歐盟 GMP中英文對(duì)照

1、2020/12/31,Pharmaceutical Services Corporation,How GMPs are regulated in Europe 歐洲藥品生產(chǎn)管理規(guī)范,2,What Is GMP?什么是GMP？,Definition: 定義： The part of Quality Assurance which ensures products are consistently produced and controlled in accordance with the quality standards appropriate for their intended use 質(zhì)

2、量保證的一部分，它確保按產(chǎn)品預(yù)定用途持續(xù)穩(wěn)定地控制生產(chǎn)，保證產(chǎn)品符合質(zhì)量標(biāo)準(zhǔn)要求。,3,What Is GMP?什么是GMP？,The procedures employed to ensure that the drug product or substance is manufactured under a quality management system and meets the claimed requirements for purity, identity, safety and quality 遵循標(biāo)準(zhǔn)操作規(guī)程，以確保藥品的生產(chǎn)在質(zhì)量管理系統(tǒng)的控制中并符合注冊(cè)的純度、鑒別、安

3、全和質(zhì)量 Continuously evolving “feasible and valuable” industry practices designed to ensure the above 持續(xù)地發(fā)展“可行性和有用性”的工業(yè)規(guī)范，以確保達(dá)到以上要求,4,A Brief History of GMPGMP歷史簡(jiǎn)介,1962 The food drug and cosmetic act requires that drugs must be made in accordance with good manufacturing practices 食品、藥品和化妝品法要求藥品必須符合藥品生產(chǎn)

4、管理規(guī)范 1969 WHO publishes Good Practices in the Manufacture and Quality control of drugs 世界衛(wèi)生組織出版了藥品生產(chǎn)和質(zhì)量控制的管理規(guī)范 1971 The guide to good pharmaceutical manufacturing practice (orange guide) published 藥品生產(chǎn)管理規(guī)范指南(orange guide)出版英國(guó)GMP 1976 FDA publishes proposed cGMPS 美國(guó)食品藥物管理局出版了提議的藥品生產(chǎn)管理規(guī)范,5,A Brief His

5、tory of GMPGMP歷史簡(jiǎn)介,1978 Major revision in FDA 21 CFR 210 and 211. 美國(guó)食品藥物管理局的21 CFR 210 和 211重大版本變更 1989 European guide to GMP published 歐盟出版藥品生產(chǎn)管理規(guī)范指南 1991 European commission adopts two directives on principles and guidelines for GMP 歐洲委員會(huì)在藥品生產(chǎn)管理規(guī)范原則和指南上采用兩種條令 1992 European guide to GMP revised. Fu

6、rther annexes added. Some Chapters revised 2008 歐洲藥品生產(chǎn)管理規(guī)范指南更新，添加了新的附錄。2008 年更新了一些章節(jié)。 2003 Commission Directive replaced by 2003/94/EC 歐洲委員會(huì)條令由2003/94/EC取代,6,GMP VariationsGMP的差異,The overall principles of Good Manufacturing Practice are similar whether we follow the WHO Guidelines, the EU Guidelines

7、 or the FDA guidelines 不管是世界衛(wèi)生組織指南、歐洲指南，還是美國(guó)食品藥物管理局指南，藥品生產(chǎn)管理規(guī)范的總體原則是相似的 There are numerous variations in the application of these principles 這些原則在應(yīng)用上有些差異 The enforcement of the guidelines varies between different regulatory authorities 不同法規(guī)組織在指南的實(shí)施上存在差異 The approach taken by individual inspectors va

8、ries 不同檢查人員所采用的方法存在差異 The approach taken by different regulatory authorities varies 不同法規(guī)組織所采用的方法存在差異,7,The GMPs tell us what to do, they do not tell us how to do it. 藥品生產(chǎn)管理規(guī)范告訴我們做什么，而不告訴我們?cè)鯓幼觥?How comes from: 怎樣來(lái)源于： industry standard practice and guidelines 工業(yè)標(biāo)準(zhǔn)規(guī)范和指南,8,Commission Directive 2003/94/E

9、C委員會(huì)條令2003/94/EC,Replaced original directive 91/356/EEC 替代原有條令91/356/EEC Lays down principles and guidelines of GMP for medicinal products for human use 規(guī)定了人用藥品的生產(chǎn)管理規(guī)范的原則和指南 Member states must ensure respect for GMP by means of repeated inspections 通過(guò)反復(fù)檢查，成員國(guó)必須確保遵守藥品生產(chǎn)管理規(guī)范 Interpretation of Principl

10、es and guidelines shall be by reference to the “Guide for good manufacturing practice for medicinal products and for investigational medicinal products” 原則和指南的解釋?xiě)?yīng)參考“藥品和在研藥品的生產(chǎn)管理規(guī)范指南”,9,Commission Directive 2003/94/EC委員會(huì)條令2003/94/EC,For products imported from third country, the importer shall ensure

11、products are manufactured to a standard at least equivalent to GMP as laid down by EU 由第三國(guó)進(jìn)口的藥品，進(jìn)口商要確保藥品的生產(chǎn)達(dá)到至少等同于歐盟規(guī)定的藥品生產(chǎn)管理規(guī)范 Importer shall ensure that products have been manufactured by authorised manufacturers 進(jìn)口商要確保藥品是授權(quán)生產(chǎn)廠家生產(chǎn)的 Must be manufactured in compliance with Marketing Authorisation 藥品

12、的生產(chǎn)必須符合藥品注冊(cè)批準(zhǔn)的要求。,10,Commission Directive 2003/94/EC委員會(huì)條令2003/94/EC,The rest of the Directive briefly summarises the aspects of GMP that must be in place. These are addressed in more detail in the GMP Guide. 條令的其余部分總結(jié)了藥品生產(chǎn)管理規(guī)范必須執(zhí)行的方面。這些在藥品生產(chǎn)管理規(guī)范指南中有更詳細(xì)地說(shuō)明。,11,EU Guidelines to GMP歐洲GMP指南,Published as

13、 Vol 4 of EudraLex by the European Commission 由歐洲委員會(huì)出版，共4卷。 This comprises: 這包括： Introduction 引言 Chapter 1 Quality Management 第一章 質(zhì)量管理 Chapter 2 Personnel 第二章 人員 Chapter 3 Premises and Equipment 第三章 廠房和設(shè)備,12,EU Guidelines to GMP歐洲GMP指南,Chapter 4 Documentation 第四章 文件 Chapter 5 Production 第五章 生產(chǎn) Chapt

14、er 6 Quality Control 第六章 質(zhì)量控制 Chapter 7 Contract Manufacturing and Analysis 第七章 外包生產(chǎn)和樣品分析 Chapter 8 Complaints and Product Recall 第八章 投訴和成品召回 Chapter 9 Self Inspection 第九章 自檢,13,EU Guidelines to GMP歐洲GMP指南,Annex 1 Manufacture of Sterile Medicinal Products 附錄一 無(wú)菌藥品的生產(chǎn) Annex 2 Manufacture of Biologica

15、l Medicinal Products for Human Use 附錄二 人用生物藥品的生產(chǎn) Annex 3 Manufacture of Radiopharmaceuticals 附錄三 放射藥品的生產(chǎn) Annex 4 Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products 附錄四 非免疫動(dòng)物藥品的生產(chǎn) Annex 5 Manufacture of Immunological Veterinary Medicinal Products 附錄五 免

16、疫動(dòng)物藥品的生產(chǎn),14,EU Guidelines to GMP歐洲GMP指南,Annex 6 Manufacture of Medicinal Gases 附錄六 醫(yī)用氣體的生產(chǎn) Annex 7 Manufacture of Herbal Medicinal Products 附錄七 草本藥品的生產(chǎn) Annex 8 Sampling of Starting and Packaging Material 附錄八 原材料和包裝材料的取樣 Annex 9 Manufacture of Liquids, Creams and Ointments 附錄九 液體、乳劑和膏劑的生產(chǎn) Annex 10 Ma

17、nufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation 附錄十 壓力計(jì)量噴霧狀吸入式藥劑的生產(chǎn),15,Annex 11 Computerised Systems 附錄十一 計(jì)算機(jī)系統(tǒng) Annex 12 Use of Ionising Radiation in the Manufacture of Medicinal Products 附錄十二 藥品生產(chǎn)過(guò)程中電離輻射的使用 Annex 13 Manufacture of Investigational Medicinal Products 附錄十三 研究

18、用藥品的生產(chǎn) Annex 14 Manufacture of Medicinal Products derived from Human Blood or Plasma 附錄十四 來(lái)源于人體血液或血漿藥品的生產(chǎn),EU Guidelines to GMP歐洲GMP指南,16,Annex 15 Qualification and Validation 附錄十五 確認(rèn)和驗(yàn)證 Annex 16 Certification by a Qualified Person and Batch Release 附錄十六 藥品放行責(zé)任人簽發(fā)證書(shū)和放行批產(chǎn)品 Annex 17 Parametric Release

19、附錄十七 參數(shù)放行 Annex 18 Not Used (was used for GMP for API) 附錄十八 未使用（以前用于合成制藥的生產(chǎn)管理規(guī)范） Annex 19 Reference and Retention samples 附錄十九 對(duì)照樣品和留樣 Annex 20 Quality Risk Management 附錄二十 質(zhì)量風(fēng)險(xiǎn)管理,EU Guidelines to GMP歐洲GMP指南,17,Who are the Regulators法規(guī)管理者是誰(shuí),European Medicines Agency (EMEA) 歐洲藥品管理局（ EMEA） decentralis

20、ed body of the European Union with headquarters in London. 歐盟的分散機(jī)構(gòu)，其總部在倫敦 The EMEA is responsible for the scientific evaluation of applications for European marketing authorisation for medicinal products (centralised procedure). Under the centralised procedure, companies submit one single marketing

21、authorisation application to the EMEA. EMEA負(fù)責(zé)對(duì)擬在歐洲上市的藥品申請(qǐng)進(jìn)行科學(xué)評(píng)估（集中審評(píng)）。在集中審評(píng)程序下，公司要向EMEA提交單獨(dú)的上市許可申請(qǐng)。,18,All medicinal products for human and animal use derived from biotechnology and other high-technology processes must be approved via the centralised procedure. The same applies to all human medicine

22、s intended for the treatment of HIV/AIDS, cancer, diabetes or neurodegenerative diseases and for all designated orphan medicines intended for the treatment of rare diseases. 所有由生物技術(shù)及其它高科技工藝制備的人用藥品和獸藥產(chǎn)品，都必須通過(guò)集中審評(píng)程序報(bào)批。治療艾滋病、腫瘤、糖尿病、神經(jīng)退化以及罕見(jiàn)病的藥物，也須按照集中審評(píng)程序報(bào)批。,Who are the Regulators法規(guī)管理者是誰(shuí),19,For medicin

23、al products that do not fall under any of the above-mentioned categories companies can submit an application for a centralised marketing authorisation to the EMEA, provided the medicinal product constitutes, a significant therapeutic, scientific or technical innovation or the product is in any other

24、 respect in the interest of patient or animal health. 對(duì)于不屬于上述類(lèi)型的藥品，如果藥效十分明顯，科學(xué)或工藝上有創(chuàng)新，或產(chǎn)品的其它方面對(duì)病人及動(dòng)物的健康十分有益時(shí)，企業(yè)也可向EMEA遞交集中審評(píng)程序的申請(qǐng)。,Who are the Regulators法規(guī)管理者是誰(shuí),20,For a generic, the centralised procedure can be used if the innovator product was centrally authorised 對(duì)于仿制藥，如果創(chuàng)新藥已由集中審評(píng)程序批準(zhǔn)，那么也可以按集中審評(píng)程

25、序申請(qǐng)。 Responsible for coordinating GMP inspections when centralised application process is used. The responsibility for carrying out inspections rests with the Competent Authority under whose responsibility the manufacturer falls. 當(dāng)集中申請(qǐng)程序適用時(shí)，負(fù)責(zé)協(xié)調(diào)GMP檢查。進(jìn)行檢查的責(zé)任取決于生產(chǎn)廠家隸屬于哪家主管當(dāng)局管轄。,Who are the Regulators

26、法規(guī)管理者是誰(shuí),21,EMEA Coordinated GMP InspectionsEMEA 協(xié)調(diào)的GMP檢查,22,From 1995 to 2006, a total of 9465 deficiencies, comprising 193 critical (2%), 989 major (10%) and 8283 other deficiencies (88%) were recorded in the EMEA database during the 435 inspections carried out by EMEA inspectors during the above r

27、eferenced period. 根據(jù)EMEA數(shù)據(jù)庫(kù)的記錄，從1995年至2006年，EMEA檢查人員共進(jìn)行了435次檢查，并共發(fā)現(xiàn)了9465項(xiàng)缺陷。其中包括193項(xiàng)重要缺陷（2%）， 989項(xiàng)主要缺陷（10%）和8283項(xiàng)其他缺陷（88%）。,EMEA Coordinated GMP InspectionsEMEA 協(xié)調(diào)的GMP檢查,23,TOP GMP DeficienciesGMP缺陷排名,24,MHRA A Competent AuthorityMHRA 一個(gè)主管當(dāng)局,The Medicines and Healthcare products Regulatory Agency (M

28、HRA) is the government agency in the UK which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. 藥品和健康產(chǎn)品管理局（MHRA）是英國(guó)的政府機(jī)構(gòu)，其負(fù)責(zé)確保藥品和醫(yī)療器械工作正常且安全性令人滿(mǎn)意。 The GMP Inspectorate division has a team of over 30 inspectors based at the MHRA headquarters in London (Mark

29、et Towers) and at two MHRA outstations (Welwyn Garden City and York ) GMP檢查部門(mén)有30多名檢查員。其總部在倫敦， 另外兩個(gè)分部在Welwyn Garden City 和約克。,25,MHRA： - Responsible for UK inspections when a company is named on a Manufacturing license or has applied for one 負(fù)責(zé)對(duì)英國(guó)區(qū)域內(nèi)已取得生產(chǎn)許可證的公司或提交申請(qǐng)的公司 進(jìn)行檢查 - Responsible for inspecti

30、ng Overseas manufacturing sites when they are named on a specific Marketing Authorisation. Overseas inspections focus on product to be imported 負(fù)責(zé)檢查已獲準(zhǔn)特定市場(chǎng)授權(quán)的國(guó)外生產(chǎn)廠家。國(guó)外檢查著重 于進(jìn)口的產(chǎn)品。,MHRA A Competent AuthorityMHRA 一個(gè)主管當(dāng)局,26,GMP and BusinessGMP和商業(yè),Why should we comply with GMP apart from the fact that t

31、he Regulators tell us we must do so? 除了法規(guī)管理者要求我們必須這樣做之外，我們?yōu)槭裁磻?yīng)該遵循GMP呢？,27,Business Objectives商業(yè)目的,Provide consistent quality product 提供質(zhì)量持續(xù)穩(wěn)定的產(chǎn)品 Maintain consistent, reproducible processes 維持持續(xù)穩(wěn)定的、可再現(xiàn)的生產(chǎn)工藝 Reduce the need of extensive testing of each batch through quality assurance 通過(guò)質(zhì)量保證，減少每批產(chǎn)品擴(kuò)延檢測(cè)

32、的需要 Maintain the ability to reconstruct past production through accurate records 通過(guò)精確的記錄，維持以前生產(chǎn)的再現(xiàn)能力 Develop the ability to predict future process performance based on past results 依據(jù)過(guò)去的結(jié)果，形成預(yù)見(jiàn)未來(lái)工藝性能的能力,28,Business Objectives = GMP Objectives商業(yè)目的 = GMP目的,29,GMP and Good Business PractiseGMP和商業(yè)管理規(guī)范,M

33、eeting our GMP objectives is not only a Regulatory requirement but is makes good business sense because: 滿(mǎn)足GMP目標(biāo)不只是法定管理部門(mén)的要求，也是好的商業(yè)意識(shí)，因?yàn)椋?the amount of product failure should decrease 不合格產(chǎn)品的數(shù)量減少 the process should be more efficient and reproducible 生產(chǎn)工藝更加有效，再現(xiàn)性更強(qiáng) the equipment should be well maintai

34、ned and able to consistently operate within process specifications 設(shè)備得到良好的維護(hù)保養(yǎng)，能夠在工藝標(biāo)準(zhǔn)范圍內(nèi)持續(xù)穩(wěn)定運(yùn)行,30,future performance should be predictable 未來(lái)的性能是可以預(yù)見(jiàn)的 amount of recalls and complaints should decrease 產(chǎn)品召回和投訴的數(shù)量減少 investigations of deviations should be enhanced by the right level of documentation 通過(guò)

35、適合的文件，強(qiáng)化了對(duì)偏差的調(diào)查,GMP and Good Business PractiseGMP和商業(yè)管理規(guī)范,31,Conclusion結(jié)論,Compliance with GMP is a regulatory requirement and makes good business sense 遵循GMP是法定管理部門(mén)的要求，也是好的商業(yè)意識(shí) The general principles of GMP are consistent irrespective of the specific regulator 除去特定的法規(guī)之外，GMP的總體原則是一致的 The application a

36、nd enforcement of specific aspects of GMP are variable GMP的特定方面的應(yīng)用和實(shí)施具有差異性 There are specific differences in some areas between the various guidelines 不同指南的一些條款具有差異性,2020/12/31,Pharmaceutical Services Corporation美國(guó)醫(yī)藥服務(wù)有限公司,Good Documentation Practices (GDP) 文件管理規(guī)范(GDP),Good Documentation Practice 文件

37、管理規(guī)范 The handling of written or pictorial information describing, defining, specifying and/or reporting of certifying activities, requirements, procedures or results in such a way as to ensure data integrity ISPE 描述、定義、規(guī)定或報(bào)告特定的活動(dòng)、要求、規(guī)程或結(jié)果的記錄或圖片的管理，以確保數(shù)據(jù)的完整性 國(guó)際醫(yī)藥工程協(xié)會(huì),Definition 定義,In many cases Docum

38、entation is the only evidence that an activity has taken place in a specific way or even at all. Therefore the documents must be reliable. 大多數(shù)情況下，文件是記錄發(fā)生在某特定場(chǎng)合下某項(xiàng)活動(dòng)的唯一證據(jù)。因此，文件一定要可靠。 List some examples of where the only evidence for activity is the documentation 實(shí)例說(shuō)明,Why do we need GDP 為什么需要文件管理規(guī)范,Do

39、cumentation文件,To perform a GMP task, you must know the requirements, what to do, how to do it and you must record that you have done it. 為執(zhí)行一項(xiàng)GMP任務(wù)，必須知道要求，做什么，怎樣做，以及記錄所做的。 Requirements: Policies, Specifications, URS 要求：政策、規(guī)范、用戶(hù)需求 What to do (Instructions): Plans, Procedures, Protocols 做什么（指令）：計(jì)劃、規(guī)程、

40、方案 How to do it (Training): Training records 怎么做（培訓(xùn)）：培訓(xùn)記錄 What you did: Records 做過(guò)什么：記錄,36,Types of Documents文件種類(lèi),Exercise: List as many Document types as you can for: 練習(xí)：列出以下部門(mén)的文件種類(lèi)： Purchasing 采購(gòu) Production 生產(chǎn) Engineering 工程,37,Types of Documents文件種類(lèi),Document Control 文件控制 Labeling and packaging 標(biāo)簽

41、和包裝 Handling, storage and distribution 裝卸、存放和分發(fā) Quality Control 質(zhì)量控制 Quality Assurance 質(zhì)量保證,Documented evaluation of suppliers, contractors and consultants 記錄在案的對(duì)供應(yīng)商、承包商和咨詢(xún)公司的評(píng)估 Records of acceptable suppliers, contractors and consultants 批準(zhǔn)的供應(yīng)商、承包商和咨詢(xún)公司的記錄 Purchasing requirements for products and s

42、ervices 產(chǎn)品和服務(wù)的采購(gòu)要求,Purchasing采購(gòu),SOPs for Manufacturing, monitoring of process parameters, compliance with specified standards, approval of process and process equipment 標(biāo)準(zhǔn)操作規(guī)程，包括生產(chǎn)、工藝參數(shù)監(jiān)測(cè)、內(nèi)部標(biāo)準(zhǔn)的符合性、工藝及工藝設(shè)備的批準(zhǔn) Environmental control specifications if it could have adverse impact on product 環(huán)境控制標(biāo)準(zhǔn)（如對(duì)產(chǎn)品有

43、不良影響） Policies on Training, Health, Hygiene, Gowning 培訓(xùn)、健康、衛(wèi)生和更衣的規(guī)定 Validation Documents 驗(yàn)證文件,Production生產(chǎn),Design documents for Buildings, Utilities and Equipment 廠房、公用工程和設(shè)備的設(shè)計(jì)文件 Documented Maintenance and Calibration schedule 記錄在案的維修和校正計(jì)劃表 Calibration and control of testing and measuring equipment

44、including procedures, records, limits and tolerances, remedial action, traceable standards. 測(cè)試測(cè)量?jī)x器的校正和控制，其包括標(biāo)準(zhǔn)操作規(guī)程、記錄、接受限度、彌補(bǔ)行動(dòng)、可追蹤的標(biāo)準(zhǔn),Engineering工程,Procedures to control document distribution and approval 文件分發(fā)及批準(zhǔn)的標(biāo)準(zhǔn)操作規(guī)程 Procedures for Approval of changes to documents and communication of changes to

45、 personnel 文件變更批準(zhǔn)及通知人員有關(guān)變更的標(biāo)準(zhǔn)操作規(guī)程,Document Control文件控制,Documented Inspection and test of incoming, in process and finished goods 記錄在案的原料、中控樣品和成品的檢查和測(cè)試 Identification of acceptance status throughout manufacturing, packaging and labeling 貫穿生產(chǎn)、包裝和貼標(biāo)簽整個(gè)過(guò)程中批準(zhǔn)狀態(tài)的識(shí)別,Quality Control質(zhì)量控制,Label storage proced

46、ure so as to prevent mix ups 防止混淆的標(biāo)簽儲(chǔ)存規(guī)程 Documented Label inspection before use 記錄在案的使用前標(biāo)簽的檢查 Documented Labeling operations 記錄在案的貼標(biāo)簽操作 Label legibility and integrity during normal handling after fixing. 正常操作過(guò)程中貼標(biāo)后標(biāo)簽的清晰性和完整性,Labeling and Packaging標(biāo)簽和包裝,Procedures for control of storage areas to prev

47、ent mix ups, deterioration, contamination and to ensure no obsolete, reject or deteriorated product is distributed. 儲(chǔ)存區(qū)域的控制規(guī)程 - 防止物品混淆、變質(zhì)及污染和確保不合格或已變質(zhì)的產(chǎn)品不被發(fā)放。 Procedures for receipt and dispatch from and to storage areas. 儲(chǔ)存區(qū)域的收貨和發(fā)貨的規(guī)程 Distribution records 分發(fā)記錄,Handling, Storage and distribution裝卸、存

48、儲(chǔ)和分發(fā),Procedures for control and disposition of nonconforming products including review and disposition process, evaluation and investigation. 不合格產(chǎn)品的控制及處理規(guī)程，其包括審核、處理工藝過(guò)程、評(píng)估和調(diào)查 Procedures for rework 再加工規(guī)程 Procedures for Investigating non conformities, identifying actions to correct and prevent reoccur

49、rence and verifying actions were effective 對(duì)不符合規(guī)定事件調(diào)查、制定糾正和防范行動(dòng)及確認(rèn)行動(dòng)有效性的規(guī)程,Quality Assurance質(zhì)量保證,Procedures for Implementing changes to correct quality problems 為糾正質(zhì)量問(wèn)題而實(shí)施變更的規(guī)程 Analyzing quality data to detect reoccurring quality problems 質(zhì)量數(shù)據(jù)分析，以檢測(cè)可能再發(fā)生的質(zhì)量問(wèn)題 Quality policy understood, implemented.

50、質(zhì)量方針 - 理解及實(shí)施 Quality Plans and procedures 質(zhì)量計(jì)劃和規(guī)程,Quality Assurance質(zhì)量保證,Documented Quality Audits 記錄在案的質(zhì)量審計(jì) Must maintain a complaint file. Review and evaluate complaints in a timely fashion 必須建立投訴檔案，隨時(shí)審核和評(píng)估投訴。,Quality Assurance質(zhì)量保證,All records must be available for inspection by Regulators for at l

51、east the expected life of the product or in any case not less than 2 years from date of release. 所有記錄必須保留以供法規(guī)人員檢查。記錄保留期限至少為產(chǎn)品的有效期限，或從產(chǎn)品的放行日起算，不少于2年。 Regulators is not entitled to see internal quality audits, supplier audits, evaluation of contractors etc and management review records. 法規(guī)人員無(wú)權(quán)審閱公司內(nèi)部的質(zhì)

52、量審計(jì)、供應(yīng)商審計(jì)、承包商評(píng)估和管理層的審核記錄。,Records記錄,Good Documentation Practice文件質(zhì)量管理規(guī)范,General: 一般原則： Always use ink of suitable darkness to ensure copying will accurately transcribe the numbers 用適合深度的墨水，以確保復(fù)印件清晰 Written entries must be clear, concise and legible using indelible ink (ballpoint pen preferred in mos

53、t cases) 記錄必須清楚、簡(jiǎn)要，字跡清晰。要用持久的墨水筆記錄 （建議使用圓珠筆）。 Records containing photocopied information (e.g. data ) must reference the original source and date, the information was generated. 記錄中若包含復(fù)印件（如數(shù)據(jù)），其復(fù)印件上必須標(biāo)明文件的原始出處及頒布日期。,50,Good Documentation Practice文件質(zhì)量管理規(guī)范,Data must be entered each time. No words (e.g

54、.“As above”) or symbols (e.g., ditto marks or arrows) indicating repeated entries are permitted 必須每次記錄數(shù)據(jù)。對(duì)于重復(fù)的數(shù)據(jù)記錄，不允許使用 “如上所示”、同上符號(hào)或箭頭。 Complete documentation at the time the activity is being executed 當(dāng)工作完成時(shí)，及時(shí)完成記錄 Ensure that data entered is accurate and unambiguous 確保記錄的數(shù)據(jù)準(zhǔn)確、清晰,Good Documentatio

55、n Practice文件質(zhì)量管理規(guī)范,Report actual readings and in addition round numbers to the number of decimal places stated in the requirements 報(bào)告實(shí)際讀數(shù)，并將其修約至規(guī)定的小數(shù)點(diǎn)位數(shù) Ensure that you understand the revision numbering system and always use latest revision 確保理解版本編號(hào)系統(tǒng)并始終使用最新版本,Good Documentation Practice文件質(zhì)量管理規(guī)范,Dat

56、es 日期 Date Format to be used : DD-MMM-YY or DD-MMM-YYYY 日期表示方式： DD-MMM-YY 或 DD-MMM-YYYY Enter the date when you executed the work and signed the document. Back-dating or forward dating is not permitted. 執(zhí)行工作和簽署文件時(shí)記錄日期。不允許簽署以前或未來(lái)的日期。 When a signature and date is required, the date cannot be stamp dat

57、ed, it should be hand written 當(dāng)簽名和日期同時(shí)需要時(shí)，其日期不允許用圖章，而應(yīng)手工記錄。,Good Documentation Practice文件質(zhì)量管理規(guī)范,Corrections 更正 White-out fluid or tape should never be used 不允許使用白色修正液或修正帶 Original entries should not be obliterated or erased 不允許涂掉或擦掉原來(lái)記錄 Corrections should be made with a single line through the error

58、 followed by the initials and date of the person making the correction 更正時(shí)，在錯(cuò)誤處畫(huà)一條線(xiàn)，更正人簽名并記錄日期。,54,Good Documentation Practice文件質(zhì)量管理規(guī)范,the correction shall be signed and dated by the originator, 更正人應(yīng)在更正處簽名并記錄日期 the date shall be the date the correction is made 日期應(yīng)是執(zhí)行更正的日期 explanation for correction

59、shall be provided, if it is not obvious why the correction is made e.g.: “Entry Error” 如更正原因不顯而易見(jiàn)，應(yīng)注明更正原因，如“記錄錯(cuò)誤” always cross out the full number/word, when making correction 更正時(shí)，應(yīng)刪除整個(gè)數(shù)字或字詞,Good Documentation Practice文件質(zhì)量管理規(guī)范,Transcribing 謄寫(xiě) Do not transcribe data with the intention of discarding the original 謄寫(xiě)時(shí)，不要有意去除原始數(shù)據(jù) Do not record data on post it note, scraps of paper, notebooks etc 不要將數(shù)據(jù)記錄在及時(shí)貼、廢紙及筆記本上 G