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PART 210 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING，PROCESSING，PACKING, OR HOLDING OF DRUGS；GENERAL210部分有关于生产、加工、包装和药品的储存的现行GMP;一般准则Sec. 210.1 Status of current goodmanufacturing practice regulations。
210.1 cGMP的法规地位。
(a）The regulations set forth in this part and in parts 211 through 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture，processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess. （a）在本部分及本章第211－226部分中所陈述的法规,为现行GMP最低要求，适用于药品制造、加工、包装或贮存中所采用的方法及所使用的设施或控制手段,以保证该药品符合《联邦食品、药品及化妆品法案》（以下简称法案）对安全性的要求，具有均一性和效价（或含量)并符合或代表其生产过程的质量及纯度等特征。
QbR Frequently Asked QuestionsDisclaimer: These are general answers and may not be applicable to every product. Each ANDA is reviewed individually. This document represents the Office of Generic Drugs’s (OGD’s) current thinking on these topics.Format and SubmissionHow should QbR ANDAs be submitted?OGD’s QbR was designed with the expectation that ANDA applications would beorganized according to the Common Technical Document (CTD) format, a submissionformat adopted by multiple regulatory bodies including FDA. Generic firms are strongly recommended to submit their ANDAs in the CTD format (either eCTD or paper) tofacilitate implementation of the QbR. The ANDA Checklist for completeness andacceptability of an application for filing can be found on the OGD web page:/cder/ogd/anda_checklist.pdf .What is a QOS?The Quality Overall Summary (QOS) is the part of the CTD format that provides asummary of the CMC aspects of the application. It is an important tool to make the QbR review process more efficient.How long should a QOS be?OGD believes the CTD guidance1 recommendation of 40 pages to be an appropriatecompromise between level of detail and concision. The CTD guidance recommendation does not include tables and figures.The same information should not be included in multiple locations in the QOS. Instead of repeating information, refer to the first location of the original information in the QOS by CTD section number.Should the QOS be submitted electronically?All applications should include an electronic QOS. For paper submissions, it isrecommended that both an electronic QOS and a paper QOS be included.What file format should be used for the QOS?All applications, both eCTD and paper submissions, should have an electronic QOS. The electronic QOS should be contained in one document. Do not provide separate files foreach section or question.The electronic QOS should be provided as both a pdf and a Microsoft Word file. Microsoft Word files should be readable by Word 2003.1 Guidance for Industry M4Q: The CTD – Quality (August 2001) /cder/guidance/4539Q.htmWhat fonts should be used in the QOS?Because of FDA’s internal data management systems, please use only use these TrueType fonts: Times New Roman, Arial, Courier New. Times New Roman is recommended as the main text font.Should the applicable QbR question be presented within the body of Module 2 of the relevant section, followed by sponsor's answer?Yes, include all the QbR questions without deletion in the QOS.Can the granularity of module 3 be used in module 2?Yes, the granularity can be used for section and subsection headings. However, the QOS should always be submitted as a single file.Can color be used in the QOS?Yes, but sponsors should ensure that the QOS is legible when printed in black and white.Colored text should not be used.Is the QOS format available on OGD webpage and questions therein mandatory to be followed?For an efficient review process, OGD desires all applications to be in a consistent format.See the OGD QbR questions and example QOS:/cder/ogd/QbR-Quality_Overall_Summary_Outline.doc/cder/ogd/OGD_Model_Quality_Overall_ Summary.pdf/cder/ogd/OGD_Model_QOS_IR_Product.pdfFor amendments to applications, should the documentation consist of a revision of the QOS? Would new PD reports be required?The QOS should not be updated after submission of the original ANDA. Any additional data (including any new PD reports) should be provided as a stand alone amendment.Responses to deficiencies should be provided in electronic format as both a pdf andMicrosoft Word file.After January 2007, what will happen to an application that does not have a QOS or contains an incomplete QOS?OGD will contact the sponsor and ask them to provide a QOS. If the sponsor provides the QOS before the application comes up for review, OGD will use the sponsor’s QOS.OGD’s QbR questions represent the current thinking about what information is essential to evaluate an ANDA. Reviewers will use deficiency letters to ask ANDA sponsors thequestions that are not answered in the sponsor’s QOS.In February 2007, 75% of ANDAs submitted contained a QOS.If a question is not applicable to a specific formulation or dosage form, should the question be deleted or unanswered?Sponsors should never delete a QbR question, but instead answer as not applicable, with a brief justification. Please answer all parts of multi-part questions.For sterile injectables, to what extent should sterility assurance be covered in QOS?The current QbR was not intended to cover data recommendations for Sterility Assurance information. In the future, other summaries will cover other disciplines.MAPP 5040.1, effective date 5/24/04, specifies location of the microbiology information in the CTD format.Where in the CTD should an applicant provide comparative dissolution data between the generic and RLD?The comparison between the final ANDA formulation and the RLD should be provided in5.3.1, this comparison should be summarized in the QOS. Comparisons with otherformulations conducted during development should be included in 3.P.2.Is it possible to submit an amendment in CTD format for a product that was already submitted in the old ANDA format?No, all amendments to an application under review should use the same format as theoriginal submission.How is a paper CTD to be paginated?“Page numbering in the CTD format should be at the document level and not at the volume or module level. (The entire submission should never be numbered consecutively by page.) In general, all documents should have page numbers. Since the page numbering is at the document level, there should only be one set of page numbers for each document.”2. For paper submission, tabs locating sections and subsections are useful.For the ANDA submitted as in paper CTD format, can we submit the bioequivalence study report electronically? Or does the Agency require paper copy only?The bioequivalence summary tables should always be provided in electronic format.Will QbR lead to longer review times?Many of the current long review times result from applications that do not completelyaddress all of the review issues and OGD must request additional information through the deficiency process. This iterative process will be reduced with the use of the QbR template.Sponsors that provide a QOS that clearly and completely addresses all the questions in the QbR should find a reduction in the overall review time.Will DMFs for the drug substance be required to be in CTD if the ANDA is in CTD format?No. CTD format DMFs are recommended.What should be included in 3.2.R.1.P.2, Information on Components?COA’s for drug substance, excipients and packaging components used to produce theexhibit batch.2 Submitting Marketing Applications According to the ICH/CTD Format: General Considerations/cder/guidance/4707dft.pdfHow should an ANDA sponsor respond to deficiencies?OGD requests that sponsors provide a copy of the response to deficiencies in electronic format as both a pdf file and a Microsoft Word file.QUALITY OVERALL SUMMARY CONTENT QUESTIONS2.3 Introduction to the Quality Overall SummaryWhat information should be provided in the introduction?Proprietary Name of Drug Product:Non-Proprietary Name of Drug Product:Non-Proprietary Name of Drug Substance:Company Name:Dosage Form:Strength(s):Route of Administration:Proposed Indication(s):Maximum Daily Dose:2.3.S DRUG SUBSTANCEWhat if an ANDA contains two or more active ingredients?Prepare separate 2.3.S sections of the QOS for each API. Label them 2.3.S [API 1] and2.3.S [API 2].What if an ANDA contains two or more suppliers of the same active ingredient?Provide one 2.3.S section. Information that is common between suppliers should not be repeated. Information that is not common between suppliers (e.g. different manufacturing processes) should have separate sections and be labeled accordingly (drug substance,manufacturer 1) and (drug substance, manufacturer 2).Can information in this section be provided by reference to a DMF?See individual questions for details. As a general overview:•Information to be referenced to the DMFo Drug substance structure elucidation;o Drug substance manufacturing process and controls;o Container/closure system used for packaging and storage of the drugsubstance;o Drug substance stability.•Information requested from ANDA Sponsoro Physicochemical properties;o Adequate drug substance specification and test methods including structure confirmation;o Impurity profile in drug substance (process impurity or degradant);o Limits for impurity/residual solvent limits;o Method validation/verification;o Reference standard.2.3.S.1 General InformationWhat are the nomenclature, molecular structure, molecular formula, and molecular weight?What format should be used for this information?Chemical Name:CAS #:USAN:Molecular Structure:Molecular Formula:Molecular Weight:What are the physicochemical properties including physical description, pKa, polymorphism, aqueous solubility (as function of pH), hygroscopicity, melting point, and partition coefficient?What format should be used for this information?Physical Description:pKa:Polymorphism:Solubility Characteristics:Hygroscopicity:Melting Point:Partition Coefficient:Should all of these properties be reported? Even if they are not critical?Report ALL physicochemical properties listed in the question even if they are not critical.If a property is not quantified, explain why, for example: “No pKa because there are no ionizable groups in the chemical structure” or “No melting point because compounddegrades on heating”.What solubility data should be provided?The BCS solubility classification3 of the drug substance should be determined for oral dosage forms.Report aqueous solubility as a function of pH at 37º C in tabular form. Provide actualvalues for the solubility and not descriptive phrases such as “slightly soluble”.3 See BCS guidance /cder/guidance/3618fnl.pdf for definitionSolvent Media and pH Solubility Form I(mg/ml) Solubility Form II(mg/ml)Should pH-solubility profiles be provided for all known polymorphic forms?No, it is essential that the pH-solubility profile be provided for the form present in the drug product. The relative solubility (at one pH) should be provided for any other more stable forms.Physicochemical information such as polymorphic form, pKa, solubility, is usually in the confidential section of DMF. Is reference to a DMF acceptable for this type of information?No, knowledge of API physicochemical properties is crucial to the successful development of a robust formulation and manufacturing process. In view of the critical nature of thisinformation, OGD does not consider simple reference to the DMF to be acceptable.The Guidance for Industry: M4Q: The CTD-Quality Questions and Answers/ Location Issues says only the polymorphic form used in the drug product should be described in S.1 and other known polymorphic forms should be described in S.3. OGD’s examples placed information about all known polymorphic forms in S.1. Where does OGD want this information?This information may be included in either S.1 or in S.3. Wherever presented, list allpolymorphic forms reported in literature and provide brief discussion (i.e., which one is the most stable form) and indicate which form is used for this product.Other polymorph information should be presented by the ANDA applicant as follows: • 2.3.S.3 Characterization: Studies performed (if any) and methods used to identify the potential polymorphic forms of the drug substance. (x-ray, DSC, and literature) • 2.3.S.4 Specification: Justification of whether a polymorph specification is needed and the proposed analytical method• 2.3.P.2.1.1 Pharmaceutical Development –Drug Substance: Studies conducted to evaluate if polymorphic form affects drug product propertiesWhy does OGD need to know the partition coefficient and other physicochemical properties?Physical and chemical properties may affect drug product development, manufacture, or performance.2.3.S.2 ManufactureWho manufactures the drug substance?How should this be answered?Provide the name, address, and responsibility of each manufacturer, including contractor, and each proposed production site or facility involved in manufacturing and testing.Include the DMF number, refer to the Letter of Authorization in the body of data, andidentify the US Agent (if applicable)How do the manufacturing processes and controls ensure consistent production of the drug substance?Can this question be answered by reference to a DMF?Yes. It is preferable to mention the source of the material (synthetic or natural) when both sources are available.The DMF holder’s COA for the batch used to manufacture the exhibit batches should be provided in the body of data at 3.2.S.4.4.If there is no DMF, what information should be provided?A complete description of the manufacturing process and controls used to produce the drugsubstance.2.3.S.3 CharacterizationHow was the drug substance structure elucidated and characterized?Can structure elucidation be answered by reference to a DMF?Yes.What information should be provided for chiral drug substances?When the drug substance contains one or more chiral centers, the applicant should indicate whether it is a racemate or a specific enantiomer.When the drug substance is a specific enantiomer, then tests to identify and/or quantify that enantiomer should be included. Discussion of chirality should include the potential forinterconversion between enantiomers (e.g. racemization/epimerization).How were potential impurities identified and characterized?List related compounds potentially present in the drug substance. Identify impurities bynames, structures, or RRT/HPLC. Under origin, classify impurities as process impurities and/or degradants.Structure Origin ID ChemicalName[SpecifiedImpurity]Is identification of potential impurities needed if there is a USP related substances method?Yes.Can this question be answered by reference to a DMF?The ANDA should include a list of potential impurities and their origins. The methodsused to identify and characterize these impurities can be incorporated by reference to the DMF.According to the CTD guidance, section S.3 should contain a list of potential impurities and the basis for the acceptance criteria for impurities, however in the OGD examples this information was in section S.4. Where should it go?This information may be included in either S.3 or in S.4.2.3.S.4 Control of Drug SubstanceWhat is the drug substance specification? Does it include all the critical drug substance attributes that affect the manufacturing and quality of the drug product?What format should be used for presenting the specification?Include a table of specifications. Include the results for the batch(es) of drug substance used to produce the exhibit batch(es). Identify impurities in a footnote. Test results and acceptance criteria should be provided as numerical values with proper units whenapplicable.Tests Acceptancecriteria AnalyticalprocedureTest results for Lot#AppearanceIdentificationA:B:AssayResidualSolventsSpecified ImpuritiesRC1RC2RC3Any UnspecifiedImpurityTotal Impurities[AdditionalSpecification]*RC 1: [impurity identity]RC 2: [impurity identity]RC 3: [impurity identity]What tests should be included in the drug substance specification?USP drugs must meet the USP monograph requirements, but other tests should be included when appropriate. For USP and non USP drugs, other references (EP, BP, JP, the DMF holder’s specifications, and ICH guidances) can be used to help identify appropriate tests.Only relevant tests should be included in the specification. Justify whether specific tests such as optical rotation, water content, impurities, residual solvents; solid state properties(e.g. polymorphic form, particle size distribution, etc) should be included in thespecification of drug substance or not.Does OGD accept foreign pharmacopeia tests and criteria for drug substances?There are several examples where a drug substance is covered by a monograph in EP or JP, but not in the USP. ANDA and DMF holders can obtain information regardingphysicochemical properties, structure of related impurities, storage conditions, analytical test methods, and reference standards from EP or JP to support their submission to OGD.Although the USP remains our official compendium, we usually accept EP when the drug substance is not in USP (However, a complete validation report for EP methods should be provided in the ANDA).For each test in the specification, is the analytical method(s) suitable for its intended use and, if necessary, validated? What is the justification for the acceptance criterion?What level of detail does OGD expect for the analytical method justifications and validations?Provide a summary of each non-USP method. This can be in a tabular or descriptive form.It should include the critical parameters for the method and system suitability criteria ifapplicable. See an example in section 2.3.P.5 of this document.For each analytical procedure, provide a page number/link to the location of validationinformation in Module 3. For quantitative non-compendial analytical methods, provide a summary table for the method validation. See an example in section 2.3.P.5 of thisdocument.Is validation needed for a USP method?No, but USP methods should be verified and an ANDA sponsor should ensure that theUSP assay method is specific (e.g. main peak can be separated from all process impurities arising from their manufacturing process and from degradation products) and the USPrelated substance method is specific (e.g. all the process impurities and degradants can be separated from each other and also separated from main peak).Is validation needed if the USP method is modified or replaced by an in-house method?Yes. Data supporting the equivalence or superiority of the in-house method should beprovided. In case of a dispute, the USP method will be considered the official method.Is reference to the DMF for drug substance analytical method validations acceptable?No. ANDA sponsors need to either provide full validation reports from the ANDA holder or reference full validation reports from the DMF holder (provided there is a copy of the method validation report in the ANDA and method verification from the ANDA holder). AppearanceIdentityAssayImpurities (Organic impurities)What format should be used for related substances?List related compounds potentially present in the drug substance. (Either here or S.3)Name Structure Origin[SpecifiedImpurity]Provide batch results and justifications for the proposed acceptance criteria. See guidance on ANDA DS impurities4 for acceptable justifications. If the DS is compendial, include the USP limits in the table. If the RLD product is used for justification/qualification, then its results should also be included. If an ICH justification is used, then the calculation of the ICH limits should be explained.To use the ICH limits, determine the Maximum Daily Dose (MDD) indicated in the label and use it to calculate the ICH Thresholds: Reporting Threshold (RT), Identification1. The amount of drug substance administered per day2. Higher reporting thresholds should be scientifically justified3. Lower thresholds can be appropriate if the impurity is unusually toxicSponsors can use the ICH limits to ensure the LOQ for the analytical method is equal or below the RT, establish the limit for “Any Unspecified Impurity” to equal or below the IT, and establish limits for each “Specified Identified Impurity” and each “SpecifiedUnidentified Impurity”5 to equal or below the QT.An impurity must be qualified if a limit is established above the QT. Options forqualification include reference to the specific impurity listed in a USP monograph,comparison to the RLD product, identifying the impurity as a significant metabolite of the drug substance, literature references including other compendial monographs (EP, BP, JP), or conducting a toxicity study.4/cder/guidance/6422dft.pdf5 The ANDA DS guidance states “For unidentified impurities to be listed in the drug substance specification, we recommend that you clearly state the procedure used and assumptions made in establishing the level of the impurity. It is important that unidentified specified impurities be referred to by an appropriate qualitative analytical descriptive label (e.g., unidentified A, unidentified with relative retention of 0.9)”. Q3A(R) states “When identification of an impurity is not feasible, a summary of the laboratory studies demonstrating the unsuccessful effort should be included in the application.”Name DrugSubstance(Lot #)USPLimit forDrugSubstanceRLDDrugProduct(Lot #)ProposedAcceptancecriteriaJustification[Specified Impurity,Identified][BatchResults][BatchResults][SpecifiedImpurity,Unidentified]Any UnspecifiedImpurityTotalImpuritiesInclude the column for RLD drug product only if that data is used to justify the drugsubstance limit (example a process impurity that is also found in the RLD).What is OGD’s policy on genotoxic impurities?FDA is developing a guidance for genotoxic impurities. According to the ICH Q3A lower thresholds are appropriate for impurities that are unusally toxic.If impurities levels for an approved generic drug are higher than the RLD, can the approved generic drug data be used as justification for a higher impurity specification?According to ANDA DP and DS Impurity guidances, any approved drug product can be used to qualify an impurity level. However, the guidances qualify this by later stating “This approved human drug product is generally the reference listed drug (RLD). However, you may also compare the profile to a different drug product with the same route ofadministration and similar characteristics (e.g. tablet versus capsule) if samples of thereference listed drug are unavailable or in the case of an ANDA submitted pursuant to a suitability petition.”What if there are no impurities’ tests found in the USP monograph for a USP drug substance? What should the ANDA sponsor do?Please work with your supplier (DMF Holder) to ensure that potential synthetic process impurities (e.g. isomers (if any), side reaction products), degradation impurities, metalcatalysts, and residual solvents are adequately captured by your impurities test method.There may be information available in published literature as well, regarding potentialimpurities.Can levels of an impurity found in the RLD and identified by RRT be used for qualification?Qualification of a specified unidentified impurity by means of comparative RRT, UVspectra, and mass spectrometry with the RLD may be acceptable. However, the ANDAsponsor should make every attempt to identify the impurity.If levels are higher than in an approved drug product then the sponsor should provide data for qualification of the safety of this impurity at this level.Can a limit from a USP monograph for “any unspecified impurity” be used to justify a limit for “any unspecified impurity” greater than the ICH Q3 identification threshold?No. Any unspecified impurity (any unknown) limit should not exceed ICH Q3A “IT”based on MDD. Non-specific compendial acceptance criteria (e.g. Any Individual Impurity is NMT 0.5%) should not be used for justification of proposed impurity acceptance criteria.However, if the USP limit is less than the ICH threshold, then the USP limit should be used. Can a limit for an identified impurity in the drug substance be qualified with data obtained from RLD drug product samples treated under the stressed conditions?No. Test various samples of marketed drug product over the span of its shelf life (ideally, near the end of shelf-life). Data generated from accelerated or stressed studies of the RLD is considered inappropriate.Impurities (Residual Solvents)Will OGD base residual solvent acceptance limits on ICH limits or process capability?The ICH guidance on residual solvents6 provides safety limits for residual solvents but also indicates that “residual solvents should be removed to the extent possible”. ANDA residual solvent limits should be within the ICH safety limits, but the review of the ANDA includes both of these considerations.OGD generally accepts the ICH limits when they are applied to the drug product.What about solvents that are not listed in Q3C?Levels should be qualified for safety.Impurities (Inorganic impurities)Polymorphic FormWhen is a specification on polymorphic form necessary?See ANDA polymorphism guidance7 for a detailed discussion.Particle SizeWhen is a drug substance particle size specification necessary?A specification should be included when the particle size is critical to either drug productperformance or manufacturing.For example, in a dry blending process, the particle size distribution of the drug substance and excipients may affect the mixing process. For a low solubility drug, the drug substance particle size may have a critical impact on the dissolution of the drug product. For a high solubility drug, particle size is often not critical to product performance.6 /cder/guidance/Q3Cfnl.pdf7/cder/guidance/6154dft.pdfWhat justification is necessary for drug substance particle size specifications?As for other API properties, the specificity and range of acceptance criteria for particle size, and the justification thereof, could vary from none to very tight limits, depending upon the criticality of this property for that drug product.Particle size specifications should be justified based on whether a change in particle sizewill affect the ability to manufacture the product or the final product performance.In general, a sponsor either should demonstrate through mechanistic understanding orempirical experiments how changes in material characteristics such as particle size affecttheir product.In the absence of pharmaceutical development studies, the particle size specificationshould represent the material used to produce the exhibit batch.When should the particle size be specified as distribution [d90,d50,d10] and when is a single point limit appropriate?When critical, a particle size should be specified by the distribution. There may be othersituations when a single point limit can be justified by pharmaceutical development studies.2.3.S.5 Reference StandardsHow were the primary reference standards certified?For non-compendial, in-house reference standards, what type of qualification data is recommended? Will a COA be sufficient?COA should be included in Module 3, along with details of its preparation, qualification,and characterization. This should be summarized in the QOS.In terms of the qualification data that may be requested, it is expected that these reference standards be of the highest possible purity (e.g. may necessitate an additionalrecrystallization beyond those used in the normal manufacturing process of the activeingredient) and be fully characterized (e.g. may necessitate in the qualification reportadditional characterization information such as proof of structure via NMR) beyond theidentification tests that are typically reported in a drug substance COA. StandardLaboratory Practice for preparation of reference standards entails recrystallization toconstant physical measurements or to literature values for the pure material.2.3.S.6 Container Closure SystemWhat container closure is used for packaging and storage of the drug substance?Can this question be answered by reference to a DMF?Yes.。
ReferenceCase Studies – Examples of CompetenciesPage 1Surf the waves CCreate the waves DBStay afloatPROCESS REDESIGNBUSINESS MODEL INNOVATION PRODUCT INNOVATIONOPTIMISATIONAbility to innovateACOMPLIANCESTAKEHOLDER ENGAGEMENTAbility to scaleSus tainabili t y c ompet enc i es (Cas e s tudies ) I J onath on Hanks I CSR Retreat As ia 2013 Page 2© Incite 2008Risk getting dumpedGOVERNANCECOLLABORATIVE VALUE CREATION1Surf the waves CProcess re-design: Significantly change products or processes to address societal challenges at any stage of the value chain.Create the waves DBusiness model innovation: Introduce a new, viable business model that addresses societal challenges and which at scale could help to reverse unsustainable trendsBStay afloatOptimisation: Develop human potential and reduce resource use and toxicity per unit of value added.Product innovation: Create viable new products or services that address societal challengesAbility to innovateARisk getting dumpedGovernance: Provide direction and systemic management of the organisation’s purpose, risks and responsibilitiesCollaborative value creation: Partner with an external organisation to design, produce or distribute products or services to address societal challengesAbility to scaleSus tainabili t y c ompet enc i es (Cas e s tudies ) I J onath on Hanks I CSR Retreat As ia 2013 Page 3Organisation: Ford Motor Company and Affiliates Project description: FORD2GO, part of Ford’s Blueprint for Mobility. Collaboration and technology for car sharing. Research has shown that in Europe 56% of people would consider car sharing. In another study one car share vehicle replaces nine to 13 vehicles on the road. • Their response is FORD2GO, a collaboration between Ford Germany, it’s dealers, branches and repair shops. A network of almost 1 900 locations • Each location is encouraged to purchase one or two vehicles; these vehicles are then rented via keyless entry to car share clients • Each location receives 80% of the usage fee, a portion goes to Ford and a portion to the software developerSus tainabili t y c ompet enc i es (Cas e s tudies )IJ onath on HanksICSR Retreat As ia 2013© Incite 2008 Page 4Compliance: Track and comply with legal requirements.Engagement: Listen to, interact and transact with a range of stakeholders.2Organisation: Tesla Motors Project: Realising that vehicle range is a key issue for many consumers, Tesla Motors has two solutions:• With the 85kWh battery, charging at supercharger stations is free, for life and it takes only 40 minutes to charge the battery to 80% capacity. The 60kWh model can be upgraded for US$2 000 for life. • If customers are in a rush, a complete battery swap can be made in 90 seconds, for a fee of US$60-80, about the same as filling up with conventional fuel.Sus tainabili t y c ompet enc i es (Cas e s tudies )IJ onath on HanksICSR Retreat As ia 2013Page 5Organisation: General Electric Project Description: Embedding environmental and economic sustainability in your strategy, across your value chain and operations – Ecomagination: • In 2010 GE set a goal to grow ecomagination revenue at twice the company growth by 2015, this was achieved in 2012. • Shifting from sustainable technology (wind, solar, fuel cells) to solutions for mining and oil and gas. • GE Ventures invests in small business and scales up great ideas by providing capital, technical and commercial expertise. • GE has reduced its absolute GHG emissions by 32% on the 2004 baseline and reduced fresh water use by 46% on the 2006 baseline.Sus tainabili t y c ompet enc i es (Cas e s tudies )IJ onath on HanksICSR Retreat As ia 2013Page 63Organisation: BMW Group Project Name: Demographic change of employees, BMW identified that their workforce was aging, what did that mean for productivity and how can experience be leveraged? • Working with engineers, employees, physiotherpists and doctors to make workplaces more appropriate • Tilted screens, elastic flooring and education programmes about how to move keep peoples bodies healthy • Stress optimised job rotation and age and healthappropriate shift plans were also implemented • These changes and simulating the predicted age structure ensure the production lines are as efficient as everSus tainabili t y c ompet enc i es (Cas e s tudies )IJ onath on HanksICSR Retreat As ia 2013Page 7Organisation: Nike Project Description: Mapping the value chain and sharing your IP • Nike has fully mapped its global contract factories and gives each a rating, with the aim of incentivising good performance. • Nike’s impacts are split into six areas, Energy & Climate, Labour, Chemistry, Water, Waste and Community • Recently launched, MAKING, a mobile application that ranks materials based on their environmental sustainability • MAKING is free and aids designers to choose lower impact materials • Demonstrates how recycling, organic, green chemistry and water conservation impact on a material’s sustainabilitySus tainabili t y c ompet enc i es (Cas e s tudies )IJ onath on HanksICSR Retreat As ia 2013Page 84Organisation: Nike Project: Collaboration across divisions designing a shoe made from one thread: • Listening to feedback from runners and their focus on waste reduction led Nike to start a journey of innovation • A four year design phase involving programmers, engineers and designers to create the perfect technology • The shoe upper is woven from a single thread, reducing weight and minimising waste • Resulting in a shoe that is lighter, fits better and has 80% less waste than a standard running shoeSus tainabili t y c ompet enc i es (Cas e s tudies )IJ onath on HanksICSR Retreat As ia 2013Page 9Organisation: Dockers Project Name: Wellthread apparel, creating lasting value through product durability • Product durability – maintaining a garments integrity: a new long staple yarn that holds up to the recycling process • Incremental efficiencies in water and energy use, building on learnings from Levis Water<Less collection • Rethinking the relationship between Levi’s and it’s suppliers lead to a 30% cost reduction that will be passed on to consumers • Core factories and their surrounding communities will benefit from tailor made investments by Levi’sSus tainabili t y c ompet enc i es (Cas e s tudies )IJ onath on HanksICSR Retreat As ia 2013Page 105Organisation: Unilever Project Name: Sustainable living plan – working across the entire value chain. Recognising that the majorty of their impacts are in sourcing or consumer use, Unilever is tackling the issues: • The lifebuoy brand aims to reach 1 billion consumers, promoting the benefit of washing hands with soap at key times • A key part of the programme is better livelihoods for growers, 450 000 tea farmers have been trained to date and a methodology is in development for assessing improvements in smallholder livelihoodsPage 11Organisation: SABMiller Project Name: Developing a cassava-based beer, through localising supply chains, partnering with other organisations and enterprise development • Cassava is difficult to farm on a commercial scale due to the quick deterioration of the root once harvested • Cassava is one of the most widely grown subsistence crops in Africa • SABMiller partnered with the Dutch Agricultural Development and Trading Company, finding an innovative solution, a mobile cassava processing plant, producing a product ready for the brewery • Through localisation, the cost of brewing is reduced, 1 500 smallholder farmers have additional income and environmental impacts are reducedSustainability competencies (Case studies)IJonathon Hanks IEM M Network Retreat Bangkok 2013Page 126Organisation: Global e-Sustainability Initiative (GeSI) Project description: A global ICT business partnership for sharing knowledge and resources to drive sustainable innovation in the sector. • GeSI works to identify, understand and share ICT solutions to help individuals, businesses and governments to be more resource efficient. • The organisation has a diverse and global membership base comprising more than 30 of the world’s leading ICT firms. • GeSI offers a network of support for member organisations as they address climate change, energy efficiency, e-waste management, resource efficiency, responsible supply chain practices and human rights. • Building on its membership’s collective experience and technical knowledge, GeSI is a hub for thought leadership for the industry. • Examples of projects include a carbon abatement study on cloud computing, and cooperating with the World Resources Institute (WRI) to provide guidance for the ICT sector in applying the Greenhouse Gas Protocol.Sustainability competencies (Case studies) I Jonathon Hanks I EM M Network Retreat Bangkok 2013Page 13Organisation: Vodafone Foundation in partnership with the UN Foundation Project description: Collaborating to use ICT-based solutions to solve developmental challenges. • This five-year technology partnership commenced in 2005. It was one of the first high profile initiatives to breach the public / private divide. • The partnership deployed ICT solutions to three developmental challenges.• Challenge 1: reliable communications during humanitarian crises. The solution: rapid response telecoms deployment, improving use of and access to life-saving mobile and satellite technology. Challenge 2: access to healthcare. The solution: mobile health data systems giving health workers rapid and reliable access to the data on, for example, medicine stocks and disease outbreaks. Challenge 3: accelerate ICT innovation for social development. The solution: developing and sharing thought leadership, research and recommendations to NGOs, governments and different industries.••Sustainability competencies (Case studies)IJonathon Hanks IEM M Network Retreat Bangkok 2013Page 147Organisation(s): MTN Project description: MTN’s ReadySet solar charger released in selected African markets, including Rwanda and Uganda. • In response to energy access challenges in emerging markets, MTN has begun to distribute the ComekaReadySet. This portable energy device can charge phones, power lights, tablets, and other devices. • It can be charged using solar power or electricity. • This energy access allows for the use of mobile technology and the use of MTN’s services in energy poor communities. It removes the need for dangerous fuels to generate power and can charge up to 10 phones once fully charged. • Added to these benefits, ReadySets provide opportunities for local entrepreneurship, with small businesses selling power on to communities.Sustainability competencies (Case studies)IJonathon Hanks IEM M Network Retreat Bangkok 2013Page 15Organisation(s): Grameenphone Project description: Using renewable energy to power base stations. • Grameenphone started the “Building Greener Network” project in 2007, committing to reduce its GHG emissions by 40% by 2015. • Currently, 134 sites that were previously powered by diesel are powered by solar and wind power. This environmental goal had the added benefit of driving energy cost efficiency. • The aim is to extend this technology to sites that are currently using electricity from the national power grid. • Grameenphone has positioned this initiative as a case study for the industry.Sustainability competencies (Case studies)IJonathon Hanks IEM M Network Retreat Bangkok 2013Page 168Organisation(s): European Institute of Innovation and Technology (EIT) ICT Labs Project description: The ICT labs are Knowledge and Innovation Communities set up by EIT, as an initiative of the European Union. • With these labs, EIT brings academic institutions and private organisations together to drive European leadership in ICT innovation. The aim is to leverage this innovation for economic growth and to improve Europeans’ quality of life. • EIT has 110 partners across Europe, including large companies such as Deutsche Telekom, Nokia and Alcatel-Lucent. The labs stimulate innovation by facilitating dialogue and collaboration between researchers, academics and businesses. • The ICT labs are focused on specific innovation areas, including smart cities and smart energy systems. • One of the primary overarching objectives of research and collaboration is to enable the ICT sector to support the growth of small and medium enterprises.Sustainability competencies (Case studies)IJonathon Hanks IEM M Network Retreat Bangkok 2013Page 17Organisation(s): IBM Project description: Finding applications for ICT products in smarter, better functioning cities. • IBM’s strategy responds to an increasing demand for more interconnected approaches to city planning. These are approaches in which major amenities such as traffic, power and water are managed in an integrated way. • IBM has identified a role for ICT, and several concrete business opportunities in the “smart city” of the future. This includes the management and use of data as a basis for better decision-making and planning for cities, and in order to increase resource efficiency. • The project has worked with large sets of raw data, converting this into knowledge that can be applied to solve challenges faced by government and businesses. • The IBM Smarter Cities initiative has already engaged in 200 projects across many different cities. Establishing trust and longterm partnerships is a key part of the success of these projects.Page 189Organisation: Ghanaian Government Project description: Using Public Private Partnerships to drive infrastructure and economic development • Ghana is currently facing significant infrastructure challenges that are proving to be constraints to economic development. • Infrastructure, specifically roads linking areas of economic activity, has been identified as a key driver of development and job creation. • The Ghanaian government has identified Public Private Partnerships as the most efficient means of plugging the infrastructure deficit that exists in this middle-income country. • As part of this broader initiative, the Accra-Takoradi road is a very important project for the country. This is because the Takoradi port, the second largest seaport in the Greater Accra Region, serves about 35% of all sea freight into Ghana and undertakes exports of cocoa, timber, bauxite and manganese. The road will unlock further economic potential in the port. • As of 2013, the Ghanaian government has taken steps to determine the feasibility and design of the project.Page 19Organisation: KK Plastic Waste Management Project description: Redesigning the business model to turn waste into revenue • Rasool and Ahmed Khan were faced with a challenge. They had been running a successful plastic bag manufacturing business, when they were faced with a possible ban on all plastic bags in the city of Karnataka (India). • The brothers had been intrigued by the possibility of plastic bags being used as an input for road tar. With advice from experts at Bangalore University, they started with pothole repair, using a mix of plastic, tar, stones and aggregate. The new formula was found to be both effective and cost efficient. • Soon the plastic manufacturers were reborn as KK Waste Management. They were awarded a patent and the backing of the Central Roads Research Institute in Dehli. • The company has also boosted the livelihood of traditional kabaadiwalas (waste collectors) and rag pickers, who are paid INR6/kilo for the waste they collect from homes and streets.Page 2010Organisation(s):Lafarge and WWF global partnershipProject description:Partnering for sustainable development•The partnership has run from 2000-2013 (due for renewal thisyear), and is based on the guiding principles of: a collaborativerelationship, ongoing dialogue and mutual trust, leading to jointlydefined goals. The WWF is seen to be the “critical friend” in thisrelationship.•Key areas addressed are: Climate change; Persistent pollutants;Water management; Biodiversity; Sustainable construction•Local operations are empowered to act, linking with nationalPage 21。
Method We devised a simple tool which enabled staff to state what they wanted to “Stop,Start and Keep ”within the services they provided.Discussion This tool was used in an “away day ”style environ-ment,the whole team where engaged in the process and the use of the tool elicited themes from the team in relation to the ques-tions asked,and enabled the team to develop a plan for future developments and discuss key areas of concern.There was an over arching theme related to maintaining qual-ity which underpinned all such developments and a desire to ensure the quality of care patients received was not adversely affected.The use of the tool acted as a bench mark to where weare now and where we wanted to be,and enables the team to review progress,its impact and celebrate success.Conclusion The use of this tool enabled the team to feel engaged and contribute to the development of new ideas and ways of working in challenging times.The process is fluid and enables teams the opportunity to revisit and review and addressissues and developments.P63FIT FOR THE FUTURE ….EMPOWERING AN ORGANISATION THROUGH STRATEGY DELIVERY Roslyn Neely.Children's Hospice Association Scotland,Edinburgh,UK 10.1136/bmjspcare-2013-000591.85Background The organisation has created a visionary strategy toposition them as an influential,leading paediatric palliative care provider in Scotland,the UK and beyond.In creating this,there was an opportunity to truly engage with all those involved in the organisation;reflecting visions and hopes for the future through collaboration and consultation.Children,young people and families using the services;trustees,staff and volunteers were consulted through a series of focus groups,externally facili-tated to maximise objectivity.This was the starting point for a dynamic ongoing strategic planning process to ensure the organi-sation is in a strong position to meet the changing needs of babies,children,young people and their families in a changing political and financial landscape.Method A number of sessions were held to explore what thefuture might hold for the organisation over the next ten years.This has included exploring the changing needs of the children,young people and families who will use the service;considering new ways of delivering care,skill mix review,the hospice envi-ronment,income and expenditure projections,the political land-scape,policy and partnership working with statutory and voluntary organisations.Outcomes T wo years on and the resulting strategic plan is deliv-ering measurable outcomes which are positively impacting on the care and support being given to families.The organisation has also influenced the development of a Framework for the Delivery of Palliative Care for Children and Young People (2013).Staff,volunteers and service-users are motivated,guided and empowered by the plan.The plan has raised awareness ofthe organisation within health and local authority networks,resulting in increased referrals and funding.P64FINANCIAL PLANNING FOR UNCERTAINTY Alison Ryan,Sheena Keep.Weldmar Hospicecare Trust,Dorchester,United Kingdom 10.1136/bmjspcare-2013-000591.86Introduction In common with other independent hospices,Weldmar Hospicecare T rust faces considerable uncertainty over the size and nature of future income.This paper describes the financial modelling which allows us to make sound financial plans despite that uncertainty.Aims T o create an understanding of our complex finances so we can focus on the most impactful income generation,control expenditure and use our Balance Sheet strength to create a future where we are no longer dependent on any one source of income.Approach used•analysis of expenditure and income steams by type and cost centre (80+budget lines).•Application of differential growth/cost pressureassumptions to each line on an Excel model which allows assumptions to be changed producing differentresults.Outcomes this command of our finances has allowed us to:•make budget adjustments in the context of securinglong term strength,•to manage sudden unforeseen changes (such as 90%failure of legacy income in one year)without makingdamaging short term cuts,•to distribute resources to staff via pay in a way whichis sustainable and transparent and affordable,•to invest in income raising possibilities even while run-ning planned £1million deficits.Our model shows that in four years ’time we will have gener-ated sufficient surplus to minimise the impact of loss or reduc-tion of NHS income should competitive tendering produce such a result.It provides a clear guide to managers on how service development can,or cannot,be afforded.Application to hospice practice Hospices have complex and unpredictable income streams –NHS,trading,legacies,dona-tions,investment and relatively fixed costs –largely staffing.Without a long term view,short term reactions to financial hia-tus can lead to unnecessary curtailment of services,loss of opportunity and lowered morale.This model minimises those problems.P65DEVELOPING A CULTURE OF GOOD LEADERSHIP AND MANAGEMENTLynn Kelly,Stephen Greenhalgh.St Catherine's Hospice,Preston,United Kingdom 10.1136/bmjspcare-2013-000591.87Background•Little interaction between managers across different directorates•No sense of ‘team ’amongst managers•Lack of consistent approach and varying degrees of management experienceAim•Set standard for leadership &management amongstmiddle managers•Raise confidence of managers in dealing with staffperformance•Develop team working across departments•Enable managers to contribute to and deliver the Hos-pice 5year planApproach Used A32SPCare 2013;3(Suppl 1):A1–A74 on December 24, 2023 by guest. Protected by copyright./BMJ Support Palliat Care: first published as 10.1136/bmjspcare-2013-000591.86 on 1 October 2013. Downloaded from。
Security Council 安全理事会UNPKF(United Nations Peace-Keeping Force) 联合国维持和平部队GATT(General Agreement on Tariffs and Trade) 关税及贸易总协定ILO(International Labour Organization) 国际劳工组织FAO(Food and Agriculture Organization) 联合国粮农组织UNESCO(United Nations Educational, Scientific, and Cultural Organizatoin)联合国教科文组织WHO(World Health Organization) 世界卫生组织IMF(International Monetary Fund) 国际货币基金组织IBRD(International Bank for Reconstruction and Development) 国际复兴开发银行IMCO(Inter-Governmental Maritime Consultative Organizaton) 政府间海事协商组织IAEA(International Atomic Energy Agency) 国际原子能组织Director General: Mahamed ElbaradeiUNICEF(United Nations Children's Fund) 联合国儿童基金会UNHCR(Office of the United Nations High Commissioner for Refugees)联合国难民事务高级专员办事处commissioner Ruud Lubbers国际刑警组织ICPO国际贸易组织WTO国际刑事法院(InternationalCriminalCourt--ICC)国际劳工组织国际劳工组织（International Labor Organization——ILO）国际移民组织(International Organization for Migration――I0M)亚太经济合作组织（Asia-Pacific Economic Cooperation，简称APEC国际开发协会IDA世界旅游组织(World Tourism Organization，缩写：WTO)国际航空运输协会(International Air Transport Association -- IATA)国际货币基金组织（英语：International Monetary Fund，简称：IMF）世界卫生组织（World Health Organization简称WHO国际足球联合会:(International Federation of Association Football)缩写:(FIFA)国际科学理事会(International Council for Science，简称ICSU国际奥林匹克委员会IOC国际军事体育理事会（International Military Sports Council, CISM）国际新闻工作者联合会(International Federation of Journalists -- IFJ)国际大学协会(International Association of Universities -- IAU)国际新闻电影协会（International Newsreel and News Film Association －－INNA）国际自然及自然资源保护联盟IUCN国际志愿服务协调委员会(Coordinating Committee for International Voluntary Service -- CCIVS红十字国际委员会ICRC国际反贪局联合会International Association of Anti-Corruption Authorities (IAACA)世界知识产权组织（World Intellectual Property Organisation，简称WIPO）世界动物卫生组织(Office International Des Epizooties，OIE)政治类：1、联合国（United Nation简称UN）理由：世界上最大的国际组织，某种意义上的"世界政府"2、北大西洋公约组织（North Atlantic Treaty Organization简称NATO）理由：势力范围越来越大，联合国的有力竞争者3、欧洲联盟（European Union简称EU）理由：欧洲一统的载体，大同世界的试验田经济类：4、世界贸易组织（World Trade Organization简称WTO）理由：相互依赖理论的典型和象征5、国际货币基金组织（International Monetary Fund简称IMF）理由：经济领域的联合国6、世界银行（World Bank简称WB）理由：提供全世界的发展动力7、石油输出国组织（Organization of Petroleum Exporting Countries简称OPEC）理由：1973年的事件已经证明了它的力量和重要性教科文卫类：8、国际原子能机构（International Atomic Energy Agency简称IAEA）理由："核"，世界越来越关注的议题9、世界卫生组织（World Health Organization简称WHO）理由：人类的生存和健康，一个基础和永远不会过时的领域10、国际奥林匹克委员会（International Olympic Committee简称IOC）世界国际组织日常生活知识2009-12-27 16:24:36 阅读6 评论0 字号：大中小国际标准化组织ISO世界贸易组织WTO国际货币基金组织IMF世界银行IBRD各国议会联盟（简称“议联”，Inter－Parliamentary Union －－IPU）总部瑞士日内瓦伊斯兰会议组织(Organization of the Islamic Conference -- OIC) 总部沙特阿拉伯吉达裁军谈判会议(Conference on Disarmament -- CD)总部瑞士日内瓦阿拉伯国家联盟League of Arab States 总部在埃及开罗非洲统一组织（简称“非统组织”，Organization of African Unity -- OAU）总部埃塞俄比亚亚地斯亚贝巴北大西洋公约组织（North Atlantic Treaty Organization -- NATO）总部比利时布鲁塞尔欧洲委员会European Communists EU总部法国斯特拉斯堡美洲国家组织(Organization of American States -- OAS；Organizacion de los Estados Americanos -- OEA)总部美国华盛顿国际铁路联盟Union Internationale des Chemins de fer，缩写UIC，总部法国巴黎石油输出国组织Organization of the Petroleum Exporting Countries，OPEC 总部奥地利维也纳欧洲共同体European Communities 总部比利时布鲁塞尔拉丁美洲经济体系Latin American Economic System，LAES总部委内瑞拉加拉加斯国际红十字会International Committee of the Red Cross，ICRC 总部瑞士日内瓦国际标准化组织international standards organization,ISO总部瑞士日内瓦世界贸易组织（简称“世贸组织”，World Trade Organization -- WTO）总部设在瑞士日内瓦莱蒙湖畔世界旅游组织(World Tourism Organization) 总部设在西班牙首都马德里国际劳工组织(International Labor Organization -- ILO) 总部设在瑞士日内瓦联合国粮食及农业组织(简称“粮农组织”，Food and Agriculture Organization of the United Nations -- FAO) 总部设在意大利罗马联合国教育、科学及文化组织(United Nations Educational, Scientific and Cultural Organization -- UNESCO) 。
service organization control reports -回复什么是Service Organization Control报告（SOC）？Service Organization Control（SOC）报告是由美国会计师事务所（CPA）提供的一种可信度较高的报告，用于对服务机构的内部控制制度进行审计和评估。
这些机构可能是云计算服务提供商、第三方支付处理商、数据中心和其他提供重要服务的组织。
SOC报告帮助用户了解、评估和监督这些机构的风险管理和控制操作。
SOC报告分为三个类型：SOC 1、SOC 2和SOC 3。
社会组织通常根据其业务需求和与客户之间的协议要求选择适合的报告类型。
SOC 1报告：SOC 1报告是基于美国审计准则发展而来，用于评估服务机构的财务报表的控制效能。
这些报告是由美国会计师事务所根据SSAE 18（Statement on Standards for Attestation Engagements）开展的外部审计。
SOC 2报告：SOC 2报告是基于美国审计准则和互联网工程工作组（IETF）的隐私框架发展而来。
它主要用于评估服务机构的客户数据隐私和数据安全性控制。
SOC 3报告：SOC 3报告是SOC 2报告的简化版本，可以向公众发布。
它提供了对服务机构控制环境的一般描述，但不包括具体的细节。
SOC报告的编制通常需要参考相关的控制目标和控制目标的成熟度。
这些目标可以基于国际通用的框架，如控制目标框架（COSO）或国际标准化组织（ISO）的信息安全管理系统标准。
编制SOC报告的过程包括以下步骤：1. 确定报告范围：确定需要评估和审计的服务机构在报告中应该包括哪些控制目标和控制活动。
2. 设计测试程序：根据相关控制目标和控制活动，设计测试程序来评估服务机构的内部控制的有效性。
3. 数据收集和测试：收集相关数据并进行测试，以确定控制目标和控制活动是否存在并有效。
DEVELOPMENT REPORT – April 22, 2002: UN Report on AgingBy Jill MossThis is the VOA Special English Development Report.The number of people over age sixty is expected to increase two times during the next fifty years. A new United Nations population study says the percentage of older people in the world is rising quickly.Today, one of every ten people is over age sixty. By the middle of the next century, onein five people in the world will be sixty years old or older. That will be almost two-thousand-million people. This means there will be more older people in the world thanchildren. Experts say many developing countries do not have the social services to helpincreasing numbers of older people.Joseph Chamie (SHAM-ee) heads the U-N office on population. He says that theaverage length of time a person is expected to live increased by about twenty yearsduring the last half of the twentieth century.The current life expectancy is sixty-six years. The oldest of the old people are also living longer. Mister Chamie says that twelve percent of older people are eighty years old or older.Mister Chamie says the world’s population is getting older because death rates and birth rates have decreased. He says the reduction in these rates has been a great success. The U-N study also found that women still live longer than men in all but two countries – Pakistan and Bangladesh. For every one-hundred women in the world age sixty or over, there are only eighty-one men.The results of the study were discussed at the U-N Second World Assembly on Aging in Madrid, Spain, earlier this month. During the meeting, delegates from one-hundred-sixty countries agreed on a plan to improve the lives of old people. The measure deals with such issues as education, work, retirement guarantees, housing, health care and the rights of older women.U-N officials believe the aging of the world’s population will require a change indevelopment aid. They say future aid should meet the needs of older people. In addition,officials say that older people in developing countries usually do not enjoy retirement. Instead,they often face poor living conditions and poor health. The officials say a system other than thefamily should be established in developing counties to care for older people.This VOA Special English Development Report was written by Jill Moss.Email this article to a friendPrinter Friendly Version。
