Work with suppliers and customers to improvesupply chain risk management proceduresSummary:All the evidence indicates that as markets become more volatile and thebusiness environment more turbulent, so supply chains become more vulnerableto disruption. Not all of the risk to supply chain continuity isexternal. Significant risk can be created as a result of management decisionsthat are taken on supply chain design and strategy.Chapter9 Overcoming the barriers tosupply chain integration9.1 Creating the logistics visionIdeally the logistics vision should be built around the simple issue of‘How do we intend to use logistics and supply chain management tocreate value for our customers?’The four elements of logistics-derived customer value highlightedpreviously are ‘Better, Faster, Cheaper, Closer’ and the criterion for agood logistics vision s tatement is that it should provide the roadmapfor how these four goals are to be achieved.9.2 Developing the logistics organizationThe horizontal organization has a number of distinguishing characteristics.It is:Organized around processesFlat and de-layeredBuilt upon multi-functional teamsGuided by performance metrics that are market-based9.3 BenchmarkingCompetitive benchmarking might simply be defined as the continuousmeasurement of the company’s products, services, processes andpractices against the standards of best competitors and other companieswho are recognized as leaders. The measures that are chosen forthe comparison must directly or indirectly impact upon customers’evaluation of the company’s performance.Identifying logistics performance indicatorsThe idea behind the balanced scorecard is thatthere are a number of key performance indicators –most of them probablynon-financial measures –that will provide management with abetter means of meeting strategic goals than the more traditional financiallyoriented measures.Step 1: Articulate logistics and supply chain strategy2: What are the measurable outcomes of success?3: What are the processes that impact these outcomes?4: What are the drivers of performance within these processes?In this framework the four key outcomes of success are suggested to be:Better, Faster, Cheaper, CloserSummary:internally integrated across functions and they are externally integratedwith upstream suppliers and downstream customers. Many companiesare impeded in their attempts to become more agile and responsivebecause of an entrenched functional structure. They manage functionsrather than processes and hence have a fragmented approach to themarketplace. It is also difficult for such firms to contemplate externalintegration when they lack internal integration.Chapter10Entering the era ofnetwork competition10.1 Seven major business transformationsFrom supplier-centric to customer-centricFrom push to pullFrom inventory to informationFrom transactions to relationshipsFrom ‘trucks and sheds’ to ‘end-to-end’ pipeline managementFrom functions to processesFrom stand-alone competition to network rivalry10.2 From 3PL to 4PL™Third-party logistics service providers are companies who provide arange of logistics activities for their clients. They might operate distributioncentres, manage the delivery of the product through theirtransport fleets or undertake value-adding services such as re-packing.The fourth-party logistics service provider was that because modern supply networksare increasingly global and certainly more complex, the capabilities tomanage the network probably do not exist in any one organization. Insuch situations, there is a need for an organization who can use itsknowledge of supply chains and specialist third-party service providersto manage and integrate the complete end-to-end supply chain.The 4PL™ would assemble a coalition of the ‘best of breed’ serviceproviders and – using its own information systems capability – ensure acost-effective and sustainable supply chain solution.Whether the 4PL™ be a joint venture or some other model there arefour key components that must be in place. These are:1. Systems architecture and integration skills2. A supply chain ‘control room’3. Ability to capture and utilize information and knowledge across the network4. Access to ‘best of breed’asset providers。

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH H ARMONISED T RIPARTITE G UIDELINEG OOD M ANUFACTURING P RACTICE G UIDE FORA CTIVE P HARMACEUTICAL I NGREDIENTSRecommended for Adoptionat Step 4 of the ICH Processon 10 November 2000by the ICH Steering CommitteeThis Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.G OOD M ANUFACTURING P RACTICE G UIDE FORA CTIVE P HARMACEUTICAL I NGREDIENTSICH Harmonised Tripartite GuidelineHaving reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 10 November 2000, this guideline is recommended foradoption to the three regulatory parties to ICHTABLE OF CONTENTS1. INTRODUCTION (1)1.1 Objective (1)1.2 Regulatory Applicability (1)1.3 Scope (1)2. QUALITY MANAGEMENT (4)2.1 Principles (4)2.2 Responsibilities of the Quality Unit(s) (4)2.3 Responsibility for Production Activities (5)2.4 Internal Audits (Self Inspection) (5)2.5 Product Quality Review (6)3. PERSONNEL (6)3.1 Personnel Qualifications (6)3.2 Personnel Hygiene (6)3.3 Consultants (7)4. BUILDINGS AND FACILITIES (7)4.1 Design and Construction (7)4.2 Utilities (8)4.3 Water (8)4.4 Containment (9)4.5 Lighting (9)4.6 Sewage and Refuse (9)4.7 Sanitation and Maintenance (9)5. PROCESS EQUIPMENT (9)5.1 Design and Construction (9)5.2 Equipment Maintenance and Cleaning (10)5.3 Calibration (11)5.4 Computerized Systems (11)Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients6. DOCUMENTATION AND RECORDS (12)6.1 Documentation System and Specifications (12)6.2 Equipment Cleaning and Use Record (13)6.3 Records of Raw Materials, Intermediates, API Labelling andPackaging Materials (13)6.4 Master Production Instructions(Master Production and Control Records) (13)6.5 Batch Production Records (Batch Production and Control Records).. 146.6 Laboratory Control Records (15)6.7 Batch Production Record Review (15)7. MATERIALS MANAGEMENT (16)7.1 General Controls (16)7.2 Receipt and Quarantine (16)7.3 Sampling and Testing of Incoming Production Materials (17)7.4 Storage (17)7.5 Re-evaluation (18)8. PRODUCTION AND IN-PROCESS CONTROLS (18)8.1 Production Operations (18)8.2 Time Limits (19)8.3 In-process Sampling and Controls (19)8.4 Blending Batches of Intermediates or APIs (19)8.5 Contamination Control (20)9. PACKAGING AND IDENTIFICATION LABELLING OF APIsAND INTERMEDIATES (20)9.1 General (20)9.2 Packaging Materials (21)9.3 Label Issuance and Control (21)9.4 Packaging and Labelling Operations (21)10. STORAGE AND DISTRIBUTION (22)10.1 Warehousing Procedures (22)10.2 Distribution Procedures (22)11. LABORATORY CONTROLS (23)11.1 General Controls (23)11.2 Testing of Intermediates and APIs (24)11.3 Validation of Analytical Procedures (24)11.4 Certificates of Analysis (24)Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients11.5 Stability Monitoring of APIs (25)11.6 Expiry and Retest Dating (25)11.7 Reserve/Retention Samples (25)12. VALIDATION (26)12.1 Validation Policy (26)12.2 Validation Documentation (26)12.3 Qualification (27)12.4 Approaches to Process Validation (27)12.5 Process Validation Program (28)12.6 Periodic Review of Validated Systems (28)12.7 Cleaning Validation (28)12.8 Validation of Analytical Methods (29)13. CHANGE CONTROL (29)14. REJECTION AND RE-USE OF MATERIALS (30)14.1 Rejection (30)14.2 Reprocessing (30)14.3 Reworking (31)14.4 Recovery of Materials and Solvents (31)14.5 Returns (31)15. COMPLAINTS AND RECALLS (32)16. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES). 3217. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS,AND RELABELLERS (33)17.1 Applicability (33)17.2 Traceability of Distributed APIs and Intermediates (33)17.3 Quality Management (33)17.4 Repackaging, Relabelling and Holding of APIs and Intermediates (33)17.5 Stability (34)17.6 Transfer of Information (34)17.7 Handling of Complaints and Recalls (34)17.8 Handling of Returns (34)18. SPECIFIC GUIDANCE FOR APIs MANUFACTURED BY CELLCULTURE/FERMENTATION (35)18.1 General (35)18.2 Cell Bank Maintenance and Recordkeeping (36)18.3 Cell Culture/Fermentation (36)Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients18.4 Harvesting, Isolation, and Purification (37)18.5 Viral Removal/Inactivation Steps (37)19. APIs FOR USE IN CLINICAL TRIALS (38)19.1 General (38)19.2 Quality (38)19.3 Equipment and Facilities (38)19.4 Control of Raw Materials (39)19.5 Production (39)19.6 Validation (39)19.7 Changes (39)19.8 Laboratory Controls (39)19.9 Documentation (39)20. GLOSSARY (40)G OOD M ANUFACTURING P RACTICE G UIDE FORA CTIVE P HARMACEUTICAL I NGREDIENTS1. INTRODUCTION1.1 ObjectiveThis document (Guide) is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess.In this Guide “manufacturing” is defined to include all operations of receipt of materials, production, packaging, repackaging, labelling, relabelling, quality control, release, storage and distribution of APIs and the related controls. In this Guide the term “should” indicates recommendations that are expected to apply unless shown to be inapplicable or replaced by an alternative demonstrated to provide at least an equivalent level of quality assurance. For the purposes of this Guide, the terms “current good manufacturing practices” and “good manufacturing practices” are equivalent.The Guide as a whole does not cover safety aspects for the personnel engaged in the manufacture, nor aspects of protection of the environment. These controls are inherent responsibilities of the manufacturer and are governed by national laws.This Guide is not intended to define registration/filing requirements or modify pharmacopoeial requirements. This Guide does not affect the ability of the responsible regulatory agency to establish specific registration/filing requirements regarding APIs within the context of marketing/manufacturing authorizations or drug applications. All commitments in registration/filing documents must be met.1.2 Regulatory ApplicabilityWithin the world community, materials may vary as to the legal classification as an API. When a material is classified as an API in the region or country in which it is manufactured or used in a drug product, it should be manufactured according to this Guide.1.3 ScopeThis Guide applies to the manufacture of APIs for use in human drug (medicinal) products. It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile. The sterilization and aseptic processing of sterile APIs are not covered by this guidance, but should be performed in accordance with GMP guidelines for drug (medicinal) products as defined by local authorities.This Guide covers APIs that are manufactured by chemical synthesis, extraction, cell culture/fermentation, by recovery from natural sources, or by any combination of these processes. Specific guidance for APIs manufactured by cell culture/fermentation is described in Section 18.Good Manufacturing Practice Guide for Active Pharmaceutical IngredientsThis Guide excludes all vaccines, whole cells, whole blood and plasma, blood and plasma derivatives (plasma fractionation), and gene therapy APIs. However, it does include APIs that are produced using blood or plasma as raw materials. Note that cell substrates (mammalian, plant, insect or microbial cells, tissue or animal sources including transgenic animals) and early process steps may be subject to GMP but are not covered by this Guide. In addition, the Guide does not apply to medical gases, bulk-packaged drug (medicinal) products, and manufacturing/control aspects specific to radiopharmaceuticals.Section 19 contains guidance that only applies to the manufacture of APIs used in the production of drug (medicinal) products specifically for clinical trials (investigational medicinal products).An “API Starting Material” is a raw material, intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. An API Starting Material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in-house. API Starting Materials normally have defined chemical properties and structure.The company should designate and document the rationale for the point at which production of the API begins. For synthetic processes, this is known as the point at which "API Starting Materials" are entered into the process. For other processes (e.g. fermentation, extraction, purification, etc), this rationale should be established on a case-by-case basis. Table 1 gives guidance on the point at which the API Starting Material is normally introduced into the process.From this point on, appropriate GMP as defined in this Guide should be applied to these intermediate and/or API manufacturing steps. This would include the validation of critical process steps determined to impact the quality of the API. However, it should be noted that the fact that a company chooses to validate a process step does not necessarily define that step as critical.The guidance in this document would normally be applied to the steps shown in gray in Table 1. It does not imply that all steps shown should be completed. The stringency of GMP in API manufacturing should increase as the process proceeds from early API steps to final steps, purification, and packaging. Physical processing of APIs, such as granulation, coating or physical manipulation of particle size (e.g. milling, micronizing), should be conducted at least to the standards of this Guide.This GMP Guide does not apply to steps prior to the introduction of the defined "API Starting Material".Good Manufacturing Practice Guide for Active Pharmaceutical IngredientsTable 1: Application of this Guide to API ManufacturingType ofManufacturingApplication of this Guide to steps (shown in grey) used in this type ofmanufacturing ChemicalManufacturing Production of the APIStartingMaterialIntroduction of the API Starting Material into process Production of Intermediate(s) Isolation and purification Physical processing, and packaging API derived from animal sources Collection oforgan, fluid, ortissue Cutting, mixing, and/or initialprocessingIntroduction of the API Starting Material into process Isolation and purification Physical processing, and packaging API extracted from plant sources Collection of plants Cutting andinitialextraction(s) Introduction of the API StartingMaterial intoprocessIsolation and purification Physical processing, and packaging Herbal extracts used as API Collection of plants Cutting and initial extraction Further extraction Physicalprocessing,andpackagingAPI consisting of comminuted or powdered herbs Collection of plants and/or cultivation and harvesting Cutting/ comminuting Physicalprocessing,andpackagingBiotechnology: fermentation/ cell culture Establishment of master cell bank and working cell bank Maintenance of working cell bank Cell culture and/or fermentation Isolation and purification Physicalprocessing,andpackaging“Classical” Fermentation to produce an API Establishment of cell bank Maintenance of the cell bank Introduction of the cells into fermentation Isolation and purificationPhysicalprocessing,andpackagingGood Manufacturing Practice Guide for Active Pharmaceutical Ingredients2. QUALITY MANAGEMENT2.1 Principles2.10 Quality should be the responsibility of all persons involved in manufacturing.2.11 Each manufacturer should establish, document, and implement an effectivesystem for managing quality that involves the active participation of management and appropriate manufacturing personnel.2.12 The system for managing quality should encompass the organisational structure,procedures, processes and resources, as well as activities necessary to ensure confidence that the API will meet its intended specifications for quality and purity. All quality related activities should be defined and documented.2.13 There should be a quality unit(s) that is independent of production and thatfulfills both quality assurance (QA) and quality control (QC) responsibilities. This can be in the form of separate QA and QC units or a single individual or group, depending upon the size and structure of the organization.2.14 The persons authorised to release intermediates and APIs should be specified. 2.15 All quality related activities should be recorded at the time they are performed.2.16 Any deviation from established procedures should be documented and explained.Critical deviations should be investigated, and the investigation and its conclusions should be documented.2.17 No materials should be released or used before the satisfactory completion ofevaluation by the quality unit(s) unless there are appropriate systems in place to allow for such use (e.g. release under quarantine as described in Section 10.20 or the use of raw materials or intermediates pending completion of evaluation).2.18 Procedures should exist for notifying responsible management in a timely mannerof regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc.).2.2 Responsibilities of the Quality Unit(s)2.20 The quality unit(s) should be involved in all quality-related matters.2.21 The quality unit(s) should review and approve all appropriate quality-relateddocuments.2.22 The main responsibilities of the independent quality unit(s) should not bedelegated. These responsibilities should be described in writing and should include but not necessarily be limited to:1. Releasing or rejecting all APIs. Releasing or rejecting intermediates for useoutside the control of the manufacturing company;2. Establishing a system to release or reject raw materials, intermediates,packaging and labelling materials;3. Reviewing completed batch production and laboratory control records ofcritical process steps before release of the API for distribution;4. Making sure that critical deviations are investigated and resolved;5. Approving all specifications and master production instructions;6. Approving all procedures impacting the quality of intermediates or APIs;Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients7. Making sure that internal audits (self-inspections) are performed;8. Approving intermediate and API contract manufacturers;9. Approving changes that potentially impact intermediate or API quality;10. Reviewing and approving validation protocols and reports;11. Making sure that quality related complaints are investigated and resolved;12. Making sure that effective systems are used for maintaining and calibratingcritical equipment;13. Making sure that materials are appropriately tested and the results arereported;14. Making sure that there is stability data to support retest or expiry dates andstorage conditions on APIs and/or intermediates where appropriate; and15. Performing product quality reviews (as defined in Section 2.5).2.3 Responsibility for Production ActivitiesThe responsibility for production activities should be described in writing, and should include but not necessarily be limited to:1. Preparing, reviewing, approving and distributing the instructions for theproduction of intermediates or APIs according to written procedures;2. Producing APIs and, when appropriate, intermediates according to pre-approved instructions;3. Reviewing all production batch records and ensuring that these arecompleted and signed;4. Making sure that all production deviations are reported and evaluated andthat critical deviations are investigated and the conclusions are recorded;5. Making sure that production facilities are clean and when appropriatedisinfected;6. Making sure that the necessary calibrations are performed and recordskept;7. Making sure that the premises and equipment are maintained and recordskept;8. Making sure that validation protocols and reports are reviewed andapproved;9. Evaluating proposed changes in product, process or equipment; and10. Making sure that new and, when appropriate, modified facilities andequipment are qualified.2.4 Internal Audits (Self Inspection)2.40 In order to verify compliance with the principles of GMP for APIs, regularinternal audits should be performed in accordance with an approved schedule. 2.41 Audit findings and corrective actions should be documented and brought to theattention of responsible management of the firm. Agreed corrective actions should be completed in a timely and effective manner.2.5 Product Quality Review2.50 Regular quality reviews of APIs should be conducted with the objective ofverifying the consistency of the process. Such reviews should normally be conducted and documented annually and should include at least:− A review of critical in-process control and critical API test results;− A review of all batches that failed to meet established specification(s);− A review of all critical deviations or non-conformances and related investigations;− A review of any changes carried out to the processes or analytical methods;− A review of results of the stability monitoring program;− A review of all quality-related returns, complaints and recalls; and− A review of adequacy of corrective actions.2.51 The results of this review should be evaluated and an assessment made ofwhether corrective action or any revalidation should be undertaken. Reasons for such corrective action should be documented. Agreed corrective actions should be completed in a timely and effective manner.3. PERSONNEL3.1 Personnel Qualifications3.10 There should be an adequate number of personnel qualified by appropriateeducation, training and/or experience to perform and supervise the manufacture of intermediates and APIs.3.11 The responsibilities of all personnel engaged in the manufacture of intermediatesand APIs should be specified in writing.3.12 Training should be regularly conducted by qualified individuals and should cover,at a minimum, the particular operations that the employee performs and GMP as it relates to the employee's functions. Records of training should be maintained.Training should be periodically assessed.3.2 Personnel Hygiene3.20 Personnel should practice good sanitation and health habits.3.21 Personnel should wear clean clothing suitable for the manufacturing activity withwhich they are involved and this clothing should be changed when appropriate.Additional protective apparel, such as head, face, hand, and arm coverings, should be worn when necessary, to protect intermediates and APIs from contamination.3.22 Personnel should avoid direct contact with intermediates or APIs.3.23 Smoking, eating, drinking, chewing and the storage of food should be restricted tocertain designated areas separate from the manufacturing areas.3.24 Personnel suffering from an infectious disease or having open lesions on theexposed surface of the body should not engage in activities that could result in compromising the quality of APIs. Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions should be excluded from activities where the health condition could adversely affect the quality of the APIs until the condition is corrected orqualified medical personnel determine that the person's inclusion would not jeopardize the safety or quality of the APIs.3.3 Consultants3.30 Consultants advising on the manufacture and control of intermediates or APIsshould have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained.3.31 Records should be maintained stating the name, address, qualifications, and typeof service provided by these consultants.4. BUILDINGS AND FACILITIES4.1 Design and Construction4.10 Buildings and facilities used in the manufacture of intermediates and APIs shouldbe located, designed, and constructed to facilitate cleaning, maintenance, and operations as appropriate to the type and stage of manufacture. Facilities should also be designed to minimize potential contamination. Where microbiological specifications have been established for the intermediate or API, facilities should also be designed to limit exposure to objectionable microbiological contaminants as appropriate.4.11 Buildings and facilities should have adequate space for the orderly placement ofequipment and materials to prevent mix-ups and contamination.4.12 Where the equipment itself (e.g., closed or contained systems) provides adequateprotection of the material, such equipment can be located outdoors.4.13 The flow of materials and personnel through the building or facilities should bedesigned to prevent mix-ups or contamination.4.14 There should be defined areas or other control systems for the followingactivities:− Receipt, identification, sampling, and quarantine of incoming materials, pending release or rejection;− Quarantine before release or rejection of intermediates and APIs;− Sampling of intermediates and APIs;− Holding rejected materials before further disposition (e.g., return, reprocessing or destruction);− Storage of released materials;− Production operations;− Packaging and labelling operations; and− Laboratory operations.4.15 Adequate, clean washing and toilet facilities should be provided for personnel.These washing facilities should be equipped with hot and cold water as appropriate, soap or detergent, air driers or single service towels. The washing and toilet facilities should be separate from, but easily accessible to, manufacturing areas. Adequate facilities for showering and/or changing clothes should be provided, when appropriate.4.16 Laboratory areas/operations should normally be separated from production areas.Some laboratory areas, in particular those used for in-process controls, can be located in production areas, provided the operations of the production process do not adversely affect the accuracy of the laboratory measurements, and the laboratory and its operations do not adversely affect the production process or intermediate or API.4.2 Utilities4.20 All utilities that could impact on product quality (e.g. steam, gases, compressedair, and heating, ventilation and air conditioning) should be qualified and appropriately monitored and action should be taken when limits are exceeded.Drawings for these utility systems should be available.4.21 Adequate ventilation, air filtration and exhaust systems should be provided,where appropriate. These systems should be designed and constructed to minimise risks of contamination and cross-contamination and should include equipment for control of air pressure, microorganisms (if appropriate), dust, humidity, and temperature, as appropriate to the stage of manufacture.Particular attention should be given to areas where APIs are exposed to the environment.4.22 If air is recirculated to production areas, appropriate measures should be takento control risks of contamination and cross-contamination.4.23 Permanently installed pipework should be appropriately identified. This can beaccomplished by identifying individual lines, documentation, computer control systems, or alternative means. Pipework should be located to avoid risks of contamination of the intermediate or API.4.24 Drains should be of adequate size and should be provided with an air break or asuitable device to prevent back-siphonage, when appropriate.4.3 Water4.30 Water used in the manufacture of APIs should be demonstrated to be suitable forits intended use.4.31 Unless otherwise justified, process water should, at a minimum, meet WorldHealth Organization (WHO) guidelines for drinking (potable) water quality.4.32 If drinking (potable) water is insufficient to assure API quality, and tighterchemical and/or microbiological water quality specifications are called for, appropriate specifications for physical/chemical attributes, total microbial counts, objectionable organisms and/or endotoxins should be established.4.33 Where water used in the process is treated by the manufacturer to achieve adefined quality, the treatment process should be validated and monitored with appropriate action limits.4.34 Where the manufacturer of a non-sterile API either intends or claims that it issuitable for use in further processing to produce a sterile drug (medicinal) product, water used in the final isolation and purification steps should be monitored and controlled for total microbial counts, objectionable organisms, and endotoxins.4.4 Containment4.40 Dedicated production areas, which can include facilities, air handling equipmentand/or process equipment, should be employed in the production of highly sensitizing materials, such as penicillins or cephalosporins.4.41 Dedicated production areas should also be considered when material of aninfectious nature or high pharmacological activity or toxicity is involved (e.g., certain steroids or cytotoxic anti-cancer agents) unless validated inactivation and/or cleaning procedures are established and maintained.4.42 Appropriate measures should be established and implemented to prevent cross-contamination from personnel, materials, etc. moving from one dedicated area to another.4.43 Any production activities (including weighing, milling, or packaging) of highlytoxic non-pharmaceutical materials such as herbicides and pesticides should not be conducted using the buildings and/or equipment being used for the production of APIs. Handling and storage of these highly toxic non-pharmaceutical materials should be separate from APIs.4.5 Lighting4.50 Adequate lighting should be provided in all areas to facilitate cleaning,maintenance, and proper operations.4.6 Sewage and Refuse4.60 Sewage, refuse, and other waste (e.g., solids, liquids, or gaseous by-products frommanufacturing) in and from buildings and the immediate surrounding area should be disposed of in a safe, timely, and sanitary manner. Containers and/or pipes for waste material should be clearly identified.4.7 Sanitation and Maintenance4.70 Buildings used in the manufacture of intermediates and APIs should be properlymaintained and repaired and kept in a clean condition.4.71 Written procedures should be established assigning responsibility for sanitationand describing the cleaning schedules, methods, equipment, and materials to be used in cleaning buildings and facilities.4.72 When necessary, written procedures should also be established for the use ofsuitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents to prevent the contamination of equipment, raw materials, packaging/labelling materials, intermediates, and APIs.5. PROCESS EQUIPMENT5.1 Design and Construction5.10 Equipment used in the manufacture of intermediates and APIs should be ofappropriate design and adequate size, and suitably located for its intended use, cleaning, sanitization (where appropriate), and maintenance.5.11 Equipment should be constructed so that surfaces that contact raw materials,intermediates, or APIs do not alter the quality of the intermediates and APIs beyond the official or other established specifications.5.12 Production equipment should only be used within its qualified operating range.。

国富论的英文版原名Here is an essay on the English title of "The Wealth of Nations" with over 1000 words, written in English without any additional titles or unnecessary punctuation marks.An Inquiry into the Nature and Causes of the Wealth of Nations is the original English title of the groundbreaking economic treatise written by the renowned Scottish philosopher and economist Adam Smith, first published in 1776. This seminal work is widely regarded as one of the most influential books in the history of economic thought, laying the foundations for modern economic theory and policy.At the heart of Smith's masterpiece is the idea that the pursuit of individual self-interest, when channeled through the mechanisms of the free market, can lead to the greatest benefit for society as a whole. This concept, known as the "invisible hand," was a revolutionary departure from the prevailing mercantilist economic doctrines of the time, which favored government intervention and protectionism.Smith's central thesis is that the wealth of a nation is not determinedby the amount of precious metals or bullion it possesses, as the mercantilists believed, but rather by the productive capacity of its labor force and the efficiency of its economic system. He argued that individuals, motivated by their own self-interest, will engage in the most productive activities, leading to the optimal allocation of resources and the maximization of national wealth.The Wealth of Nations is divided into five books, each of which explores a different aspect of Smith's economic philosophy. The first book delves into the division of labor, the factors that determine the value of goods, and the role of money in the economy. The second book examines the nature and sources of capital, the accumulation of wealth, and the role of banking and financial institutions.The third book focuses on the historical development of economic systems, tracing the evolution from feudalism to capitalism and the rise of cities and the commercial class. The fourth book critiques the mercantilist system and advocates for the principles of free trade and limited government intervention, while the fifth book discusses the role of the state in providing public goods and maintaining the rule of law.One of the most enduring and influential ideas in The Wealth of Nations is Smith's concept of the "invisible hand," which posits that the pursuit of individual self-interest, when unhindered bygovernment interference, will lead to the most efficient allocation of resources and the greatest benefit for society as a whole. This idea has been central to the development of classical and neoclassical economic thought, and has had a profound impact on policy debates and the development of modern capitalism.Another key contribution of The Wealth of Nations is its emphasis on the division of labor as a driver of productivity and economic growth. Smith argued that the subdivision of tasks and the specialization of workers led to increased efficiency and output, a concept that has been widely adopted in industrial and manufacturing processes.The Wealth of Nations also made significant contributions to the understanding of the role of money in the economy, the nature of capital and its accumulation, and the historical development of economic systems. Smith's insights into these areas have had a lasting impact on economic theory and have continued to be the subject of scholarly debate and research.Despite its enduring influence, The Wealth of Nations has also been the subject of criticism and debate. Some scholars have argued that Smith's theories fail to fully account for the complexities of modern economic systems, particularly the role of government intervention in addressing market failures and ensuring social welfare. Others have critiqued the limited scope of Smith's analysis, which focusedprimarily on the British economy and did not fully consider the perspectives of non-Western societies.Nevertheless, The Wealth of Nations remains a seminal work in the history of economic thought, and its influence continues to be felt in both the academic and policy realms. Its insights into the nature of economic systems, the role of the individual, and the dynamics of wealth creation have made it a touchstone for economists, policymakers, and scholars alike.In conclusion, the English title of Adam Smith's masterpiece, "An Inquiry into the Nature and Causes of the Wealth of Nations," reflects the breadth and depth of its analysis, as well as its enduring significance in the field of economics. The work's focus on the role of the individual, the free market, and the drivers of economic growth have made it a foundational text for modern economic theory and policy, and its legacy continues to shape our understanding of the complex and ever-evolving world of economics.。

金字塔原理第一章解读（中英文实用版）Title: The Pyramid Principle - Chapter 1 InterpretationThe Pyramid Principle is a book that delves into the art of logical thinking and effective communication.The first chapter sets the stage for understanding the concept of thinking in a structured manner.在《金字塔原理》这本书中，作者深入探讨了逻辑思维和有效沟通的艺术。

第一章为读者理解结构化思维的概念奠定了基础。

The chapter emphasizes the importance of creating a clear and concise message that is easily understood by others.It highlights the significance of using a top-down approach in presenting information, starting with the main idea and then gradually expanding on supporting details.本章强调了创建清晰简洁的信息对于他人易于理解的重要性。

它突出了在呈现信息时采用自上而下的方法的重要性，从主要观点开始，然后逐渐扩展到支持性细节。

Furthermore, the chapter introduces the concept of "thinking in pyramid structure," which involves organizing ideas in a hierarchical manner.This structure allows for a more focused and organized presentation of thoughts, making it easier for the audience to follow and understand the message being conveyed.此外，本章介绍了“金字塔结构思维”的概念，涉及以层次化的方式组织思想。

商业法则英语作文Title: The Essence of Business Principles。

In the dynamic realm of commerce, certain principles stand as immutable guides, shaping the landscape of business transactions and relationships. These principles, often rooted in ethical, legal, and practical considerations, serve as the bedrock upon which successful enterprises are built. Here, we delve into some of the fundamental business principles that govern modern economic activities.1. Integrity and Honesty: At the core of every prosperous business lies integrity and honesty. Upholding ethical standards in all dealings fosters trust among stakeholders, be they customers, employees, or partners. Transparency and truthfulness build long-term relationships and enhance a company's reputation.2. Fair Competition: In the marketplace, faircompetition is essential for innovation and consumer choice. Businesses must compete on merit, offering superiorproducts or services rather than resorting to unethical tactics such as price-fixing or monopolistic behavior. Fair competition ensures a level playing field, driving continuous improvement and benefiting consumers.3. Respect for Contracts: Contracts serve as the cornerstone of business agreements, delineating rights, responsibilities, and obligations of parties involved. Adhering to the terms of contracts demonstrates reliability and professionalism, fostering a conducive environment for collaboration and mitigating disputes.4. Protection of Intellectual Property: Intellectual property rights safeguard innovations, creations, and proprietary information vital to business success. Respect for intellectual property rights not only encourages innovation but also ensures that creators and innovatorsare duly rewarded for their contributions.5. Corporate Social Responsibility (CSR): Beyondprofit-making objectives, businesses have a responsibility towards society and the environment. Embracing CSRinitiatives demonstrates a commitment to sustainable practices, community welfare, and environmental stewardship. CSR not only enhances a company's reputation but also contributes to long-term societal well-being.6. Compliance with Laws and Regulations: Legal compliance is non-negotiable in the business world.Adhering to laws and regulations ensures ethical conduct, protects stakeholders' interests, and mitigates legal risks. Businesses must stay abreast of evolving regulatory frameworks and proactively adjust their practices to remain compliant.7. Customer Focus and Satisfaction: Customers are the lifeblood of any business, and prioritizing their needs and satisfaction is paramount. Businesses should strive to deliver value, exceed customer expectations, and build lasting relationships through exceptional products, services, and support.8. Continuous Improvement and Adaptation: In today's dynamic business environment, adaptability and continuous improvement are indispensable. Successful businesses anticipate changes, embrace innovation, and constantly evolve to meet evolving market demands and challenges.9. Risk Management: Every business venture entails inherent risks, and effective risk management is essential for sustainable growth. Identifying, assessing, and mitigating risks, whether financial, operational, or strategic, safeguards against adverse outcomes and enhances resilience in the face of uncertainty.10. Ethical Leadership: Ethical leadership sets the tone for organizational culture and behavior. Leaders who exemplify integrity, fairness, and accountability inspire trust and motivate employees to uphold ethical standards in their conduct and decision-making.In conclusion, adherence to these fundamental business principles fosters a conducive environment for sustainable growth, innovation, and responsible corporate citizenship.By integrating these principles into their operations and culture, businesses can not only achieve financial success but also contribute positively to society and the broader economy.。