8D_Guideline

Appendix A GUIDE TO PREPARE INTERNSHIP REPORT1. INTRODUCTIONThis guideline is to assist students who are undergoing an Internship to prepare their final report.2. FORMAT OF THE REPORT2.1 The report is to be written in English and typed on single-sided A4paper, using 1.5 line spacing.2.2 Use Arial 12 font size. Font size for charts, graphs and tables mayvary according to format and space.2.3 Page layout for each page of the report is as shown below (1 inch =2.54 cm).2.4 Page number must be centered at the bottom of the page.2.5 The length of the report must be between 5,000 -7,000 words only.except with permission of School Supervisor.2.6 Illustrated materials should be of the original size. However if thematerial is bigger than A4, a reduced size is acceptable. Black, whiteand colour photographs and photostated copies are also accepted.2.7 Diagrams, charts and photographs must have titles/captions.Acknowledge the source of materials.2.8 Each report must contain:a. Title (ensure that the title is short and interesting)b. Acknowledgement abstract of not more than 200 wordsc. Table of contentd. List of tablese. List of figuresf. List of abbreviationsThe preface section (b - g) must be numbered in roman numerals and small caps (ii, iii, and so on).h. Outline of the report is as follows:3. SUBMISSION3.1 Student must submitthe Log Book and Report toUNIRAZAK within 1week after the end of the Internship placement.3.2 The Report will not be accepted without student‟s signature ondeclaration of originality of work.3.3 Delay in submission of the report is not allowed except underunforeseen circumstances where permission from the appropriateDean is required.3.4 Student is deemed to have failed the Internship placement if thereport is not submitted on time.4. REFERENCINGUse the Harvard Style author-date system for referencing or to quote within your written text and to list the REFERENCES used. Other systems can also be used consistently throughout with the permission of your supervisor.4.1 Referencing within the textAll references and quotes used in the text must be shown in thesame place where it is done.Example 1: Reference with One (1) AuthorAccording to Shaw (2011, p.318) not all instances of nepotism raiseserious moral concerns, as in a firm of family operation which has itspurpose of providing work for family members.orNot all instances of nepotism raise serious moral concerns, as in afirm of family operation which has its purpose of providing work forfamily members (Shaw 2011, p.318) .Note: Given there are references/quotes from the same authorwithin the same year, add alphabets in small letters next to the year;for example Nafziger (1997a, p. 317), Nafziger (1997b, p. 15). Bothreferences must be listed in the REFERENCES.Example 2: Reference with Two to Three (2 to 3) AuthorsThiroux and Kraseman (2009, p.400) claim that as we have movedout of crowded cities into the countryside nearby and createdsuburbs, we have eliminated more and more of the naturalNote: The same referencing can be done by placing the name ofthe authors at the end of the statement as per Example 1 above.Example 3: Reference with Four (4) or more AuthorsAkintoye et al. (2001, p. 2) defined private financing initiative (PFI)as public service delivery in the form of public-private partnership(PPP) where the responsibility to provide public service such astransportation, recreation, sewerage etc. is transferred from thepublic sector to the private sector for a stipulated period.Note: The name of the authors can also be placed at the end ofthe statement as per Example 1 above. However, all the namesmust be shown in a sequence like in Section 4.3(iii).4.2 Quotation within TextThe same format for Section 4(1) above can be used when usingquotations from any authors, but the symbol “....” may be used in thequotation used, and the page number from of the original quote mustbe shown after the year of publication. Quotes are commonly usedwhen a term or concepts is unique and is cumbersome to betranslated into the language you are using.Example: Quotation from One AuthorStatistics indicate that women and minorities play an unequal role inthe work world as theytend to be clustered in poorer-paying jobssuch as librarians, nurses, school teachers, secretaries, which is consistent with the so-called “pink-collar” occupations, which lead usto good reasons to believe that job discrimination certainly exists(Shaw 2011, p.427-428).Quotations such as the following should be indented on both sidesand reduced to font size 10.Sekaran (2000, p. 204) stressed that:“… use of better instruments will ensure more accurateresults, which in turn will enhance the scientific quality ofthe research. Hence in some way we need to assess the“goodness” of the measures developed. That is, we needto be reasonably sure that the instruments … indeedmeasure the variables they are supposed to, and that theymeasu re them accurately.”4.3 Listing References/QuotationsAny reference or quote used in your report must be listed in the REFERENCES. The references must be listed in alphabetical order according to the name of the first author.(i) Article in a JournalNelson, R (2008)‟ What Enables Rapid Economic progress:What are the Needed Institutions?‟ Reearch Policy, vol. 37 no.1pp.9-21(ii) BookNafziger, W.E. 1997, The economics of developingcountries,(3rd ed.), Prentice-Hall International Inc., New Jersey.(iii) Chapter in a BookAkintoye, A., Beck, M., Hardcastle, C., Chinyio, E. &Asenova,D. 2001, …Risks in Private Finance Initiative Projects, inMontanheiro, L. &Spiering, M. (eds.), Public and Private SectorPartnerships: The Enterprise Governance, Sheffield HallamUniversity Press, U.K.(iv) Conference/Seminar ProceedingsNarayanan, S., Lai, Y.W. &Cheah, K.G. 1993, …Transfer oftechnology revisited: Evidence from the electronics andelectrical sector in Penang‟, Paper presented at the MIERNational Outlook Conference, Kuala Lumpur, Malaysia, 16-19April 1993.(v) ProceedingNarayanan, S., Lai, Y.W. &Cheah, K.G. 1993, …Transfer oftechnology revisited: Evidence from the electronics andelectrical sector in Penang‟ Prosiding MIER National OutlookConference, Kuala Lumpur, Malaysia, pp. 1-17.(vi) Project Paper/Graduation Exercise/Dissertation/Thesis Tsao, Y. 1982, …Growth and productivity in Singapore: A supplyside analysis‟, Ph.D Dissertation, Harvard University, USA.(vii) Internet SourcesWorld Health Organization 2001, ‘Occupational and communitynoise’, www.who.int/mediacentre/factsheets/ fs258/en(Accessed 5 March 2007).APPENDIX B INTERNSHIP PLACEMENT AT XXXX ORGANIZATIONNAMESemesterXXXX/XXXXINTERNSHIP PLACEMENT AT XXXX ORGANIZATIONNAME(MATRIC NUMBER)INTERNSHIP PLACEMENT REPORTSubmitted to UniversitiTun Abdul Razakxxxx/xxxxDECLARATION OF ORIGINALITY OF WORKI confirm that thisInternship placement Report is my own work, except the information, excerpts and references used have been acknowledged. I also admit that the contents of the Report are original and have not been submittedto UniversitiTun Abdul Razak or other institutions for any other purposes.I am solely responsible forthe contents of thisReport,UniversitiTun Abdul Razakshall be absolved from any form of legal actions arising from this research.Signature: .........................................................................Name: ..........................................................................Matric No.: ..........................................................................Date: ..........................................................................CONTENTSSUBJECT PAGE DECLARATION ACKNOWLEDGEMENTABSTRACTLIST OF TABLES LIST OF DIAGRAMS LIST OF ABBREVIATIONS CHAPTER 1INTRODUCTION TO INTERNSHIP PLACEMENT1.1 Foreword1.2 Report Objective1.3 Report MethodologyCHAPTER 2ORGANIZATIONAL BACKGROUND2.1 Organization‟s Background2.2 Mission2.3 Corporate Culture2.4 People‟s Culture2.5 Objective and Functions2.6 Role of Branch Unit2.7 Branch Management Organization2.8 Service ProvidedCHAPTER 3RELATED THEORY COMMENTSCHAPTER 4THEORY APPLICATION IN INTERNSHIP4.2 Role and Tasks in organization4.3 Review Achievement of Internship4.4 Problems and Overcoming MethodsCHAPTER 5CONCLUSION AND RECOMMENDATIONREFERENCES APPENDIX LIST OF TABLESLIST OF DIAGRAMLIST OF ABBREVIATIONS。

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Example - When measuring top box on a 5 point scale for customer satisfaction, the bottom 4 boxes are used to determine the HPD (e.g., a top box result of 55% equals a bottom 4 box result of 45% which would be the historical proportion defective). 例子——用5分制的5分表示顾客满意度的 时候,1-4分就用于确定历史缺陷比率(例
Sample Size Calculator 抽样规模计算方法
Definitions 定义
Population Size 群体规模
Population Size: Is the complete count of an occurance within the group you would like to 318 sample. 群体规模:是你要抽样的群组中一个事件的总数. 群体规模 Historical Proportion Defective (HPD): Is the percent of defects from historical performance. A defect is any incident outside a defined 8.0% performance threshold. 历史缺陷比例( 历史缺陷比例(HPD):是历史绩效中缺陷的百分 比.缺陷是指确定的绩效极限范围之外的所有情况 . Precision: Is the statistical plus/minus band around the sample result. This is also often 1.50% referred to as Confidence Interval. 精确度:是抽样结果的+/-统计范围.也被称为置 精确度 信区间. Degree of Confidence: Is how often a percentage of the sample falls within the 95% confidence interval. 置信度:是抽样的百分比处于置信区间范围内的次 置信度 数. Sample Size: The number of observations required based on the defined criteria to have a 254 statistically valid Sample of the Population. 抽样规模:基于已定义的标准以获得统计上有效的 抽样规模portion Defective 历史缺陷比率

Guidelines佚名【期刊名称】《Asian Agricultural Research》【年(卷),期】2022(14)5【摘要】Journal Customer services,For ordering information,claims and any enquiry concerning your journal subscription please go to contact your nearest office.America:Email:uschinamedia@yahoo,comTel:4006762388-8991189058 Fax:401-941-5829 Europe,Middle East,Africa and AsiaPacific:Email:**************;****************;**************** Tel:+86-551-65148112 Annual subscription rate(12 issues):US$300.【总页数】1页(PF0003)【正文语种】中文【中图分类】R24【相关文献】1.Introduction of a Japan Concrete Institute Guideline： Practical Guideline for Investigation, Repair and Strengthening of Cracked Concrete Structures2.Introduction of a JCl Guideline： Practical Guideline for Investigation, Repair and Strengthening of Cracked Concrete Structures3.2018 Chinese Guidelines for Prevention and Treatment of Hypertension—A report of the Revision Committee of Chinese Guidelines for Prevention and Treatment of Hypertension4.The bold sedentarybehavior recommendations in the new Canadian guidelines: are they evidence-based? Response to "Sedentary Behavior Research Network members support new Canadian 24-Hour Movement Guideline recommendations"5.Clinical practice guidelines for hepatocellular carcinoma:the first evidence based guidelines from Japan因版权原因，仅展示原文概要，查看原文内容请购买。

WHO《数据完整性指南》-2021（中英⽂对照版）3⽉29⽇，WHO发布了第 55 届药物制剂规范专家委员会（ECSPP）技术报告TRS No.1033，其中包含新的《数据完整性指南》，翻译如下，分享给⼤家！Guideline on data integrity数据完整性指南1. Introduction and background介绍和背景1.1. In recent years, the number ofobservations made regarding the integrity of data, documentation and recordmanagement practices during inspections of good manufacturingpractice (GMP) (2),good clinical practice (GCP), good laboratory practice (GLP) and GoodTrade andDistribution Practices (GTDP) have been increasing. The possible causes forthismay include近年来，在对良好⽣产规范(GMP)(2)、良好临床规范(GCP)、良好实验室规范(GLP)和良好贸易和分销规范(GTDP)的检查过程中，对数据完整性、⽂件和记录管理规范的缺陷数量持续增加。

可能的原因包括：(ⅰ) reliance on inadequate human practices;依赖于不适当的⼈员操作;(ⅱ)poorly defined procedures;规定糟糕的规程(ⅲ)resource constraints;资源限制(ⅳ) the use of computerized systems that are not capable of meetingregulatory requirements orare inappropriately managed and validated (3, 4);使⽤不满⾜法规要求，或管理/验证不当的计算机系统(3,4);(ⅴ) inappropriate and inadequate control of data flow; and不适当和不充分的数据流控制;和(ⅵ)failure to adequately review and manage original data and records.未能充分审核和管理原始数据和记录。

Overview
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标准用英语怎么说Standard, in English, refers to a set of criteria or guidelines that are established and accepted as the norm for a certain activity, process, or product. Standards are essential for ensuring consistency, quality, and safety in various fields, including industry, technology, and education. In this document, we will explore the different ways to express the concept of "standard" in English.The most common translation of "标准" in English is "standard." This term is widely used in various contexts to denote a level of quality, performance, or expectation. For example, we often hear phrases like "industry standard," "international standard," or "quality standard," which all convey the idea of a benchmark or norm that is widely recognized and accepted.In addition to "standard," there are several other English expressions that can be used to convey similar meanings. For instance, "norm" is another word that is often used interchangeably with "standard." It refers to a standard or pattern of behavior that is typical or expected within a particular group or society. Similarly, "benchmark" is a term that is frequently used to describe a point of reference against which things can be compared or assessed.Furthermore, the term "criteria" is used to refer to a set of standards or rules by which something can be judged or evaluated. For example, when we talk about the selection criteria for a job or the eligibility criteria for a scholarship, we are referring to the specific standards or requirements that need to be met.Moreover, the word "guideline" is often used to denote a set of recommendations or instructions that are intended to help people achieve a certain standard or level of performance. Guidelines are commonly used in fields such as healthcare, education, and design to ensure that best practices are followed.Another term that is closely related to the concept of "standard" is "protocol." In the context of technology and communication, a protocol refers to a set of rules orprocedures for transmitting data between electronic devices. Similarly, in the field of diplomacy and international relations, a protocol refers to the formal rules of etiquette and behavior that govern official ceremonies and meetings.It is important to note that while these terms are often used interchangeably, they may have slightly different connotations or applications in specific contexts. Therefore, it is essential to consider the nuances of each term and use them appropriately to convey the intended meaning.In conclusion, the concept of "standard" can be expressed in English through various terms such as "norm," "benchmark," "criteria," "guideline," and "protocol." Each of these terms has its own unique nuances and applications, and it is important to use them accurately and appropriately in different contexts. By understanding the various ways to express the concept of "standard" in English, we can effectively communicate and uphold the principles of consistency, quality, and safety in our professional and personal endeavors.。

EDIELECTRONIC DATA INTERCHANGE820 PAYMENT ORDER /ADVICE REMITTANCEIMPLEMENTATION GUIDELINE__________________________________ USING ASC X12 TRANSACTION SET 820004010VERSION1999MAYBNSF EDI820 IMPLEMENTATION GUIDE__________________________________________________________________Table of ContentsIntroduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Payment Order/Remittance Advice Processing . . . . . . . . . . . . . . . . . . 4 EDI Functional Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . 4 The Transaction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Segment ID Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Data Element Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Data Element Requirement Designator . . . . . . . . . . . . . . . . . . . . . . 6 Data Element Length . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Sample 820 . . . (Waybill Number) . . . . . . . . . . . . . . . . . . . . . . . . . 7 Sample 820 . . . (Freight Bill Number) . . . . . . . . . . . . . . . . . . . . . . . 8 Segments and Data Elements:GS Functional Group Header . . . . . . . . . . . . . . . . . . . 9ST Transaction Set Header . . . . . . . . . . . . . . . . . . . . 11BPR Beginning Segment forPayment Order/Remittance Advice . . . . . . . . . 12 TRN Trace . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14REF Reference Identification . . . . . . . . . . . . . . . . . . . 15DTM Date/Time Reference . . . . . . . . . . . . . . . . . . . . . 16N1 Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17ENT Entity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Advice Accounts ReceivableRemittanceRMROpen Item . . . . . . . . . . . . . . . . . . . . . . . . 19 REF Reference Numbers . . . . . . . . . . . . . . . . . . . . . . 20DTM Date/Time Reference . . . . . . . . . . . . . . . . . . . . . 21SE Transaction Set Trailer . . . . . . . . . . . . . . . . . . . . 22GE Functional Group Trailer . . . . . . . . . . . . . . . . . . . 23BNSF EDI820 IMPLEMENTATION GUIDE__________________________________________________________________ IntroductionTransaction Set 820: Payment Order/Remittance AdviceThe 820 standard provides the format and establishes the data content of the PaymentOrder/Remittance advice transaction set within the context of an Electronic Data Interchange (EDI) environment. This transaction set is used to transmit remittance and/or payment information to a bank with instructions to begin funds transfer. The bank subsequently passes the funds transfer request to BNSF's bank along with the 820 detail. At settlement, the Railroad's bank passes the 820 to Burlington Northern Santa Fe Railroad.Using the ASC X12 820 transaction set to electronically transmit data between business partners allows for consistent interpretation of payment information and reduces the chances of interpretive and data entry errors.Burlington Northern Santa Fe will accept the Payment Order/Remittance Advice information published by DISA for ASC X12. The following guidelines are all-inclusive and identify unique accounting requirements for use of the ASC X12 820 transaction set when transmitting data to Burlington Northern Santa Fe.To obtain X12 standards and documentation, contact:Data Interchange Standards Association, Inc.1800 Diagonal Road, Suite 200Alexandria, VA 22314-2840703-548-7005orWashington Publishing Company800-972-4334Orders:301-590-9337Phone:__________________________________________________________________ Payment Order/Remittance Advice ProcessingThe general steps in processing 820s electronically are initiated when the customer enters or creates payment order/remittance advice in their computer. This information, or data, is then formatted into the ASC X12 820 transaction set. This formatting may be performed by you, the customer, or your agent. After formatting, the transaction is delivered to your bank. Your bank will initiate funds transfer and pass the 820 to BNSF's bank. Once funds have transferred, BNSF's bank will send the 820 detail. This detail will be used to perform cash application of the identified records to BNSF's accounts receivable system.EDI Functional AcknowledgmentsBNSF will generate a 997 Functional Acknowledgment to our bank in response to the 820 that is received. Depending on your bank's EDI capabilities, you may receive your bank's 997 when you deliver the 820 to them.__________________________________________________________________The TransactionA transaction set is used to describe the electronic transmission of a single document (Payment Order/Remittance Advice, Bill of Lading, etc.) between one company's computer and another company's computer.EDI transactions are defined by segments, and each item within the segment becomes a data element. Segment ID Name, Data Element Type, Requirement Designator, and Length are described below. These identifiers are listed for each Data Element throughout the remainder of this guide. Segment ID Name(Header)SetHeaderTransactionSTGroupHeaderFunctionGSBPR Beginning Segment for Payment Order/Remittance AdviceInstructionNTE Note/SpecialTRN TraceCUR CurrencyReferenceIdentificationREFReferenceDTMDate/TimeNameN1InformationNameAdditionalN2InformationN3AddressLocationGeographicN4Communications ContactPERAdministrativeMethoddeliveryRDMRemittance(Detail)EntityENTNM1 Individual or Organization NameIdentificationReferenceREFAdministrativeCommunications ContactPERReferenceDate/TimeDTMIT1 Baseline Item Data (Invoice)RMR Remittance Advice Accounts Receivable Open Item ReferenceInstructionNote/SpecialNTE(Summary)TrailerSetTransactionSE__________________________________________________________________ Data Element TypeSpecifies the characters that may be used.Nn Numeric N indicates that it is numeric; n indicates decimal place.R Decimal R indicates an optional decimal point for integer values ora required decimal for decimal values. BNSF can acceptpositive and decimal values. Do not send fractions orvalues.negativeID Identifier A specific code taken from a table defined in the DataElement Dictionary such as unit of measure.AN String A series of alpha/numeric characters, such as a company name.DT Date Date expressed as CCYYMMDDTM Time HHMM expressed in 24-hour clock format.Data Element Requirement DesignatorIndicates when this element must be included in an electronic document.M Mandatory The Data Element is required in the Segment.C Conditional The Data Element may be required in the Segment basedisused.elementwhetheronanotherO Optional The Data Element may or may not be used in the Segmentat the option of the user.Data Element LengthThe minimum length and maximum length of the characters in the data element.1/15 Indicates that "1" is the minimum acceptable value andmaximum.theis"15"BNSF EDI820 IMPLEMENTATION GUIDESample 820[SAMPLE: WAYBILL NUMBER IN RMR SEGMENT]GS*RA*CUSTID0001*BNSF*19990101*1530*9102*X*004010ST*820*000000001BPR*C*10000*C*ACH*CTX*01*1234*DA*555*CUSTID0001**01*987*DA*345123*19990101 TRN*1*1001983525REF*CD*1234564114REF*TN*1001983525 (Mandatory if TRN segment is not used)DTM*007*19990101N1*PE*BURLINGTON NORTHERN SANTA FEN1*PR*CUSTOMER NAMEENT*1RMR*WY*123456**2000REF*D0*RATE AUTHORITY*PER ITEM 12121 RATE SHOULD BE $2000 PER CARREF*BM*1001REF*EQ*BNSF456002DTM*095*19990101RMR*WY*999999**5000REF*BM*1002REF*EQ*BNSF458869DTM*095*19990101RMR*WY*999787**3000REF*BM*1003REF*EQ*BNSF458870DTM*095*19990101SE*23*0000000001GE*1*9102__________________________________________________________________ Sample 820[SAMPLE: FREIGHT BILL NUMBER IN RMR SEGMENT]GS*RA*CUSTID0001*BNSF*19990101*1530*9102*X*004010ST*820*000000001BPR*C*10000*C*ACH*CTX*01*1234*DA*555*CUSTID0001**01*987*DA*345123*19990101 TRN*1*1001983525REF*CD*1234564114REF*TN*1001983525 (Mandatory if TRN segment is not used)DTM*007*19990101N1*PE*BURLINGTON NORTHERN SANTA FEN1*PR*CUSTOMER NAMEENT*1RMR*FR*018923888**5000REF*BM*1003DTM*022*19990101RMR*FR*018923889**5000REF*BM*1004DTM*022*19990101SE*16*0000000001GE*1*9102[SAMPLE: FREIGHT BILL NUMBER IN RMR SEGMENT WITH DISPUTED PAYMENT] GS*RA*CUSTID0001*BNSF*19990101*1530*9102*X*004010ST*820*000000001BPR*C*9500*C*ACH*CTX*01*1234*DA*555*CUSTID0001**01*987*DA*345123*19990101 TRN*1*1001983525REF*CD*1234564114REF*TN*1001983525 (Mandatory if TRN segment is not used)DTM*007*19990101N1*PE*BURLINGTON NORTHERN SANTA FEN1*PR*CUSTOMER NAMEENT*1RMR*FR*018923888**4500REF*D0*OTHER*DIVERSION TO DENVERREF*BM*1003DTM*022*19990101RMR*FR*018923889**5000REF*BM*1004DTM*022*19990101SE*17*0000000001GE*1*9102__________________________________________________________________Segment : GS - Functional Group Header Loop : - Level : Functional Group Usage : Mandatory Max Use : 1 Max Length : - Purpose : To indicate the beginning of a functional group and to provide control information.Example :GS*RA*CUSTID0001*BNSF*19990101*1530*9102*X*004010SEG DATA ELEMENT NAME MIN - MAXREQ TYPE CONTENTSGS01 479 Functional ID Code2/2MIDCode identifying a group of application related transaction sets RA=Payment Order/Remittance Advice (820)GS02 142 ApplicationSender's Code 2/15 M AN Code identifying partysending transmission; codes agreed to by trading partnersGS03 124 ApplicationReceiver's Code2/15 M AN Code identifyingreceiving transmission; Codes agreed to by trading partners "BNSF"GS04 373 Date 8/8 M DT Date of transmission;expressed as YYYYMMDDGS05337Time4/8 M TM Time of transmission;expressed as HHMM; expressed in 24-hr clock time (00-23)GS Segment continued on next page__________________________________________________________________GS Segment ContinuedSEG DATAELEMENT NAME MIN-MAXREQ TYPE CONTENTSGS06 28Group ControlNumber 1/9 M N0Assignednumberoriginated &maintained by thesender. The number inthis header must beIdentical to the samedata element in theassociated functionalgroup trailer, GE02.GS07 455ResponsibleAgency Code1/2 M ID "X" only for ASC X12GS08 480Version/ReleaseIndustry IdentifierCode 1/12 M ANSender'stransmissionstandard version004010.__________________________________________________________________Segment : ST - Transaction Set Header Loop : -Level : Header Usage : Mandatory Max Use : 1 Max Length : 17 Purpose : To indicate the start of a transaction set and to assign a control number.Example : ST*820*000000001SEG DATA ELEMENT NAME MIN - MAXREQ TYPE CONTENTSST01143TS ID CODE3/3MID"820" Definition: Payment Order / Remittance AdviceST02 329 TS CONTROL NUMBER 4/9 M AN Sender's messagecontrol number__________________________________________________________________Segment : BPR - Beginning Segment for Payment Order/Remittance AdviceLoop : -Level : Header Usage : Mandatory Max Use : 1 Max Length : 245 Purpose : To indicate the beginning of a Payment Order/Remittance Advice Transaction Set and total payment amount, or to enable related transfer of funds and/or information from payer to payee to occurExample : BPR*C*10000*C*ACH*CTX*01*1234*DA*555* CUSTID0001**01*987*DA*345123*19990101 SEG DATA ELEMENT NAME MIN - MAXREQ TYPE CONTENTSBPR01 305 Transaction Handling Code 1/1 M ID C=Payment accompaniesremittance adviceBPR02 782 Monetary Amount 1/18 M R Total payment amount for allitemsBPR03 478 Credit/Debit Flag Code1/1 M ID C=CreditD=Debit BPR04 591 Payment Method Code 3/3 M ID Instruction to the origin bankon the method of pmt orderbeing transmitted.ACH=Automated Clearing HouseBPR05 812Payment Format Code 1/10 O ID1.CTX=Corporate Trade Exchange (CTX)(ACH)P=(CCD+)(ACH)Optional - helpful if usedBPR06 506 DFI ID Number Qualifier2/2 M ID01=ABA Transit Routing Number.BPR Segment Continued on next page__________________________________________________________________BPR Segment ContinuedSEG DATAELEMENT NAME MIN-MAXREQ TYPE CONTENTSBPR07507DFI ID Number3/12M AN Depository FinancialInstitution (DFI) ID Number.BPR08569Account NumberQualifier Code 1/3O ID Type of Account.DA=Demand DepositBPR09508Account Number1/35C AN Acct Number of Companyoriginating payment..If BPR08 is present, then BPR09is required.BPR10509OriginatingCompany ID 10/10O AN Unique identifier designatingthe company initiating thefunds transfer instructions.First character is one-digitANSI ID code followed by 9-digit ID NumberBPR11510OriginatingCompanySupplementalCode 9/9O AN Code defined between theOriginating Company &Originating DepositoryFinancial Institution thatidentifies the Companyinitiating the transfer.BPR12506DFI ID NumberQualifier 2/2M ID01=ABA Transit RoutingNumber.BPR13507DFI ID Number3/12M AN Depository FinancialInstitution (DFI) ID Number.BPR14569Account NumberQualifier Code 1/3O ID Type of Account.DA=Demand DepositIf BPR14 is present, then BPR15is required.BPR15508Account Number1/35C AN Payee's Account NumberBPR16373PaymentEffective Date 8/8M DT Date expressed asCCYYMMDD__________________________________________________________________Segment : TRN – TraceLoop : - Level : Header Usage : Mandatory Max Use : 1 Max Length : Purpose : To uniquely identify a transaction to an application. The Trace Number identifies the payment.Example : TRN*1*1001983525SEG DATA ELEMENT NAME MIN - MAXREQ TYPE CONTENTSTRN01 481 Trace Type Code 1/2 M ID 1=Current Transaction TraceNumbersTRN02 127 ReferenceNumber1/10MAN Trace Number (with nospaces or punctuation) -provides unique identification for the transactionTRN03 509 Originating Company ID10/10O AN Identifies an organizationTRN04 127 Reference Number1/30OAN Not used by BNSFNote: If Software does not provide for a TRN Segment, then REF01*TN and REF02 asindicated on following page is required.__________________________________________________________________ Segment :REF - Reference IdentificationLoop : -Level :HeaderUsage :Optional-May be required on certain BNSF ProgramsMaxUse :>1MaxLength:120Purpose : To specify identifying informationExample :REF*CD*1234564114SEG DATAELEMENT NAME MIN-MAXREQ TYPE CONTENTSREF01128 Ref ID Qualifier 2/3 M ID CD=BNSF Patron CodeCK=Check NumberTN=Trace NumberREF02 127 Reference ID 1/10 C AN As defined by the Ref IDQualifier.(Required if REF01 is used) REF03 352 Description 1/80 C AN Free form description Note: If TRN Segment is not used, then REF01 TN or CK is required.__________________________________________________________________ Segment :DTM - Date/Time ReferenceLoop : -Level :HeaderUsage :MandatoryMaxUse :>1MaxLength:69Purpose : To specify pertinent dates and timesExample :DTM*007*19990101SEG DATAELEMENT NAME MIN-MAXREQ TYPE CONTENTSDTM01 374 Date/TimeQualifier 3/3 M ID007=EffectiveDTM02 373 Date 8/8 C DTCCYYMMDD DTM03337Time 4/8 C TM HHMM, Time expressed in24-hr clock timeDTM04 623 TimeCode 2/2 O IDCT=CentralTimeET=Eastern TimeMT=Mountain TimePT=Pacific Time__________________________________________________________________Segment :N1 - Name Loop : N1 Repeat: >1 Level : Header Usage : Mandatory Max Use : >1 Max Length : 159 Purpose : To identify a party by type of organization, name and codeExample : N1*PR*CUSTOMER NAME N1*PE*BURLINGTON NORTHERN SANTA FESEG DATA ELEMENT NAME MIN - MAXREQ TYPE CONTENTSN101 98 Entity Identifier Code 2/3 M ID PE=PayeePR=PayerN102 93 Name 1/60 C AN Free Form Name (Required if N101 is used)N103 66 ID CodeQualifier1/2 C ID Not used by BNSF N104 67 ID Code 2/80C AN Not used by BNSF N105 706 EntityRelationship Code2/2 O ID Not used by BNSF N106 98 Entity ID Code2/3OID Not used by BNSFBNSF EDI820 IMPLEMENTATION GUIDE__________________________________________________________________Segment : ENT - EntityLoop : ENT Repeat: >1 Level : Detail Usage : Mandatory Max Use : 1 Max Length : 222 Purpose : To designate the entities which are parties to a transaction and specify a reference meaningful to those entitiesExample : ENT*1 SEG DATA ELEMENT NAME MIN - MAXREQ TYPE CONTENTSENT01 554 Assigned Number 1/6 O N0 Only ENT01 is necessarybecause there is a singleentity communicating with a single entity (sender to receiver)ENT02 98 Entity ID Code2/3C ID Not used by BNSF ENT03 66 ID CodeQualifier1/2 C ID Not used by BNSFENT04 67 ID Code 2/80 C AN Not used by BNSF ENT05 98 Entity ID Code 2/3 C ID Not used by BNSF ENT06 66 ID CodeQualifier1/2 C ID Not used by BNSF ENT07 67 ID Code 2/80 C AN Not used by BNSF ENT08 128 Ref ID Qualifier 2/3 C ID Not used by BNSF ENT09 127 Reference ID1/30CAN Not used by BNSF__________________________________________________________________Segment : RMR - Remittance Advice Accounts Receivable Open Item Loop : ENT/RMR Repeat: >1 Level : Detail Usage : Mandatory Max Use : 1 Max Length : 121 Purpose : To specify the accounts receivable open item(s) to be included in the cash application and to convey the appropriate detailExample : RMR*WY*123456**5000SEG DATA ELEMENT NAME MIN - MAXREQ TYPE CONTENTSRMR01 128 ReferenceIdentification Qualifier2/3 M ID WY=Waybill NumberBM=Bill of Lading Number FR=Freight Bill Number or Miscellaneous Bill Number(See Note Below)RMR02 127 Reference ID 1/30 CAN Reference information asdefined by the Reference ID Qualifier in RMR01 WY=123456RMR03 482 Payment Action Code 2/2OID PO=Payment on AccountSpecifies how the cash is to be appliedRMR04 782.00 MonetaryAmount1/18 M R Amount PaidNote:The preferred qualifier in RMR01 is WY or FR. If WY or FR is notavailable, then BM should be used. IF RMR*WY or RMR*BM is used, then REF*EQ is mandatory.DTM Segment is required in conjunction with RMR01*WY and RMR01*BM.__________________________________________________________________Segment : REF – Reference NumbersLoop : ENT/RMR Level : Detail Usage : Optional Max Use : >1 Max Length : 120 Purpose : To specify identifying informationExample : REF*BM*1001 REF*EQ*BNSF456002 REF*D0*RATE AUTHORITY*RATE SHOULD BE $2000 PER CARSEG DATA ELEMENT NAME MIN - MAXREQ TYPE CONTENTSREF01128 Reference Identification Qualifier 2/3 M ID WY=Waybill NumberBM=Bill of Lading Number EQ=Equipment NumberFR=Freight Bill Number or Miscellaneous Bill Number(See Note 1 Below)D0=Dispute Reason Code(See Note 2 Below)REF02 127 Reference ID 1/30 CAN Reference information asdefined by the Reference ID Qualifier in REF01 BM=1001IDs for D0 (Dispute Reason Code):Equipment Size Origin/Destination OtherRate Authority Service LevelThrough Rate vs Rule 11 WeightREF03 352 Description 1/60 CAN A free form description toclarify the related data elements & their contentNote 1. If Waybill Number or Bill of Lading Number or Freight Bill Number is used in the RMR Segment, then same Number is not needed in the REF Segment. If REF*WY or REF*BM is used, then REF*EQ is mandatory. Note 2. If payment is based on an amount that is different from the amount shown on BNSF’s Freight Bill, use an REF Segment with a D0 qualifier. The REF02 should be one of the Reference IDs listed under Contents. The REF03 is used to provide additional information related to the amount being paid.BNSF EDI820 IMPLEMENTATION GUIDE__________________________________________________________________Segment : DTM - Date/Time ReferenceLoop : ENT/RMR Level : Detail Usage : Optional Max Use : >1 Max Length : 69 Purpose : To specify pertinent dates and timesExample : DTM*095*19990101SEG DATA ELEMENT NAME MIN - MAXREQ TYPE CONTENTSDTM01 374. Date/TimeQualifier 3/3MID 095=Bill of Lading Date orWaybill Date 022=Freight Bill DateDTM02 373 Date8/8 C DT CCYYMMDD__________________________________________________________________Segment : SE - Transaction Set TrailerLoop : - Level : Summary Usage : Mandatory Max Use : 1 Max Length : 24 Purpose : To indicate the end of the transaction set and provide the count of the transmitted segments (including the beginning (ST) and ending (SE) segments) Comment : An (SE) is the last segment of each transaction setExample : SE*18*000000001SEG DATA ELEMENT NAME MIN - MAXREQ TYPE CONTENTS SE01 96 Number of included Segments 1/10MN0 Total number of Segmentsincluded in a transaction set including ST and SE SegmentsSE02 329 Transaction Set Control Number4/9MAN Transaction Set ControlNumber - must be identical to the Transaction Set Control Number in the ST Segment__________________________________________________________________Segment : GE - Functional Group TrailerLoop : - Level : Functional Group Usage : Mandatory Max Use : 1 Max Length : 24 Purpose : To indicate the end of a functional group and to provide control information.Example : GE*1*9102SEG DATA ELEMENT NAME MIN - MAXREQ TYPE CONTENTSGE01 97 Number of Transaction Sets Included 1/6MN0 Total number of transactionsets included in the functional group terminated by the trailer containing this data elementGE02 28 Group Control Number1/9MN0 Assigned number originated& maintained by the sender. This number must be identical to the same data element in the associated functional group header, GS06.。

【H】G P T1-1指导原则编号:化学药物急性毒性研究技术指导原则（第二稿）二OO四年三月一日急性毒性研究技术指导原则目录一、概述 (2)二、基本原则 (3)三、研究内容 (3)四、数据分析及评价 (5)五、名词解释 (6)六、参考文献 (6)七、附录 (7)八、起草说明 (17)九、著者 (20)急性毒性研究技术指导原则一、概述动物急性毒性试验是指动物一次或24小时内多次给予受试物后，一定时间内所产生的毒性反应。

所有拟用于人的药物通常需要进行动物急性毒性试验[1]。

从新药开发的客观规律来看，急性毒性试验处在毒理研究的早期阶段，所获得的信息有助于重复给药毒性试验的剂量选择，初步揭示受试物可能的毒性作用靶器官，同时也会暴露一些迟发的毒性反应。

另外，急性毒性试验的结果有时可用作Ⅰ期临床试验起始剂量选择的参考，并能提供一些与人类急性药物中毒相关的信息[1，2]。

由OECD（Organization of Economic Corporation and Development）于1987提出的动物急性毒性试验称为经典的急性毒性试验[3]，为新药的开发作出了重要贡献。

美国、欧盟、日本为了国际注册要求的统一协调，于1991年召开了第一次人用药品注册技术要求国际协调会（ICH1），对经典急性毒性试验进行了科学、客观的分析与评价，认为经典急性毒性试验存在较大的局限性，有些要求缺乏科学基础。

各方在科学的基础上就急性毒性试验达成了共识：建议采用两种啮齿类动物或一种啮齿类动物加一种非啮齿类动物的严格设计的、单次给药的、逐渐增加剂量的耐受性研究，取代啮齿类动物或非啮齿类动物半数致死量（LD50）测定的要求[4]。

在1997年进行的第二次ICH会议中，又对支持单次给药临床试验的动物急性毒性试验进行了讨论 [5]。

我国在1993年和2001年分别发布了两版有关急性毒性试验的指导原则，在我国的新药研发中发挥了重要作用。

随着我国加入WTO，国产新药进行国际注册成为必然，这种情况下，技术指导原则应首先符合国际注册的要求。

循证依据 国外指南提示，口服磷酸钠对结肠镜检查的总体肠道清洁
度与ＰＥＧ相似，但出于安全性考虑，特别是肾脏损伤的 风险，并不推荐常规使用。从费用-效果比角度比较，磷 酸钠的肠道准备费用要低于ＰＥＧ. 国内一项关于便秘患者口服磷酸钠与ＰＥＧ的肠道准备效 果比较研究表明，磷酸钠组患者肠道清洁度评分优于ＰＥ Ｇ组（０.９６±０.０７比１.５２±０.０８，Ｐ＝０. ０４１），肠道气泡明显少于ＰＥＧ组（１.０４±０.０ ８１.４８±０.０９，Ｐ＝０.０３１），排便总次数多 于ＰＥＧ组（８.９０±０.９７比７.６９±０.９３，Ｐ ＝０.２１９）。 两组患者服药前后血压、心率变化，总体不适程度及不良 反应发生率，药物口感及愿意再服率等差异无统计学意义， 但磷酸钠组患者药物完全服用率高于ＰＥＧ组（９８％比 ９０％，Ｐ＝０.０３４）.认为对于慢性便秘患者，磷酸 钠与标准ＰＥＧ相比是耐受性高且更为有效的肠道清洁剂 .
中国消化内镜诊疗相关肠道 准备指南解读
背景：肠道准备现状
肠道准备质量直接影响消化内镜的诊疗 效果
对操作时间，图像质量，治疗效果都有影响
对肠镜操作的影响
肠道准备不充分导致操作时间增加
■结肠镜操作时间（到达盲肠时间、肠镜撤出时间、整个过程时间）与清肠质量显著相关 ■清肠质量低、高和中者相比结肠镜操作时间增加（到达盲肠时间分别为16.1、11.9、14.4分钟） ■结肠撤出时间分别为11.3、9.8、11.1分钟，整个过程时间分别为27.4、21.7、25.6分钟
观察
肝硬化合并或不合并腹水
肝硬化是急性磷酸盐相关肾病的危险因素之一; 首选聚乙二醇制剂
充血性心力衰竭
纽约分级Ⅲ或Ⅳ级，或左心室射血分数<50％，严禁使用 磷酸钠盐制剂；
首选聚乙二醇制剂

（汽车行业）汽车行业英文缩写OTS=off tooling samples 即全工装状态下非节拍生产条件下制造出来的样件.用于验证产品的设计能力.(用于验证设计出来的产品是否符合客户要求，同时也是对生产工装的验证) 同时OTS也可以叫模具样品，LH 要求汇总书(一个项目的所有资料)TPB 产品技术描述(图纸、技术供货条件等等)DKM 数据控制模型(汽车形状1:1的基准样车)P P认可＝计划认可(决定投入批量生产)B B认可＝采购认可(对生产手段的投资认可)D D认可＝零件生产和供应认可(为零批量)BMG 产品工程性能认可EM 进行首批样件检验的首批样件，首批样件检验也称首批样件认可。

EMPB EMPB＝首批样件检验报告(供货商对其样件检验的文件)2TP 两日生产(供货厂的批量预生产，用来验证批量能力)PVS 生产试制批量0S 零批量(在批量生产条件下的总演习)SF 批量认可(对批量生产的产品认可)EPF (批量供货)计划认可KAF 集团路试验收(质量方面的批量认可)SOP 生产启动(批量生产启动)ME 市场导入(提供给销售商)CAD 计算机辅助设计COP 沿用件(与先前车型通用的零件) CKD 全部拆散SKD 部分拆散HT 自制件KT 外购件(外部供货厂生产的零件)KD 售后服务OTS 用批量生产的模具生产的零件TE 技术开发部PE (合资厂中的)产品工程部TL 技术供货条件TS 产品零件表ZP 检查点ZSB 总成AEKO (产品)改动的控制组织常用英文缩写对照表汽车行业英文缩写(2009-05-06 14:34:33)OSM- Outside of MaterialOTC Over The Counter 非处方药，可在柜台上卖的药PA Program Approvalpallet n. 托盘Passenger Vehicle 乘用车PAT- Program Attributes Team 产品属性小组PDL Product Design LetterPH Proportions&HardpointsPIPC- Percentage of Indexes with Process Capability 能力指数百分比PIST- Percentage of Inspection points Satisfying Tolerance 检测点满意工差百分比PMT- Program Moudle Team 产品模块小组PO Purchase OrderPPAP- Production Part Approval Process 生产件批准程序PPSR Production Preparation Status ReportPQA Process Quality AssurancePR Program ReadinessPre-Launch 试生产price-driven costing 价格引导成本Production Preparation-Final Nissan - PT2/Renault - PP Production Preparation-Initial Nissan - PT1/Renault - PPP3 Production Trial Run 试生产Prototype 样件QFD Quality Funtion Deploy质量功能展开QFTT Quality Functional Task TeamQR- Quality Reject 质量拒收QS Quality StandardRAN Release Authorisation Numberreverse 倒车档RFQ Request For Quotation询价RKD Reverse Knock DownRLQ Receiving Lot QuantityROC Rate of ClimbROI return on investment 报酬率ROP Re-Order PointRTO Required To OperateSAIS Supplier Assessment & Improvement System SC Strategic Confirmation/significant Charac’teristics SDS- System/ Design Specifications 系统/设计说明second gear 二档SFMEA System FMEAShipping Date 出货日、Invoice Date 发票日或On Board Date 装船日Side Windshield 侧窗玻璃SJ Strategic IntentSNP Standard Number of Parts1PP- First Phase of Production Prove-Out 第一次试生产3C Customer(顾客导向)、Competition(竞争导向)、Competence（专长导向）4S Sale, Sparepart零配件, Service, Survey信息反馈5S 整理，整顿，清理，清洁，素养8D- 8 DisciplineABS Anti-lock Braking SystemAIAG 美国汽车联合会ANPQP Alliance New Product Quality ProcedureApportionment 分配APQP Advanced Product Quality PlanBacklite Windshield 后窗玻璃Benchmark Data 样件资料bloodshot adj.充血的, 有血丝的BMW Bavarian Motor WorksSOW- state of work 工作申明SPC Statistical Process ControlSQA Supplier Quality AssuranceSREA- Supplier Request for Engineering Approval 供应商工程设计更改申请ST Surface TranferSTRS Supplier Test Report SystemSubcontractor 分承包商Sunroof Windshield 天窗玻璃SUV Sports Utility VehicleTAG Test Aptitude GraphiqueTCO Total Cost of Ownership 总持有成本TCRA Total Cost Reduction ActivityTGR Things Gone RightTGW Things Gone WorstTM Techinical ManualTPM Total Preventive MaintenanceTTO-Tool Try Out 工装验证UOM Unit Of MeasureVES Vehicle uation SystemVO- Vehicle Operation 主机厂VPP- Vehicle Program Plan 整车项目计划VQA Vehicle Quality AssuranceVTTO- Vendor Tool Try-Out 供应商工装验证WERS- World Wide Engineering Release System WVTA Whole Vehicle Type Approval凹坑concave车床lathe抽查试验spot check test出厂试验delivery test次品defective product调幅amplitude modulation (AM) 调频Frequency Modulation断差offset对讲机interphone法平面normal plane翻车rollover返工re-doing防滑地板no-skid floor仿真emulation副作用side effect改装厂refitting factory隔热板heat shield后围侧板rear wall side cover划痕scratchC.P.M Certified Purchasing manger 认证采购经理人制度CB- Confirmation Build 确认样车制造CC- Change CutOff 设计变更冻结CCSC- critical/significant characteristicCCR Concern & Countermeasure RequestCCT Cross Company TeamCharacteristics Matrix 特性矩阵图COD Cash on Delivery 货到付现预付货款(T/T in advance) CP1- Confirmation Prototype 1st 第一次确认样车CP2- Confirmation Prototype 2nd 第二次确认样车Cpk 过程能力指数Cpk=Zmin/3CPO Complementary Parts OrderCraftsmanship 精致工艺Cross-functional teams 跨功能小组CUV Car-Based Ultility VehicleD1：信息收集；8DD2：建立8D小组；D3：制定临时的围堵行动措施，避免不良品流出；D4：定义和证实根本原因，避免再发；D5：根据基本原因制定永久措施；D6：执行和确认永久措施；D7：预防再发，实施永久措施；D8：认可团队和个人的贡献。

福特汽车公司顾客特殊要求与ISO/TS 16949:2002结合使用根据ISO/TS 16949:2002，“组织”是指已获得ISO/TS 16949:2002注册的制造工厂。

分承包方是指由组织直接签约，向组织提供产品以支持与福特汽车公司签署的合同。

分承包方由组织所雇用，以提供与福特汽车公司合约没有直接相关的服务（如：地面清洁或除草），不会受到ISO/TS 16949:2002中所规定分承包方开发或其它分承包方要求的任何影响。

在本文件中，“组织”一词和“供方”一词可以互换，它们都表示某获得ISO/TS 16949:2002注册的公司（或现场）。

1. 范围ISO/TS 16949:2002和本文件为福特汽车公司的供方定义了最基本的质量体系要求，可代替QS-9000第三版。

2006年12月14日以后，福特汽车公司将不再接受QS-9000注册。

本文件包括了对ISO/TS 16949:2002技术规范的补充公司特殊要求，注册／认证审核的范围必须包括这些补充要求以得到承认，且满足福特汽车公司对供方接受一个被IATF认可和签约的认证机构进行第三方认证的准则。

ISO/TS 16949:2002适用于福特汽车公司供方（生产件、服务件和材料）的制造现场，也适用于生产件的装配厂或向“福特车辆装配工厂”提供材料的厂商。

福特汽车公司的“工装和设备”供方不适合进行ISO/TS 16949:2002注册。

然而在2006年12月14日之前，他们适合QS-9000的“TE补充要求”来进行注册。

半导体供方提出符合本范围的要求，则可以进行ISO/TS 16949:2002注册。

他们也适合进行QS-9000的“半导体业补充要求”的注册。

参见在/sta/网站上，供方质量要求推动小组（Supplier QualityRequirement Task Force, SQRTF）对于QS-9000补充要求的公开信件。

可以经由AIAG网站/获得QS-9000补充要求。

公司里各职位名称的英文缩写公司高层职位的英文缩写:CEO ： Chief Executive Officer 首席执行官CFO ： Chief Financial Officer 首席财务官COO ： Chief Operated Officer 首席运营官CTO ： Chief Technology Officer 首席技术官CIO ： Chief Information Officer 首席信息官CRO ： Chief Risk Officer 首席风险官CEO（Chief Executive Officer），即首席执行官，是美国人在20世纪60年代进行公司治理结构改革创新时的产物，它的出现在某种意义上代表着将原来董事会手中的一些决策权过渡到经营层手中。

在我国，CEO这个概念最早出现在一些网络企业中。

在那里，CEO往往是自封的，也很少有人去研究这一称谓对企业到底意味着什么。

但是，当“CEO”在中国叫得越来越响的时候，我们应该认识到，高层人员称谓的改变不是一件小事，设立CEO职位不应仅仅是对时尚的追赶。

CFO(Chief Financial Officer)意指公司首席财政官或财务总监，是现代公司中最重要、最有价值的顶尖管理职位之一，是掌握着企业的神经系统(财务信息)和血液系统(现金资源)灵魂人物。

做一名成功的CFO需要具备丰富的金融理论知识和实务经验。

公司理财与金融市场交互、项目估价、风险管理、产品研发、战略规划、企业核心竞争力的识别与建立以及洞悉信息技术及电子商务对企业的冲击等自然都是CFO职责范围内的事。

在一个大型公司运作中，CFO是一个穿插在金融市场操作和公司内部财务管理之间的角色。

担当CFO的人才大多是拥有多年在金融市场驰骋经验的人。

在美国，优秀的CFO常常在华尔街做过成功的基金经理人。

COO (chief Operation officer )首席营运官的职责主要是负责公司的日常营运，辅助CEO的工作。

BYD Battery-Box Premium LVSService Guideline and ChecklistVersion 1.0Valid for Premium LVS 4.0 / 8.0 / 12.0 / 16.0 / 20.0 / 24.0LVS 16.0 (4 Modules + PDU - max. 64 Modules in 16 Towers per System)BMU (1 x per System)Make sure to always use the latest version of this service document,available at: Important: The installation and all other kinds of works or measurements in combination with the Battery-Box Premium are only allowed by professional and qualified electricians.This checklist is a shortened assistance for the Battery-Box and does not replace the original manual,which can be found on w /w ww.eft-systems.de/w .au​.Subject to technical modifications;no responsibility is accepted for the accuracy of this information.Attention:Improper handlingCONTENTCONTENT 21. GENERAL STEPS32. ERROR ANALYSIS 42.1 BMU shows no reaction / No LED 42.2 Communication problem with Inverter 52.3 Problem with the Firmware Update / App Configuration 62.4 BMU/BMS LED Event Code (EC)72.5 Be Connect Plus (BCP)82.6 Voltage measurement and undervoltage92.7 Visual Check112.8 Identifying a faulty module113. SERVICE TASKS123.1 BMU Replacement123.2 PDU Replacement123.3 LVS Module Replacement12 SERVICE CHECKLIST AND CONTACT INFORMATION13Make sure to always use the latest version of this service document, available at: ​w Please proceed first with the installation steps by:1. GENERAL STEPSNo. Name Description1 Configuration Check if the configuration is correct. Refer to latest “BYD Battery-Box Premium LVSMinimum Configuration List” (V1.1 or above) available at: ​w Make sure the inverter is configured correctly.2 Correct externalcabling munication to invertera.Depending on the choice of inverter the cable between the BMU portand the inverter must be specially made. Please check thespecifications in the installation manual.b.Recommended CAT5 or higher;c.Check the cables and replace them if necessary2.Groundinga.Battery-Box connected directly to the ground-bus of the house.b.The battery must not be earthed via the inverter! Otherwise,communication problems are possible.3.Ethernet-Cable for Internet (​s trongly recommended!​)4.DC-Ports - Make sure that ​+and ​- ​a re properly connected. (Male DC Connectorpiece required)5.Correct parallel connection cabling if applicable3 Latest FirmwareAlways install / update the ​n ewest Firmware​!Note: If not stated otherwise, wifi password is BYDB-Box4 App Configuration To complete the commissioning, the configuration of the battery via “Be Connect” Appis ​m andatory​!5 Restart After app configuration, please perform a proper restart of the system by switching offthe battery correctly (press LED Button on ​B MU​for 5 sec). Make sure all LEDs of thebattery are completely off. Then follow the correct switch on procedure (see step 6)6 Switch on procedure Correct switch on procedure is important for a correct operation!1.Switch on the fuse between Inverter and Battery (if there is any)2.Switch on the Battery-Box (LED Button on the top ​L VS module​)3.Activate the inverter7 Checking the correctoperation The system runs properly if:- Inverter displays battery SOC correctly- System charges / dischargesNote: ​If you can not complete the commissioning, then turn off the battery before you leave the site and make sure all LEDs are off to avoid a discharge of the battery.2.1 BMU shows no reaction / No LEDLEDs of BMU do not light up, although the battery is ON.2. ERROR ANALYSISPlease refer to the general steps before proceeding, see chapter 1.No. NameDescription8Check correct cable portMake sure that the correct data cable port has been used at the BMU (“BMS” port. Do not mix with “inverter” or “Ethernet” port).9 Unplug Comm CableSometimes might be necessary to unplug the communication cable and plug it back again when the batteries are switched on.10 Replace Comm Cable Try a completely new communication cable between battery and BMU.11Voltage measurement on pin 7&8Measure the voltage of PIN 7 & 8 while the other side of the cable is connected to the IN port of the Battery-Box and while the Battery-Box is powered on. Voltage should be around 50V. If yes: try another BMU (if available). If no: check another cable or try another LVS if multiple batteries are installed in the system..12Only LED faulty?In some rare cases, the LED of the BMU is faulty. To check that: check if there is a WIFI access point of the Battery-Box and check if there are internal LEDs inside the BMU. If so, only the external LED is inactive and a commissioning could still work. 13 Voltage measurement Check voltage of battery. See ​S ection 2.614BMU exchangeOnly if voltage between pin 7&8 are okay, correct comm port is used, voltage seems correct and the cable between the Battery and the BMU was exchanged: Test another BMU, if available.2.2 Communication problem with InverterNo. Name Description15ConfigurationCheck if the configuration is correct. Refer to latest “BYD Battery-Box Premium LVS Minimum Configuration List” (V1.1 or above) available at: Make sure the inverter is configured and working correctly.16 Communication cable- Confirm PIN / Cable Configuration for the specific inverter model (see manual) - Replace the communication cable (min. CAT5!)17 Check terminal resistorMake sure that the terminal resistor is connected to the OUT port of the last battery (the battery with the highest address).Terminal resistor properties: 120 Ω resistor between pin 5 and 618App Configuration and FirmwarePlease check if the App configuration was successful and the Firmware is the most recent one. If there are problems, please refer to ​S ection 2.319Restart the entire system1. Switch off the Inverter2. Switch off the battery (Press button on BMU for 5 seconds until all batteries switch off)3. Wait for 2 Minutes4. Turn on the Battery (button on any battery) and then5. Turn on inverter second20 Further checkingIf problem remains:- Download all data with BCP​ (section 2.5) - Check the inverter- Try by replacing the BMU, if available2.3 Problem with the Firmware Update / App ConfigurationThe Battery Management consists of two components: the BMU and the BMS. The Firmware Update from the App will update the BMU, which will then update the BMS. ​T he BMS update can take up to 30 Minutes until the firmware is updated on the BMS​.No. NameDescription21Correct App and FirmwareMake sure to have the latest App Version (>1.5.1) and Battery Firmware (download inside the App) on your mobile device before connecting the app with the battery WiFi.If the App cannot be installed, or other general Problems occur with the App:-Try with a different mobile device (For Android: min Android version requirement is 4.4. ) -Try with PC Tool BCP (​s ection 2.5​) 22App reports: “Dataconnection busy” / “Data connection failure.” Battery-Box is busy (e.g the battery could be updating the firmware). Please wait 10 minutes and try again.23Close and restart the AppIf the App does not react anymore after some minutes loading during the update process, close (close the program completely) and restart the App. Or try with ​P C Tool BCP (​s ection 2.5​)24BMS Version not updatedThe App will only update the BMU. The BMU will update the BMS, which ​c an take up to 30 minutes​.If the BMS Version is not updated after 30min with stable inverter communication, follow the below Process:1.Update Firmware through the App again2.Restart the systema.Switch off the Inverter first, then switch off the battery second(Press LED for 5 seconds) b.Wait for 2 Minutesc.Turn on the Battery first, then turn on the inverter second3.Wait for 30 Minutes4.Check BMS Firmware Version again with App. If Version is still wrong, dothe update process again (if possible with another mobile device).2.4 BMU/BMS LED Event Code (EC)A constant white LED refers to standby mode. White blinking means charge or discharge.When the battery is initiating, the LED will flash white and blue with an interval time of 0.5 seconds (normal during startup). When the LED flashes blue with an interval time of 1 second it indicates an event code. We start to count when the white LED begins to flash, then we count how many times white and blue LED flashes. (also refer to the manual!)Example: 1xwhite, 6xblue → EC 106 / 1xwhite, 11xblue → EC 111 / 3xwhite, 3xblue → EC 303Most Errors come from a faulty communication line, incorrect app configuration or missing restart after app-configuration. Please go in detail through: ​S ection 2.2 & 2.3Note: if the system is not correctly configured with the app, the event code (EC) might be misleading.EC BMU ECBMSMeasureEC 101 all - Download all data with BCP (especially the historical data)​(section 2.5)If problem remains: replace BMU, if availableEC 102EC 105all- Make sure app-configuration has been completed correctly (especially module quantity!).- Check terminal resistor- replace communication cable ​b etween Battery and BMU- Restart system according to manual. (note: to properly shut down you need to press the buttonon BMU for 5 seconds. Make sure to start the battery before starting the inverter!)- If the problem rem​a ins, check the connection ports of the LVS Module​with the LED white andblue blinking and the module above this one. If all modules show this blinking, check the topmodule first ​(see section 2.7)- Download all data with BCP (especially the historical data)​(section 2.5)- Check if the system works when removing ​t he suspected module​(see section 2.8)If problem remains: replace BMU, if availableEC 103EC 108- Check DC cabling and make sure that the Minimum Configuration is met.- Check the voltage of the batteries with BCP according to ​s ection 2.5 / 2.6- Restart system properly (see ​S tep 19​,section 2.2​; especially make sure that fuse betweenbattery and inverter is closed, if there is a fuse)- Download all data with BCP (especially the historical and cell data)​(section 2.5)- Check if the system works when removing ​t he module with the EC​(see section 2.8)- provide the SN and voltage of the faulty module (see checklist on last page)EC 104 EC 101 - Check DC cabling (is there any short circuit? Fuse between battery and inverter closed?)- Disconnect the battery system from the inverter and restart the battery system alone (batteryisolated), to evaluate if the error is being caused externally (i.e. short circuit in inverter or mppt). Ifthe Event Code remains, the error might be in the battery. If the Event Code has changed, theremight be an error in the inverter side.- Download all data with BCP (especially the historical and cell data)​(section 2.5)- Check if the system works when removing ​t he module with the EC​(see section 2.8)- provide the SN and voltage of all modules with the EC (see checklist on last page)2.5 Be Connect Plus (BCP)Be Connect Plus is a Windows-PC tool. With Be Connect Plus (BCP) you can:-read the battery information, -configure the battery system -update BMU & BMS firmware -Export / download battery logs (From BMU and all BMS)BCP is constantly being improved and updated.​ Make sure to use the latest program version. You can download the latest version of the Tool on / www.eft-systems.de / .au​.For the service analysis, please download and provide the data / logs as described in the program instructions (see PDF manual inside of program ZIP archive).Note: You need a windows computer that will be connected to the battery Wifi.EC 104EC 102 up to EC113(All other than 101)- Download all data with BCP (especially the historical and cell data)​ (section 2.5) - Check the voltage of the batteries according to ​s ection 2.6- Check if the system works when removing ​t he module with the EC​ (see section 2.8)- provide the SN and voltage of the module with the EC (see checklist on last page) EC 106 all- Make sure the inverter is on, configured and working correctly. - Check according to​ section 2.22.6 Voltage measurement and undervoltageAttention: Make sure not to create a short circuit!-You can see the max. and min. cell voltage in the BeConnect App.-You can also get the detailed module and cell voltage in the BCP Program (section 2.5)-or measure it manually according to the below description:To check the voltage on the PDU, the Modules have to be ON and the BMU has to be connected with the PDU! (LEDs on Modules and BMU have to be ON)Please measure at ​P+​and ​P-​according to the below picture:The voltage measured on the PDU is the combination / average voltage of all modules in the tower. This should be around 50 V. If it is not around this value, please measure the voltage of each individual LVS Module by one of the following two possibilities (please note, that you cannot measure the correct voltage in any other way).1.Only put one Module in the tower and measure the voltage according to the above process on the PDU.(Make sure the LVS Module is ON and BMU connected when you measure the voltage on the PDU).2.If the modules cannot be activated, or you cannot get a correct voltage value, the other option tomeasure the voltage in one LVS module is by opening the module according to the below process:To check the voltage, you need to disassemblethe right side of the battery module (the side withthe LED). Then follow the procedure described onthe next page.Attention: Make sure not to create a short circuit!The voltage should be about 50 V.Measure the voltage at the below marked “BAT+” and “BAT-”.Measurement shown here:UndervoltageA Module in which one of the 16 cells has a voltage of <1.5 V is in undervoltage (check with BCP (section 2.5) / BC if possible).- LVS Modules with >45 V should be fine and you can continue to check other points according to this service guideline.- If the module voltage is <40V but the single cell voltage is >1.5V, the battery needs to be charged quickly while avoiding any further discharge. Therefore shutdown the system and search the problem according to the guideline, while the battery is completely off. Also check on the inverter side why the force charge doesn’t work. Do not turn on the battery before making sure the inverter should be able to charge the battery.- If only one module is in undervoltage: remove that one and try commissioning without it (if the remaining modules still comply with the Compatible Inverter List). Otherwise, make sure to avoid further overdischarge. (Turn off the system completely)- If one, or all modules are in undervoltage: Contact the service as stated below and make sure to avoid any further discharge of the battery (Turn off the system completely)When contacting the service, make sure to fill the service checklist completely and add the following information: -Serial Numbers (of the BMU and all (affected) modules)-Individual module voltages of all modules (related to Serialnumber)-If possible: Logs from the battery using BCP (section 2.5) and Screenshots showing the cell voltages-Initial Firmware (FW) Version of the Battery when the UV happened (BMU and BMS)-Detailed description how and why the system reached Undervoltage if known. Information when the system was installed and commissioned and in which circumstance and when the undervoltage happened. If the battery wasnever running before: Why did it never work before, and what was the Batteries status when the battery was left (on / off / LED).-Inverter Model, Serial Number and Inverter Logs-Access to Inverter portal (add ​i******************​and tell us the name of the system in the portal)2.7 Visual CheckThe PINs should not be bent. A module with twisted pins will still work as long as it is the bottom module in the tower. So if you find twisted pins in a module, make sure to position that module in the bottom of the tower.2.8 Identifying a faulty module-The module quantity must be adjusted in the app whenever the number of modules is changed!-Please perform a visual check of the communication pins according to step 2.7 for each module.-Normally a faulty module can be identified with the Be Connect Plus Program or by the LED Code in the Battery Module. In this case, remove the Module with the Event Code from the system, and commission the remaining system (if it still complies with the minimum configuration list) and check if it runsproperly. If the problem remains, please also check the module above the one with the Event Code.-Otherwise, try the LVS Modules one by one, or by adding Modules one by one into the tower and always check if the system can work properly to identify a possibly faulty module.3.1 BMU ReplacementHave you detected a faulty BMU?:After replacing the BMU, please do not forget to re-do the configuration and firmware-update in the app.3.2 PDU Replacement3.3 LVS Module ReplacementAfter replacing a Module, please do not forget to re-do the configuration and firmware-update in the app. (Every module has its own BMS)3. SERVICE TASKSPlease go through the general steps beforehand, see chapter 1.Important: The installation and all other kinds of works or measurements in combination with the BYD Battery-Box are only allowed by professional and qualified electricians. Improper handling can cause danger and damage. This document does not replace the official BYD manuals and documents. No responsibility is accepted for the accuracy of the information..BYD Battery-Box Premium LVS Service Checklist - V1.0 ENService Contact: Europe: EFT-Systems GmbH Australia: Alps Power Pty Ltd。

uptodate数据库使用指南英文回答：Uptodate is a comprehensive medical database that provides healthcare professionals with access to the latest clinical information and evidence-based resources. It is widely used by physicians, nurses, and other healthcare professionals to stay updated on the latest medical research and guidelines. In this guide, I will provide you with a step-by-step overview of how to use Uptodate effectively.1. Registration and Login:To access Uptodate, you need to create an account and login. Start by visiting the Uptodate website and click on the "Register" button. Fill in the required information, including your name, email address, and professional affiliation. Once you have registered, you will receive a confirmation email with instructions on how to activateyour account. Follow the steps to complete the registration process and then login using your credentials.2. Search for a Topic:Once you are logged in, you can start searching for a specific medical topic or question. The search bar is located at the top of the Uptodate homepage. Enter your query and click on the search icon. Uptodate will provide you with a list of relevant articles, guidelines, and other resources related to your search.For example, if you are looking for information on the management of hypertension, you can type "hypertension management" in the search bar. Uptodate will display a list of articles and guidelines on this topic, including the latest research, treatment options, and recommendations.3. Navigating the Article:When you click on an article or guideline, Uptodatewill open the full text for you to read. The article isdivided into sections, making it easy to navigate and find the information you need. You can use the table of contents on the left-hand side to jump to specific sections orscroll through the entire article.Each section of the article provides in-depth information on a specific aspect of the topic. For example, in an article on hypertension management, you may find sections on diagnosis, treatment options, lifestyle modifications, and follow-up care. The information is presented in a clear and concise manner, making it easy to understand and apply in clinical practice.4. Accessing References:Uptodate provides references for all the information presented in the articles. You can access the references by clicking on the "References" tab at the top of the article. This allows you to review the sources and evidence behind the recommendations.For example, if you come across a guideline on themanagement of diabetes, you can click on the "References" tab to see the studies and research papers that support the recommendations. This helps you evaluate the strength of the evidence and make informed decisions in patient care.5. Saving and Printing:Uptodate allows you to save articles and guidelines for future reference. You can bookmark articles by clicking on the "Save" button located at the top of the article. This creates a personalized list of saved articles that you can access anytime from your account.In addition, you can also print articles directly from Uptodate. Simply click on the "Print" button at the top of the article, and Uptodate will generate a printer-friendly version that you can print or save as a PDF.中文回答：Uptodate是一个全面的医学数据库，为医疗专业人员提供最新的临床信息和以证据为基础的资源。

指南：成人和儿童糖摄入量 内容摘要WHO/NMH/NHD/15.2© 世界卫生组织，2015年版权所有。

世界卫生组织出版物可从世卫组织网站（www.who.int）获得，或者自WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland（电话：+41 22 791 3264；传真：+41 22 791 4857；电子邮件：bookorders@who.int）购买。

要获得复制许可或翻译世界卫生组织出版物的许可——无论是为了出售或非商业性分发，应通过世卫组织网站（http://www.who.int/about/licensing/copyright_form/en/index.html）向世界卫生组织出版处提出申请。

本出版物采用的名称和陈述的材料并不代表世界卫生组织对任何国家、领地、城市或地区或其当局的合法地位，或关于边界或分界线的规定有任何意见。

地图上的虚线表示可能尚未完全达成一致的大致边界线。

凡提及某些公司或某些制造商的产品时，并不意味着它们已为世界卫生组织所认可或推荐，或比其它未提及的同类公司或产品更好。

除差错和疏忽外，凡专利产品名称均冠以大写字母，以示区别。

世界卫生组织已采取一切合理的预防措施来核实本出版物中包含的信息。

但是，已出版材料的分发无任何明确或含蓄的保证。

解释和使用材料的责任取决于读者。

世界卫生组织对于因使用这些材料造成的损失不承担责任。

设计和版面：Alberto March由瑞士日内瓦世界卫生组织文件编印服务科印刷内容摘要背景非传染性疾病是主要死亡原因，在2012年全球死亡总数（5600万人）中，3800万人（68%）死于非传染性疾病(1)。

在非传染性疾病导致的死亡中，40%以上（1600万人）过早死亡（即在70岁前死亡）。

在非传染性疾病死亡总数中，近四分之三（2800万人）和大多数过早死亡（82%）发生在低收入和中等收入国家。

医生建议好好休息英语作文The Importance of Rest: A Doctor's Advice。

Rest is an essential part of maintaining good health. As a doctor, I cannot stress enough the importance of getting adequate rest in order to stay healthy and to prevent illness. In today's fast-paced world, it can be easy to overlook the significance of rest, but it iscrucial for both physical and mental well-being.First and foremost, rest is essential for allowing the body to recover and repair itself. When we sleep, our bodies go into a state of rest and repair, during which time our cells and tissues are able to heal and regenerate. Without adequate rest, our bodies become more susceptible to illness and injury, and it becomes more difficult for us to recover from any health issues that we may be facing.Furthermore, rest is important for maintaining a healthy immune system. When we are sleep-deprived, ourimmune system becomes weakened, making it more difficultfor our bodies to fight off infections and illnesses. This is why it is not uncommon for people who are not getting enough rest to become sick more frequently and to take longer to recover from illnesses.In addition to the physical benefits of rest, it is also crucial for maintaining good mental health. When we are sleep-deprived, we are more likely to experience mood swings, irritability, and difficulty concentrating. Chronic sleep deprivation has also been linked to an increased risk of developing mental health issues such as anxiety and depression. By getting adequate rest, we are better able to maintain a positive outlook and to cope with the stresses of daily life.So, how much rest is enough? The amount of rest that each person needs can vary, but as a general guideline, adults should aim for 7-9 hours of sleep each night. Children and teenagers may need even more sleep in order to support their growth and development. It is important to listen to your body and to prioritize rest in your dailyroutine.In conclusion, rest is a crucial component of maintaining good health. As a doctor, I strongly advise my patients to prioritize rest in their daily lives in order to support their overall well-being. By getting adequate rest, we are better able to support our physical and mental health, and to prevent illness. So, the next time you are tempted to sacrifice sleep in order to meet a deadline or to stay up late watching TV, remember the importance ofrest and make it a priority in your life. Your body and mind will thank you for it.。

FDA无菌生产指南-中英文对照版Translated from / 译自：Guidance for IndustrySterile Drug Products Produced by Aseptic Processing —Current Good Manufacturing Practice行业指南无菌加工生产的无菌药品—现行的生产质量管理规范(cGMP）U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)Office of Regulatory Affairs (ORA)September 2004Pharmaceutical CGMPsCopyright SCI Version 1Copyright SCI Version 1Copyright SCI Version 1TABLE OF CONTENTSI. INTRODUCTION (1)简介II. BACKGROUND (2)背景A.Regulatory Framework (3)法规架构B.Technical Framework (3)技术架构III. SCOPE (5)适用范围IV. BUILDINGS AND FACILITIES (6)厂房和建筑A.Critical Area – Class 100 (ISO 5) (8)关键区域– 100级(ISO 5)B. Supporting Clean Areas (11)辅助洁净区域C. Clean Area Separation (11)净化区的隔离D.Air Filtration (13)空气过滤1.Membrane (13)膜过滤2.High-Efficiency Particulate Air (HEPA) (14)高效颗粒空气过滤器(HEPA)E.Design (17)设计V. PERSONNEL TRAINING, QUALIFICATION, & MONITORING (21)人员的培训，资格认定和监控A.Personnel (22)人员boratory Personnel (26)实验室人员C.Monitoring Program (26)监控程序VI. COMPONENTS AND CONTAINER/CLOSURES (28)药品成分和容器/密封A. Components (28)Copyright SCI Version 1药品成分B. Containers/Closures (31)容器/密封1.Preparation (31)准备2. .................................................................................. Inspection of Container Closure System33容器密封系统的检查VII. ENDOTOXIN CONTROL (35)内毒素控制VIII. TIME LIMITATIONS (37)时间限制IX. VALIDATION OF ASEPTIC PROCESSING AND STERILIZATION (38)无菌加工和灭菌的验证A. Process Simulations (38)工艺模拟1.Study Design (39)研究设计2.Frequency and Number of Runs (41)运行频率和次数3.Duration of Runs (42)运行时间4.Size of Runs (43)批量5.Line Speed (44)运行速度6.Environmental Conditions (44)环境质量7.Media (45)培养基8.Incubation and Examination of Media-Filled Units (46)培养基灌装单位的培养和检查9.Interpretation of Test Results (48)试验结果解释B. Filtration Efficacy (50)过滤功效C. Sterilization of Equipment, Containers, and Closures (53)设备、容器和密封的灭菌1.Qualification and Validation (54)确认和验证2.Equipment Controls and Instrument Calibration (56)设备控制和仪器校准X. LABORATORY CONTROLS (59)实验室控制Copyright SCI Version 1A. Environmental Monitoring (61)环境监测1. ...................................................................................................... General Written Program61书面程序2.Establishing Levels and a Trending Program (63)建立监测标准和趋势分析程序3.Disinfection Efficacy (64)消毒功效4.Monitoring Methods (64)监测方法B. Microbiological Media and Identification (66)微生物培养基及微生物的鉴定C. Prefiltration Bioburden (67)过滤前的生物负荷D. Alternate Microbiological Test Methods (68)可替代的微生物测试方法E. Particle Monitoring (68)颗粒监测XI. STERILITY TESTING (69)无菌试验A. Microbiological Laboratory Controls (71)微生物实验室控制B. Sampling and Incubation (71)取样和培养C. Investigation of Sterility Positives (72)无菌试验阳性结果的调查XII. BATCH RECORD REVIEW: PROCESS CONTROL DOCUMENTATION (77)批生产纪录审核：工艺控制文件化APPENDIX 1: ASEPTIC PROCESSING ISOLATORS (79)附录1: 无菌隔离装置APPENDIX 2: BLOW-FILL- SEAL TECHNOLOGY (87)附录2：吹-灌-封技术APPENDIX 3: PROCESSING PRIOR TO FILLING AND SEALING OPERATIONS (91)附录3：灌装和密封前的工艺REFERENCES (94)参考文献RELEVANT GUIDANCE DOCUMENTS (95)相关指南文件GLOSSARY (96)Copyright SCI Version 1术语表Copyright SCI Version 1Guidance for Industry1Sterile Drug Products Produced byAseptic Processing — Current Good Manufacturing PracticeI.INTRODUCTION简介This guidance is intended to help manufacturers meet the requirements in the Agency's current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211) when manufacturing sterile drug and biological products using aseptic processing. This guidance replaces the 1987 Industry Guideline on Sterile Drug Products Produced by Aseptic Processing (Aseptic Processing Guideline). This revision updates and clarifies the 1987 guidance.本指南旨在帮助生产商在应用无菌工艺制造无菌药品和生物制剂时，达到FDA cGMP规章(美国联邦法规的第210及第211节)要求。