2012年某公司无菌制剂欧盟GMP检查缺陷-中英对照
欧洲药典EP8.02.6.1无菌检验sterility中英文翻译
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欧洲药典无菌检验-sterility 中英文翻译2.6.1.STERILITY无菌法Thetestisappliedtosubstances,preparationsorarticleswhich,accordingtothePharmacopoeia,arerequiredtobes terile.However,asatisfactoryresultonlyindicatesthatnocontaminatingmicro-organismhasbeenfoundinthesampleexaminedintheconditionsofthetest.本方法适用于按照典要求当无菌的原料、制或其他物。
但是,如果按照本无菌法的果符合要求,说明在条件下未微生物染。
PRECAUTIONSAGAINSTMICROBIALCONTAMINATION微生物染防范Thetestforsterilityiscarriedoutunderasepticconditions.Inordertoachievesuchconditions,thetest environmenthastobeadaptedtothewayinwhichthesterilitytestisperformed.Theprecautionstakentoavo idcontaminationaresuchthattheydonotaffectanymicro-organismswhicharetoberevealedinthetest.Theworkingconditionsinwhichthetestsareperformedaremon itoredregularlybyappropriatesamplingoftheworkingareaandbycarryingoutappropriatecontrols.无菌在无菌的条件下行。
了到达的条件,境当与无菌的操作要求相适。
欧盟GMP中英文对照
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欧盟GMP中英文对照EU GMP (Good Manufacturing Practice) is a set of standards and guidelines that govern the manufacturing of drugs and medicinal products within the European Union. These guidelines are designed to ensure that these products are of high quality and are safe for use by patients.欧盟GMP是一组标准和指南,用于监管欧洲联盟内的药品和医疗产品的生产。
这些准则旨在确保这些产品具有高质量,并且对患者使用安全。
Introduction引言:The European Union has a comprehensive set of guidelines and regulations in place to ensure that drugs and medicinal products manufactured within the EU are of high quality and meet the safety standards required for patient use. These regulations are designed to ensure that the pharmaceutical industry operates at the highest possible level of quality.欧盟已经实施了一套全面的指导方针和法规,以确保在欧盟内制造的药品和医疗产品具有高质量,并符合患者使用所需的安全标准。
这些法规旨在确保制药工业运营在最高水平的质量。
The EU GMP guidelines form the basis for the quality assurance in the manufacture and control of medicinal products within the EU and have been laid down by the European Commission. Theseguidelines are based on the principles of Good Manufacturing Practice and cover all aspects of the production and control of medicinal products, including raw materials, manufacturing premises, equipment, personnel and quality management systems.欧盟GMP指南是欧盟内药品生产和控制质量保证的基础,并由欧洲委员会制定。
欧盟GMP中英文对照之欧阳家百创编
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European Union欧阳家百(2021.03.07)药品生产质量管理规范GUIDE TO GOOD MANUFACTURING PRACTICE FORMEDICINAL PRODUCTS目录第一章质量管理CHAPTER 1: QUALITYMANAGEMENT原则............................................................................................................... .. (5)Principle..................................................................................................... (5)质量保证............................................................................................................... . (5)Quality Assurance................................................................................................... . (5)药品生产质量管理规范(GMP) (7)Good Manufacturing Practice for Medicinal Products (7)质量控制(QC)........................................................................................................... (9)Quality Control....................................................................................................... .. (9)产品质量回顾............................................................................................................... . (10)第二章人员CHAPTER 2:PERSONNEL............................................................................................ ..11 ........................................................................................................................ .. (11)Principle..................................................................................................... .. (11)........................................................................................................................ .. (12)General....................................................................................................... . (12)关键人员............................................................................................................... .. (12)Key Personnel................................................................................................... . (12)培训............................................................................................................... . (12)Training..................................................................................................... .. (15)人员卫生............................................................................................................... (16)Personnel Hygiene...................................................................................................... .. (16)第三章厂房和设备CHAPTER 3: PREMISES AND EQUIPMENT (18)原则............................................................................................................... . (18)Principle..................................................................................................... . (18)厂房............................................................................................................... .. (18)Premises..................................................................................................... . (18)通则............................................................................................................... .. (18)General....................................................................................................... . (18)生产区............................................................................................................... (19)Production Area........................................................................................................... .............19贮存区............................................................................................................... (21)Storage Area........................................................................................................... (21)质量控制区............................................................................................................... .. (22)Quality Control Area........................................................................................................... ..22附助区............................................................................................................... (22)Ancillary Areas.......................................................................................................... (22)设备............................................................................................................... .. (23)Equipment.................................................................................................. . (23)第四章文件CHAPTER 4: DOCUMENTATION................................................................................ .. (24)原则............................................................................................................... .. (24)Principle..................................................................................................... . (24)通则............................................................................................................... .. (25)General....................................................................................................... . (25)文件要求............................................................................................................... .. (27)Documents Required..................................................................................................... (27)Specifications............................................................................................. .. (27)Specifications for starting and packaging materials (27)Specifications for Intermediate and Bulk Products (27)Specifications for Finished Products (28)Manufacturing Formulae and Processing Instructions (28)Packaging Instructions................................................................................................ (30)Batch Processing Records...................................................................................................... .31Batch Packaging Records...................................................................................................... .32Procedures and Records...................................................................................................... ...33 Receipt....................................................................................................... (34)Sampling.................................................................................................... (34)Testing....................................................................................................... (35)Other.......................................................................................................... (35)第五章生产CHAPTER 5: PRODUCTION......................................................................................... .. (36)原则............................................................................................................... .. (36)Principle..................................................................................................... (36)通则........................................ ...................................................................... (36)General....................................................................................................... (36)生产过程中对交叉污染的预防 (39)Prevention of Cross-contamination in Production (39)验证............................................................................................................... .. (40)Validation.................................................................................................. .. (40)原料............................................................................................................... .. (41)Starting Materials.................................................................................................... (41)生产操作:中间产品和待包装产品 (42)Processing Operations: Intermediate and Bulk Products (42)包装材料............................................................................................................... .. (43)PackagingMaterials.................................................................................................... .. (43)包装操作............................................................................................................... .. (44)Packaging Operations.................................................................................................. .. (44)成品............................................................................................................... .. (46)Finished Products..................................................................................................... .. (46)不合格、回收料和退货物料 (46)Rejected, Recovered and Returned Materials (46)第六章质量控制CHAPTER 6: QUALITY CONTROL (48)原则............................................................................................................... .. (48)Principle..................................................................................................... . (48)通则............................................................................................................... .. (48)General....................................................................................................... . (48)质量控制实验室规范 (49)Good Quality Control Laboratory Practice (49)Documentation........................................................................................... .. (49)Sampling.................................................................................................... . (50)Testing....................................................................................................... (52)销售产品的稳定性考察 (54)第七章委托生产与委托检验CHAPTER 7: CONTRACT MANUFACTURE AND ANALYSIS (55)原则............................................................................................................... .. (55)Principle..................................................................................................... . (55)通则............................................................................................................... .. (56)General....................................................................................................... . (56)委托方............................................................................................................... . (56)The Contract Giver.......................................................................................................... (56)受托方............................................................................................................... (57)The Contract Acceptor..................................................................................................... (57)合同............................................................................................................... .. (58)The Contract..................................................................................................... (58)第八章投诉与召回CHAPTER 8: COMPLAINTS AND PRODUCT RECALL (59)原则............................................................................................................... .. (59) (59)投诉............................................................................................................... .. (59)Complaints................................................................................................. .. (59)召回............................................................................................................... . (60)Recalls....................................................................................................... . (60)第九章自查CHAPTER 9: SELF INSPECTION (61)原则............................................................................................................... (61)Principle..................................................................................................... .. (61)附件8 原辅料和包装材料的取样ANNEX8 SAMPLING OF STARTING AND PACKAGING MATERIALS (63)原则............................................................................................................... (63)Principle..................................................................................................... .. (63)人员............................................................................................................... (63)Personnel................................................................................................... (63)原辅料............................................................................................................... .. (63)Starting materials..................................................................................................... . (64)包装材 (65)Packaging material...................................................................................................... . (65)第一章质量管理CHAPTER 1 QUALITY MANAGEMENTPrinciple原则生产许可证持有厂家只能生产医药产品,以确保药品符合其预期的使用目的,符合销售许可证的要求,并不因药品安全性、质量或药效方面的问题而给患者带来风险。
EUGMP附录1无菌产品生产-2020版(中英文对照)
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EUGMP附录1无菌产品生产-2020版(中英文对照)Annex 1 : Manufacture of Sterile ProductsEU GMP 附录1 无菌产品生产-2020版1 Scope范围The manufacture of sterile products covers a wide range of sterile product types (active substance, sterile excipient, primary packaging material and finished dosage form), packed sizes (single unit to multiple units), processes (from highly automated systems to manual processes) and technologies (e.g. biotechnology, classical small molecule manufacturing and closed systems). This Annex provides general guidance that should be used for the manufacture of all sterile products using the principles of Quality Risk Management (QRM), to ensure that microbial, particulate and pyrogen contamination is prevented in the final product.无菌产品的生产涵盖了广泛的无菌药品类型(活性成分,无菌辅料,内包材和制剂),包装量(从单个单位到多个单位),工艺(从高度自动化系统到人工操作)和技术(例如生物技术,常规小分子生产以及密闭系统)。
欧盟GMP(EUGMP)中文版欧洲药品生产和质量管理规范附录1,无菌药品生产
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欧盟GMP(EUGMP)中文版欧洲药品生产和质量管理规范附录1,无菌药品生产盟欧盟 GMP cfu/4 小时 cfu/碟5 指手套cfu/手套A <1 <1 <1 <1B 10 5 5 5C 100 50 25 -D 200 100 50 -注:(a)表中各数值均为平均值。
(b)单个沉降碟的暴露时间可以少于 4 小时。
6.应当对微粒和微生物监控制定适当的警戒和纠偏标准。
操作规程中应详细说明结果超标时应采取的纠偏措施。
隔离技术 7.采用能最大限度降地低生产区人员影响的隔离技术,可大大降低无菌生产中环境对产品微生物污染的风险。
隔离操作台和传递装置的设计可以有多种形式。
隔离操作台及其所处环境的设计,应能保证相应区域空气的质量达到设定标准。
隔离操作台所采用的材料在某种程度上易被穿剌或易产生渗漏。
传输装置可设计成单门的、双门的,甚至可以是同灭菌设备相连的全密封系统。
将物品放入隔离操作台或从中取出属污染风险最为严重的操作过程。
尽管人们认为这类隔离操作器的工作区内不一定要有层流,但是,隔离系统通常是用于进行高污染风险操作的场所。
隔离操作台所处环境的级别取决于它们的设计及其应用。
无菌操作的隔离操作台所处环境的级别应予控制,至少为 D 级。
8.隔离操作台只有经过适当的验证之后方可投入使用。
验证时应当考虑到隔离技术的所有关键性因素,例如,隔离系统内部和外部(所处环境)的空气质量、隔离操作台的消毒、传递操作以及隔离系统的完好性。
9.隔离操作器和隔离用袖管/手套系统应进行常规监测,这包括经常进行必要的检漏试验。
吹气/灌装/密封技术 10.吹气/灌装/密封系统是一套专用机械设备,连续操作,从一个热塑性颗粒吹制成容器至灌装和密封,整个过程由一台全自动机器完成。
用于无菌生产的吹气/灌装/密封设备本身装有 A 级空气风淋装置,在操作人员按A/B 级区要求着装的条件下,该设备可以安装在洁净度至少为C 级的环境中。
欧洲药品GMP检查指南及附件(中英文)
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GUIDE TO GOOD MANUFACTURINGPRACTICE FOR MEDICINAL PRODUCTS药品GMP检查指南.PIC/S July 2004Reproduction prohibited for commercial purposes.Reproduction for internal use is authorised,provided that the source is acknowledged.Editor: PIC/S SecretariatP.O. Box 5695CH-1211 Geneva 11e-mail: daniel.brunner@web site: :// 1 July 2004 PE 009-2TABLE OF CONTENT目录INTRODUCTION介绍 (1)CHAPTER 1 QUALITY MANAGEMENT 质量管理 (4)PRINCIPLE 原则 (4)QUALITY ASSURANCE 质量保证 (4)GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS (GMP) 药品GMP (6)QUALITY CONTROL 质量控制 (7)CHAPTER 2 PERSONNEL 人员 (10)PRINCIPLE 原则 (10)GENERAL 通则 (10)KEY PERSONNEL 关键人员 (10)TRAINING 培训 (13)PERSONAL HYGIENE 个人卫生 (14)CHAPTER 3 PREMISES AND EQUIPMENT 厂房和设备 (16)PRINCIPLE 原则 (16)PREMISES General总则 (16)Production Area 生产区域 (17)Storage Areas 储存区域 (19)Quality Control Areas 质量控制区域 (20)Ancillary Areas 辅助区域 (20)EQUIPMENT 设备 (21)CHAPTER 4 DOCUMENTATION 文件 (23)PRINCIPLE 原则 (23)GENERAL 总则 (23)DOCUMENTS REQUIRED 必需的文件 (25)MANUFACTURING FORMULA AND PROCESSING INSTRUCTIONS 生产方法和加工指示 (27)PACKAGING INSTRUCTIONS 包装指示 (28)BA TCH PROCESSING RECORDS 批加工记录 (29)BA TCH PACKAGING RECORDS 批包装记录 (30)PROCEDURES AND RECORDS 程序和记录 (32)CHAPTER 5 PRODUCTION 生产 (36)PRINCIPLE 原则 (36)GENERAL 通则 (36)PREVENTION OF CROSS-CONTAMINATION IN PRODUCTION 生产过程中防止交叉污染 (38)V ALIDATION 验证 (39)STARTING MA TERIALS 起始物料 (40)PROCESSING OPERA TIONS - INTERMEDIATE AND BULK PRODUCTS 加工操作:中间体和散装产品 (42)PACKAGING MATERIALS 包装材料 (42)PACKAGING OPERATIONS 包装操作 (43)FINISHED PRODUCTS 最终成品 (45)REJECTED, RECOVERED AND RETURNED MATERIALS 拒绝的,回收的和退回的物料46CHAPTER 6 QUALITY CONTROL 质量控制 (48)PRINCIPLE 原则 (48)GENERAL 通则 (48)GOOD QUALITY CONTROL LABORATORY PRACTICE 优良质量控制实验室实践 (49)DOCUMENTATION 文件 (49)SAMPLING 取样 (50)TESTING 检测 (52)CHAPTER 7 CONTRACT MANUFACTURE AND ANAL YSIS 合同加工和分析 (55)PRINCIPLE 原则 (55)GENERAL 通则 (55)THE CONTRACT GIVER 合同提供人 (55)THE CONTRACT ACCEPTOR 合同接受人 (56)THE CONTRACT 合同 (57)CHAPTER 8 COMPLAINTS AND PRODUCT RECALL 抱怨和产品召回 (59)PRINCIPLE 原则 (59)COMPLAINTS 抱怨 (59)RECALLS 召回 (60)CHAPTER 9 SELF INSPECTION 自检 (61)PRINCIPLE 原则 (61)ANNEX 1 MANUFACTURE OF STERILE MEDICINAL PRODUCTS无菌药品的生产 (63)PRINCIPLE (63)GENERAL (63)BLOW/FILL/SEAL TECHNOLOGY (67)TERMINALL Y STERILISED PRODUCTS (67)ASEPTIC PREPARA TION (68)PERSONNEL (68)PREMISES (70)EQUIPMENT (71)SANITATION (71)PROCESSING (71)STERILISATION (73)STERILISATION BY HEA T (74)MOIST HEAT (75)DRY HEAT (75)STERILISATION BY RADIATION (75)STERILISATION WITH ETHYLENE OXIDE (76)FILTRATION OF MEDICINAL PRODUCTS WHICH CANNOT BE STERILISED IN THEIR FINAL CONTAINER (77)FINISHING OF STERILE PRODUCTS (77)QUALITY CONTROL (78)ANNEX 2 MANUFACTURE OF BIOLOGICAL MEDICINAL PRODUCTS FOR HUMAN USE人用生物药品的生产 (79)SCOPE (79)PRINCIPLE (79)PERSONNEL (80)PREMISES AND EQUIPMENT (81)ANIMAL QUARTERS AND CARE (82)DOCUMENTATION (82)PRODUCTION (83)QUALITY CONTROL (84)ANNEX 3 MANUFACTURE OF RADIOPHARMACEUTICALS 放射性药品的生产 (85)PRINCIPLE (85)PERSONNEL (85)PREMISES AND EQUIPMENT (85)PRODUCTION (86)QUALITY CONTROL (86)DISTRIBUTION AND RECALLS (86)ANNEX 4 MANUFACTURE OF VETERINARY MEDICINAL PRODUCTS OTHER THAN IMMUNOLOGICALS MANUFACTURE OF PREMIXES FOR MEDICATED FEEDING STUFFS 除为预混合加药饲料原料生产的免疫产品以外的,兽药产品的生产 (87)THE MANUFACTURE OF ECTOPARASITICIDES (88)THE MANUFACTURE OF VETERINARY MEDICINAL PRODUCTS CONTAINING PENICILLINS (88)RETENTION OF SAMPLES (point 1.4. viii and point 6.14.) (88)STERILE VETERINARY MEDICINAL PRODUCTS (88)ANNEX 5 MANUFACTURE OF IMMUNOLOGICAL VETERINARY MEDICAL PRODUCTS免疫兽药产品的生产 (89)PRINCIPLE (89)PERSONNEL (89)PREMISES (90)EQUIPMENT (93)ANIMALS AND ANIMAL HOUSES (94)DISINFECTION - WASTE DISPOSAL (94)PRODUCTION (95)STARTING MA TERIALS (95)QUALITY CONTROL (98)ANNEX 6 MANUFACTURE OF MEDICINAL GASES药用气体的生产 (99)1. PRINCIPLE (99)2. PERSONNEL (99)3. PREMISES AND EQUIPMENT (99)4. DOCUMENTA TION (100)5. PRODUCTION (101)6. QUALITY CONTROL (104)7. STORAGE AND RELEASE (105)ANNEX 7 MANUFACTURE OF HERBAL MEDICINAL PRODUCTS草药产品的生产 (108)PRINCIPLE (108)PREMISES (108)DOCUMENTATION (108)SAMPLING (109)QUALITY CONTROL (110)ANNEX 8 SAMPLING OF STARTING AND PACKAGING MA TERIALS起始物料和包装材料的取样 (111)PRINCIPLE (111)PERSONNEL (111)STARTING MA TERIALS (111)PACKAGING MATERIAL (112)ANNEX 9 MANUFACTURE OF LIQUIDS, CREAMS AND OINTMENTS流体,霜体和膏体药品的生产 (113)PRINCIPLE (113)PRODUCTION (113)ANNEX 10 MANUFACTURE OF PRESSURISED METERED DOSE AEROSOL PREPARATIONS FOR INHALATION吸入式剂量仪的气雾剂的生产 (115)PRINCIPLE (115)GENERAL (115)PREMISES AND EQUIPMENT (115)PRODUCTION AND QUALITY CONTROL (116)ANNEX 11 COMPUTERISED SYSTEMS 计算机化系统 (117)PRINCIPLE (117)PERSONNEL (117)V ALIDATION (117)ANNEX 12 USE OF IONISING RADIATION IN THE MANUFACTURE OF MEDICINAL PRODUCTS使用离子放射生产药品 (120)INTRODUCTION (120)RESPONSIBILITIES (120)DOSIMETRY (121)V ALIDATION OF THE PROCESS (121)COMMISSIONING OF THE PLANT (122)PREMISES (124)PROCESSING (124)DOCUMENTATION (126)MICROBIOLOGICAL MONITORING (126)ANNEX 13 MANUFACTURE OF INVESTIGA TIONAL MEDICINAL PRODUCTS观察期药品的生产 (127)PRINCIPLE (127)GLOSSARY (128)QUALITY MANAGEMENT (130)PERSONNEL (130)PREMISES AND EQUIPMENT (130)DOCUMENT A TION (131)PRODUCTION (132)QUALITY CONTROL (136)RELEASE OF BATCHES (137)SHIPPING (139)COMPLAINTS (139)RECALLS AND RETURNS (139)DESTRUCTION (140)ANNEX 14 MANUFACTURE OF PRODUCTS DERIVED FROM HUMAN BLOOD OR HUMAN PLASMA生产自人类血液或人体组织分离的产品 (143)PRINCIPLE (143)GLOSSARY (144)QUALITY MANAGEMENT (144)PREMISES AND EQUIPMENT (145)BLOOD AND PLASMA COLLECTION (145)TRACEABILITY AND POST COLLECTION MEASURES (146)PRODUCTION AND QUALITY CONTROL (147)RETENTION OF SAMPLES (148)DISPOSAL OF REJECTED BLOOD, PLASMA OR INTERMEDIATES (148)ANNEX 15 QUALIFICATION AND V ALIDATION 确认和验证 (149)PRINCIPLE (149)PLANNING FOR V ALIDATION (149)DOCUMENTATION (150)QUALIFICATION (150)PROCESS V ALIDATION (151)CLEANING VALIDATION (153)CHANGE CONTROL (154)REV ALIDATION (154)GLOSSARY (154)[ANNEX 16] [QUALIFIED PERSON AND BA TCH RELEASE]*经授权的人员和批放行 (157)ANNEX 17 PARAMETRIC RELEASE参数放行 (158)1. PRINCIPLE (158)2. PARAMETRIC RELEASE (158)3. PARAMETRIC RELEASE FOR STERILE PRODUCTS (158)4. GLOSSARY (160)[ANNEX 18] [GMP GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS] 17原料药GMP 指南 (161)GLOSSARY术语表 (162)GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS药品GMP指南INTRODUCTION介绍为进一步消除药品贸易壁垒,促进许可证的一致性,以及确保整个欧洲在研发,生产和控制药品中保持高标准的质量保证,根据药品检查协会(PIC)同意,药品检查使用一致的GMP原则,和药品检查合作计划表中的欧洲药品GMP及其附录。
EU-GMP欧盟GMP中文版
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欧盟药品管理规则第 4 卷药品生产质量管理规范1998 版欧洲共同体前言欧洲共同体制药工业在药品的开发,生产和控制过程中保持高标准的质量保证。
上市许可系统保证由有能力的权威机构对药品的安全,质量和有效性是否达到相应的规定进行评估。
生产许可系统保证在欧洲市场上获准销售的药品是由授权的生产商生产,其日常活动由权威机构定期检查。
无论是在欧共体之内销售,还是在欧共体之外销售,所有欧共体的药品生产企业都必须通过生产许可。
有两个药品生产和质量管理指导原则,药品生产和质量管理规范(GMP)和指南来源于两个指导原则, 一个是人用药物指导原则(指导原则91/356/EEC)一个是兽用药物指导原则(指导原则91/412/EEC),这两个指导原则1991年被欧共体采纳。
根据这些原则,制定了详细的药品生产和质量管理规范,用于对申请生产许可的企业进行评估和对药品生产企业进行检查的基础。
GMP的原则和详细的指南适用于需要按照第16条75/319/ EEC和修改的第24条81/851/EEC要求认证的所有的操作。
也与所有其它大规模药品生产过程,诸如医院负责的临床试验用药的制备有关。
所有的成员国和工业企业本身都同意GMP适用于人用药物的生产,也适用于兽用药物的生产。
在两个附录中对兽用药品和兽用免疫药品的GMP指南做了详细的调整。
指南用章来表述,每章用标题来概括章节的原则内容。
第一章质量管理列出了药品生产的质量保证的基本概念。
后续各章的原则列出了质量保证的目标和提供了足够的让生产商在执行这一原则时所必须考虑的基本要素。
这一指南除了在9个章节中表述了GMP的基本要素外, 还包括一系列附录提供了与之有关的活动的特定范围的细节。
有时几个附录同时使用,如关于无菌制剂,辐射性药物,生化药物的附录。
在附录后还列出了这一指南所使用的术语表.指南的第一版在1989 年出版, 包括一个无菌药品生产的附录。
第二版在1992 年1月出版; 欧共体指到原则包括给人用药品和兽用药品的GMP提供原则和指南的欧共体于1991 年6月13 日颁布的91/356指导原则和1991 年7月23 日颁布的91/412指导原则。
欧盟GMP(中英文对照)
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欧盟GMP中英文对照( +30 )药品生产质量管理规范GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS第一章质量管理CHAPTER 1: QUALITY MANAGEMENT原则 (5)Principle (5)质量保证. (5)Quality Assurance (5)药品生产质量管理规范(GMP) (7)Good Manufacturing Practice for Medicinal Products (7)质量控制(QC) (9)Quality Control (9)产品质量回顾 (10)第二章人员CHAPTER 2: PERSONNEL........................ .. (11)原则 (11)Principle (11)通则 (12)General...................................................... . (12)关键人员 (12)Key Personnel (12)培训 (12)Training..................... . (15)人员卫生 (16)Personnel Hygiene (16)第三章厂房和设备CHAPTER 3: PREMISES AND EQUIPMENT (18)原则 (18)Principle (18)厂房 (18)Premises (18)通则 (18)General (18)生产区 (19)Production Area (19)贮存区 (21)Storage Area (21)质量控制区 (22)Quality Control Area (22)附助区 (22)Ancillary Areas (22)设备 (23)Equipment (23)第四章文件CHAPTER 4: DOCUMENTATION (24)原则 (24)Principle (24)通则 (25)General (25)文件要求 (27)Documents Required (27)Specifications (27)Specifications for starting and packaging materials (27)Specifications for Intermediate and Bulk Products (27)Specifications for Finished Products (28)Manufacturing Formulae and Processing Instructions (28)Packaging Instructions (30)Batch Processing Records (31)Batch Packaging Records. (32)Procedures and Records (33)Receipt (34)Sampling (34)Testing (35)Other (35)第五章生产CHAPTER 5: PRODUCTION (36)原则 (36)Principle (36)通则 (36)General (36)生产过程中对交叉污染的预防 (39)Prevention of Cross-contamination in Production (39)验证 (40)Validation (40)原料 (41)Starting Materials (41)生产操作:中间产品和待包装产品 (42)Processing Operations: Intermediate and Bulk Products (42)包装材料 (43)Packaging Materials (43)包装操作 (44)Packaging Operations (44)成品 (46)Finished Products (46)不合格、回收料和退货物料 (46)Rejected, Recovered and Returned Materials (46)第六章质量控制CHAPTER 6: QUALITY CONTROL (48)原则 (48)Principle (48)通则 (48)General... . (48)质量控制实验室规范 (49)Good Quality Control Laboratory Practice (49)Documentation (49)Sampling (50)Testing... (52)销售产品的稳定性考察 (54)第七章委托生产与委托检验CHAPTER 7: CONTRACT MANUFACTURE AND ANALYSIS (55)原则 (55)Principle (55)通则 (56)General (56)委托方 (56)The Contract Giver (56)受托方 (57)The Contract Acceptor (57)合同 (58)The Contract (58)第八章投诉与召回CHAPTER 8: COMPLAINTS AND PRODUCT RECALL (59)原则 (59)Principle (59)投诉 (59)Complaints (59)召回 (60)Recalls (60)第九章自查CHAPTER 9: SELF INSPECTION (61)原则 (61)Principle (61)附件8 原辅料和包装材料的取样ANNEX8 SAMPLING OF STARTING AND PACKAGING MATERIALS (63)原则 (63)Principle (63)人员 (63)Personnel (63)原辅料 (63)Startingmaterials (64)包装材料 (65)Packaging material (65)欧盟GMP中英文对照02第一章质量管理CHAPTER 1 QUALITY MANAGEMENTPrinciple原则生产许可证持有厂家只能生产医药产品,以确保药品符合其预期的使用目的,符合销售许可证的要求,并不因药品安全性、质量或药效方面的问题而给患者带来风险。
EUGMP中英文对照1
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EU GMP ANNEX 1 MANUFACTURE OF STERILE MEDICINAL PRODUCTS(中英文对照)在A 级区,每个采样点取样量应不小于 1 m 3。
A 级尘埃粒子分类是根据 ISO 4.8粒 子》5.0卩的数量定义的。
B 级(静态) 尘埃粒子分类根据ISO 5要考虑两种大 小的粒子。
C 级(静态&动态)粒子分类 分别根据ISO7和ISO8。
D 级(静态)粒 子分类是ISO 8。
分类是根据EN/ISO 14644-1方法论,既明确了最少的取样点 数,也规定了取样量和相适应的级别的最 大允许颗粒大小和采集数据评价方法。
洁净分级应使用一个带有短取样管的便 携式颗粒计数器,因为使用长距离的取样 管会采集到远距离猛然落下 > 5.0卩的 粒子的几率相对较高。
单向气流系统应使 用等动力采样头。
操作或在无菌分装的情况下,需要这方面 的规定。
EN ISO 14644-2提供了相关测 试资料,以证明连续的符合洁净区的分 类。
洁净室及洁净空气A 级区,粒子监测应覆盖全部的关键操 作,包括设备装配,除非有正当理由证明 污染物这个进程将损害粒子计数器或具 有危险性,例如:活生物体和辐射危害。
在这类情况下,日常设定操作的监测应该 在暴露之前评估风险,模拟操作期间也应 该监测。
应该监测 A 级区域以一定的频 率和适当采样量,所有干预、瞬变事件和 任何系统恶化都能被捕获,并且如果超出 报警限能报警。
分装操作过程中,> 5.0 微粒可能不总是符合较低的标准要求的,5. For classificatio n purposes in Grade A zon es, a3minimum sample volume of 1m should be take n per sample locati on. For Grade A the airbor ne particleclassification is ISO 4.8 dictated by the limit for particles > 5.0 Grmd F(Br (at rest) the airborne particle classification is ISO 5 for both con sidered particle sizes. . For Grade C (at rest & in operation) the airborne particle classification is ISO 7 and ISO 8 respectively. For Grade D (at rest) the airborne particle classification is ISO 8. For classification purposes EN/ISO 14644-1 methodology defi nes both the minimum nu mber of sample locati ons and the sample size based on the class limit of the largest con sidered particle size and the method of evaluati on of the data collected. 6. Portable particle coun ters with a short len gth of sample tub ing should be used fo classificati on purposes because of the relatively higher rate of precipitation of particles > 5.0 卩 min remote sampling systems with long len gths of tub in g. Iso kin etic sample heads shall be used in uni direct ional airflow systems. 7.“In operati on ” classificati on may be dem on str动态d'是在正常生产条件下定义的,模拟during normal operations, simulated operations or duringmedia fills as worst-case simulation is required for this. EN ISO 14644-2 provides in formati on on testi ng to dem on strate con ti nued complia nee with the assig ned clea nli ness classificati ons.Clean room and clean air device monitoring8. Clea n rooms and clea n air devices should be routinely monitored in operation and the monitoring locati ons based on a formal risk an alysis study and the results obtained during the classification of rooms an d/or clea n air devices. 9. For Grade A zones, particle monitoring should be undertaken for the full duration of critical processing, including equipment assembly, except where justified by contaminants in the process that would damage the particle coun ter or prese nt a hazard, e.g. live organisms and radiological hazards. In such cases monitoring during routine equipment set up operati ons should be un dertake n prior to exposure to the risk. Monitoring during simulated operations should also be performed. The Grade A zone should be mon itored at such a freque ncy and with suitableEUGMP只要证明微粒或小滴是从产品产生的就 可以了。
新版GMP不同剂型企业存在缺陷项举例
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新版GMP不同剂型企业存在缺陷项举例第一篇:新版GMP不同剂型企业存在缺陷项举例新版GMP不同剂型企业存在缺陷项举例(不注明企业名字)冻干粉针剂生产线现场检查主要缺陷:在动态情况下如何维持A级区域内良好气流组织形式,要求提供更加充分的证据;半加塞后产品由操作人员从灌装机出瓶区取出人工转运至层流车内,岗位操作SOP规定不够细致;胶塞转运过程未进行动态的气流流行确认。
(对应无菌附录第32、33条)一般缺陷:原辅料秤量室的设置、记录填写规范性、警戒限行动限超标后的处理、清洁验证最难清洁部位的确认、设备自动检测工位的定期功能确认、委托检验合同的订立等;生物制剂企业现场检查主要缺陷:企业对流感疫苗与甲注射液共用清洗间与器具湿热灭菌柜的风险评估报告中,缺少对预防用生物制品与治疗用化学药品、不同给药途径产品相互影响进行有效评估;生产车间非洁净控制区的储存间中,同时存放甲注射液与流感疫苗的生产用器具,未分区存放且无标识;(对应GMP的第15条)外购的免洗安瓿瓶采用纸盒加气泡缓冲垫的包装形式,供应商审计中未对包装形式进行确认;直接通过D级脱去纸盒包装后传入干热灭菌柜;生产过程中也未对免洗安瓿瓶对该生产环境的潜在影响进行评估;(对应GMP的第198条)批号为ESE20100606的甲注射液的含量测定项目缺少具体操作过程、实验条件及仪器参数相关信息,无法进行有效审核;(对应GMP 的第223条)中药制剂(不含注射剂)现场检查主要缺陷:1.红外、高效液相等仪器原始检验图谱保存在电脑中,未在批检验记录中保存;(对应GMP的第223条)一般缺陷:液体车间个别操作间(如:卫生工具清洗间、存放间)地面局部破损,不平整,未及时维护;(对应GMP的第49条)前处理(净料)车间净料暂存库存放的薄荷、川芎等净药材未按规定的条件储存;(对应GMP的中药制剂附录第21条)验证主计划(文件编号:AD-G59-ZL0001)未对空调净化系统、水系统年度质量回顾等相关内容提出要求;(对应GMP的第145条)液体车间有十二台洗、灌、封联运生产线,每批产品生产时使用六台洗、灌、封联动生产线,安神补脑液批生产记录设计中只能记录一台设备的工艺参数;(对应GMP的第175条)《液体车间FSZKW30,FSZKW40型组合式空调机组清洁规程》(文件编号:AD-G64-YT0023)规定清洗、更换初中效过滤器依据不合理,未规定记录压差初始阻力;(对应GMP的第183条)小容量注射剂现场检查主要缺陷:公司未启动A级区悬浮粒子在线监测系统的报警功能,对报警装置2-4小时巡检的SOP缺少验证数据支持。
药品GMP认证检查缺陷举例(严重、主要、一般缺陷2012)
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药品GMP认证检查缺陷举例附件1 严重缺陷举例本附件列举了部分严重缺陷情况,但并未包含该类缺陷的全部,可根据需要增加其它的缺陷。
人员-高风险产品生产企业的质量管理或生产管理负责人无药学或相关专业本科学历(或中级专业技术职称或执业药师资格),且对其负责的工作缺乏足够的实践经验。
厂房-无空气过滤系统以消除生产或包装时容易产生的空气污染。
-有大范围交叉污染,表明通风系统普遍存在故障。
-生产区或检验区未与其它用于高风险产品的生产区有效分隔。
-厂区卫生状况差,到处有生产残留物积聚/有清洁不充分导致的异物。
-虫害严重。
设备-用于高风险产品的复杂生产操作用设备未经确认符合要求,且有证据表明存在故障。
生产管理-无书面的生产处方。
-生产处方或生产批记录显示有明显的偏差或重大的计算错误。
-伪造或篡改生产和包装指令。
质量管理-质量管理部门不是明确的独立机构,缺乏真正的决定权,有证据表明质量管理部门的决定常被生产部门或管理层否决。
原辅料检验-伪造或篡改分析结果。
成品检验-批准放行销售前,未按照所适用的质量标准完成对成品的检验。
-伪造或篡改检验结果/伪造检验报告。
记录-伪造或篡改记录。
稳定性-无确定产品效期的数据。
-伪造或篡改稳定性考察数据/伪造检验报告。
无菌产品-关键灭菌程序未经验证。
-注射用水(WFI)系统未经验证,有证据表明存在微生物/内毒素超标的情况。
-未做培养基灌装验证以证明无菌灌装操作的有效性。
-无菌灌装产品在灌装期间无环境控制/未监控微生物。
-培养基灌装验证失败后仍继续进行无菌灌装生产。
-未对首次无菌检查不合格进行彻底调查,就根据复试结果批准放行产品。
附件2 主要缺陷举例本附件列举了部分主要缺陷情况,但并未包含该类缺陷的全部,可根据需要增加其它的缺陷。
人员-生产企业的质量管理或生产管理负责人无药学或相关专业本科学历(或中级专业技术职称或执业药师资格),且对其负责的工作缺乏足够的实践经验。
-委托无足够资质的的人员履行质量管理部门或生产部门的职责。
欧盟GMP中英文对照
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欧盟GMP中英文对照————————————————————————————————作者: ————————————————————————————————日期:European Union药品生产质量管理规范GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINALPRODUCTS目录第一章质量管理CHAPTER 1: QUALITY MANAGEMENT原则............................................................ ..................................................... ....................................5Principle.................................................................................................................................................. (5)质量保证........................................................................................................ ................................ (5)Quality Assuranc e.....................................................................................................................................5药品生产质量管理规范(GMP).................................................................................................7 GoodManufacturing Practicefor Medicinal Products........................................................................... (7)质量控制(QC) ................................................................................................................................ (9)Quality Control.................................................................................................................................... (9)产品质量回顾....................... ...........................................................................................................10第二章人员CHAPTER 2:PERSONNEL...................................................................................... ........11原则................................................................................................................................... (11)Principle..................................................................................................................................11通则.......................................................................................... ............................. (12)General...................................................................................................................... .............12关键人员................................................................................................................... ............................12Key Personnel................................................................................................................ ...........................12培训................................................................................................... ....................................................... 12Training..................................................................................................................................15人员卫生................................................................................................................................................16Personnel Hygien e...................................................................................................................................16第三章厂房和设备CHAPTER3: PREMISESAND EQUIPMENT................................................................ ..............18原则..................................................................................................................................... (18)Principle....................................................................................................................................18厂房.........................................................................................................................................18Premises....................................................................................................................................18通则.......................................................................................................................... (18)Genera l......................................................................................... .............................................18生产区................................................................................................................................. (19)Production Area............................................................................................................... (1)9贮存区........................................................................................ ............................................21Storage Area....................................................................................................................... (21)质量控制区.......................................................................................................................22Quality Control Area.......................................................................................................... (22)附助区............................................................................ .....................................................22Ancillary Area s......................................................................................................................22设备......................................................................................................................................23Equipment.......................................................................... .............................................. (23)第四章文件CHAPTER 4: DOCUMENTATIO N.....................................................................................24原则............................................................................ ..........................................................24Principle.................................................................................................................................24通则......................................................................................................................................25 General...................................................................................................................................25文件要求.............................................................................................................................27DocumentsRequired..............................................................................................................27Specifications................................................................................... .......................................27Specifications for startingandpackaging materials...............................................................27Specifications for Intermediateand Bulk Products............................................................ (2)Specifications for Finished Products......................................................................................28 ManufacturingFormulae and Processing Instructions...........................................................28PackagingInstruction s............................................................................................................30Batch Processing Records.......................................................................................................31BatchPackaging Records................................................................................................... (3)Procedures and Records........................................................................................ .................33Receipt.....................................................................................................................................34Sampling..................................................................................................................................34Testin g.....................................................................................................................................35Other........................................................................................................................................35第五章生产CHAPTER5:PRODUCTIO N......................................... .....................................................36原则........................................ ..............................................................................................36Principle..................................................................................... ..................................... (36)通则................................................................................. .................................................. (36)Genera l.....................................................................................................................................36生产过程中对交叉污染的预防....................................................................................39 Prevention ofCross-contamination in Production..................................................................39验证........................................ ..............................................................................................40Validation................................. ........................................... ...................................................40原料........................................ ..............................................................................................41Starting Materials..................... ........................................................ ......................................41生产操作:中间产品和待包装产品................................................................... (4)Processing Operations:Intermediate andBulk Products.................................................. (42)包装材料.............................................................................................................................43Packaging Materials.......................... .....................................................................................43包装操作........................................ .....................................................................................44Packaging Operations.......................................................................................................... (44)成品........................................ ...................................................................... (46)Finished Products..................... ..............................................................................................46不合格、回收料和退货物料........................................................................................46Rejected, Recovered and Returned Materials........................................................................46第六章质量控制CHAPTER6: QUALITY CONTROL.......................................................................... (48)原则......................................................................................................................................48Principle.............................................................................................................................. (48)通则........................................ ......................................... .....................................................48General... ............................................................................................ ................................ (4)质量控制实验室规范......................................................................................................49Good Quality Control Laboratory Practice.............................................................................49 Documentation........................................................................................................................49Sampling................................................................................................................................50Testing... ................................................................................................ ................................52销售产品的稳定性考察.................................................................................................54第七章委托生产与委托检验CHAPTER 7:CONTRACTMANUFACTURE ANDANALYSIS................................... (55)原则........................................ ..............................................................................................55Principle................................... ................................................. .................................... (55)通则........................................ ..............................................................................................56General..................................... ...................................................... ........................................56委托方............................................................................. .....................................................56The Contract Give r................................................................................................................56受托方.................................... .............................................................................................57The Contract Acceptor.............. .......................................................................................... (57)合同......................................................................................................................................58The Contract............................. .............................................................................................58第八章投诉与召回CHAPTER 8:COMPLAINTS AND PRODUCT RECALL..................................................59原则........................................ ..............................................................................................59Principle.................................... ..............................................................................................59投诉......................................................................................................................................59Complaints................................ ................................................. ......................................... (5)召回........................................................................................................................................60Recall s.......................................................................................................................... (60)第九章自查CHAPTER 9:SELF INSPECTION..................................................................................... (61)原则.................................................................................. .....................................................61Principl e...................................................................................................................... (61)附件8ﻩ原辅料和包装材料的取样ANNEX8SAMPLING OF STARTING ANDPACKAGING MATERIALS................. (63)原则.......................................................................................................................................63Principle..................................................................................................................................63人员.......................................................................................................................................63Personne l............................................................................. ....................................................63原辅料............................................................................... ................................................. (63)Starting materials.....................................................................................................................64包装材料...............................................................................................................................65Packaging material...................................................................................................................65第一章质量管理CHAPTER 1QUALITYMANAGEMENTPrinciple原则生产许可证持有厂家只能生产医药产品,以确保药品符合其预期的使用目的,符合销售许可证的要求,并不因药品安全性、质量或药效方面的问题而给患者带来风险。
欧盟GMP附录1(征求意见稿)无菌药品-中英文对照
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Annex 1 Manufacture of Sterile Medicinal Products 附录1 无菌药品的生产Document map文件结构图Section Number 章节号General overview 总览1. Scope 1.范围Additional areas (other than sterile medicinal products) where the general principles of the annex can be applied.可适用附录总则的额外区域(无菌药品除外)2. Principle 2.原则General principles as applied to the manufacture of medicinal products. 适用于药品生产的总体原则。
3. Pharmaceutical Quality System (PQS) 3.制药质量体系(PQS)Highlights the specific requirements of the PQS when applied to sterile medicinal products.强调应用于无菌药品时,PQS的具体要求。
4. Personnel 4.人员Guidance on the requirements for specific training, knowledge and skills. Also gives guidance to the qualification of personnel.有关具体培训、知识和技能要求的指南。
也提供人员确认指南。
5. Premises 5.厂房General guidance regarding the specific needs for premises design and also guidance on the qualification of premises including the use of barrier technology.有关厂房设计的具体需求的总体指南,以及有关厂房确认(包括屏障技术的使用)的指南。
GMP认证文件偏差中英文
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STANDARD OPERATING PROCEDURE 标准操作规程Title : QUALITY DEVIATION MANAGEMENT 题目:质量偏差管理Procedure:编号:Effective Date:生效日期:Supersedes:替代:Review Date:复审日期:Unmodified Review History:Affected Department / Area :受影响的部门/ 区域:1.PURPOSE 目的Whenever a product, material or system fails to meet the specifications or in the event of a failure to comply with relevant documentation or regulatory requirements, an appropriate investigation must be undertaken, the cause(s) identified and the necessary corrective actions taken当产品、物料或系统不符合质量标准要求或某事件不符合相关文件或法规要求时,必须进行适当的调查,查明原因并采取必要的改正措施。
2.SCOPE 范围This SOP covers all failures and unplanned incidents related to Chemical components, Packaging materials, Drug Products, Processes, Systems, Equipments, Utilities and Facilities used to produce and control them.本SOP适用于处理所有失误及非计划性故障事件,含概用于产品并控制产品的化学成分、包装材料、药品、工艺、系统、设备、公共设施和厂房等。
欧盟GMP(中英文对照)
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(The words that are in the green background are new standards)(绿色背景下的内容为新标准)ANNEX 1MANUFACTURE OF STERILE MEDICINAL PRODUCTS附录1 无菌医药产品的生产Principle总则The manufacture of sterile products is subject to special requirements in order to minimize risks of microbiological contamination, and of particulate and pyrogen contamination. Much depends on the skill, training and attitudes of the personnel involved. Quality Assurance is particularly important, and this type of manufacture must strictly follow carefully established and validated methods of preparation and procedure. Sole reliance for sterility or other quality aspects must not be placed on any terminal process or finished product test.无菌药品的生产,必须符合一些特殊的要求,以防止微生物、微粒和热源的污染。
这很大程度上依赖与工作人员的技术水平、培训和工作态度。
在这方面质量保证显得特别重要,这种类型的生产,必须严格按照完善的和经过验证的生产方法和工作程序。
仅靠产品的最终灭菌和某一方面的质量控制是不允许的。
欧洲药典EP8.0 2.6.1无菌检验 sterility中英文翻译
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2.6.1. STERILITY2.6.1 无菌检查法The test is applied to substances, preparations or articles which, according to the Pharmacopoeia, are required to be sterile. However, a satisfactory result only indicates that no contaminating micro-organism has been found in the sample examined in the conditions of the test.本检查方法适用于按照药典要求应当无菌的原料、制剂或其他物质。
但是,如果按照本无菌检查法的结果符合要求,仅表明在该检查条件下未发现微生物污染。
PRECAUTIONS AGAINST MICROBIAL CONTAMINATION微生物污染防The test for sterility is carried out under aseptic conditions. In order to achieve such conditions, the test environment has to be adapted to the way in which the sterility test is performed. The precautions taken to avoid contamination are such that they do not affect any micro-organisms which are to be revealed in the test. The working conditions in which the tests are performed are monitored regularly by appropriate sampling of the working area and by carrying out appropriate controls.无菌检测试验应在无菌的条件下进行。
无菌药品生产商的不符合报告
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无菌药品生产商的不符合报告Non-Compliance reports are published by national competent authoritiesin the EudraGMDP database of the EuropeanMedicines Agency (EMA). They relate to inspections both within andoutside the European Community (European Union). The Non-Compliance reports areentered into the database by the national competent authorities independentlyusing a standardised form. Such a Non-Compliance report has seriousconsequences for the company concerned until the deficiencies have beenrectified. A suspension of the marketing authorisation as well as productrecalls can be ordered.EMA的EUGMDP数据库里由各国药监局负责发布不符合报告,其中包括欧盟境内外的检查。
不符合报告由国家药监使用标准格式独立录入。
这样的不符合报告在缺陷被纠正之前具有严重的后果。
上市许可会被搁置,药品会被要求召回。
On 2nd February 2016, the Spanish competent authoritypublished a Non-Compliance report for theSpanish company Farma MediterraniaS.L. Beside deviations in the areas of secondary packing and QC, considerabledeficiencies with regard to sterile manufacturing have been criticised. One ofthem relates to sterility tests: their results have been accepted uncriticallyalthough no investigation had been performed to determine the root cause ofprevious OOS sterility tests. Furthermore, the following major deficiencieswere found:在2016年2月2日,西班牙药监局公布了一份关于西班牙FARMA公司的不符合报告。
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Deficiencies1、Samples for the release testing (vial filling process) have to be traceable to the sampling time and should be representative for the beginning, middle and end of the filling process. The samples taken have to be tested individuallyand not as a composite sample.用于放行检测的样品(小瓶灌装工艺)必须追溯到取样时间,应该对灌装工艺的开始、中间和结束时间点具有代表性。
必须单独分别检测这些样品,而不能作为组合样品进行检验。
2、During the validation of the newly established Turbometric Endotoxin determination as per EP (Validation plan and report from 29.02.2012) USP Endotoxin standards instead of EP standards were used. A comparison or justification was not performed. During the reviewed Rubber Stopper release testing the USP Endotoxin Standard was used.在根据EP新建立的Turbometric内毒素检测方法验证过程中,采用了USP方法,而不是EP方法。
没有进行对比和论证。
在审核胶塞放行测试中,采用了USP内毒素测试方法。
3. In the master batch records some references to SOPs are needed e.g. the performance of specific environmental monitoring activities were missing.在主批记录中,很多和SOP相关参考文件需要注明,例如特定环境监控活动的表现没有注明。
4. The master batch records are offering in several cases (e.g. filling record page 33 section “Equipment components and primary packaging material check”) only one option – either Yes or No. Please ensure that the operator has the possibility to choose Yes or No-在主批记录中,在几个地方(例如33页灌装记录,设备部件和内包装检查),只是提供了一种原则,或者是yes,或者是no。
请确保操作者有可以选择yes或者no。
5. The disinfectant frequency for the scissor used for opening the PE bags containing e.g. sterile rubber stopper or caps should be increased and described in the related SOP.用于打开PE袋,包括无菌胶塞或者铝盖的剪刀的消毒频率应该提高,并在相关SOP 里面注明。
6. The minimal required exposure time for settle plates (e.g. 1 hour as per ISO or USP recommendation) is not defined in the related SOP.沉降菌最少暴露时间(例如根据ISO标准或者USP建议,采用1小时)没有在相关SOP上面注明。
【翻译者注释】如果审核意见是真实意思的表达,我认为制造商和检查官,都对EU GMP太不熟悉了。
这一点在EU GMP是白纸黑字注明的。
7. There was no written explanation or justification available explaining why for the on-line particle counting (FMS) a deviation will be issued only after an out of acceptance limits of 30 minutes.没有书面解释或者论证来解释:对于在线粒子监控系统,为什么一个偏差只有在超出限度30分钟才被处理?8. On sterilisation printouts the concrete time has to be recorded to calculate the maximal sterile validity period of the related materials. 关于灭菌法,要求必须记录具体时间来计算相关物料的最大有效灭菌周期。
9. The packed and transferred final finished product was not recorded in the staging area inventory list.包装完的转移的最后制剂产品,在集合储存区域,没有被记录在台账清单上。
10. The visual IPC checking of the filled vials should be performed while the vials are rolling.针对灌装完毕的小瓶的目视IPC检查,应该在小瓶旋转时进行检查。
11. The waste bin in the secondary packaging area is insufficient (e.g. size and design) for the intended use.外包装区域的废物桶(例如尺寸和设计)对于目的用途是不足够的。
12. A settle plate in the filling area class B was observed located under an electric panel of the Bosch filling machine. This location seemed unsuitable for the monitoring purpose.在B级灌装区域,发现一个沉降菌测试碟放置在BS灌装机的电子仪表盘上。
这个位置对于监控目的是不合适的。
13. Due to the huge amount of personnel required in the secondary packaging process (~ 10 to 12) a process optimization is requested.因为在外包装工艺需要大量人员(10-12人),需要进行工艺优化。
14. The vial washing machine qualification (IQ, OQ & PQ) documentation should be re-reviewed, restructured and required references / links towards further reports included.安瓿瓶洗涤机验证文件(IQOQPQ)应该被再次审核,再次安装并提供参考文献,包括进一步的报告文件。
【翻译者注释】哪位负责这个文件,估计要倒霉了。
15. Please identify in the personnel monitoring form/ report the body or hand side (right / left) from which the samples are taken.请在人员监控表中注明,身体或者手(左手/右手)取样点,到底从哪个位置取样。
16. The identification of the RRT for known impurity should be included into the Related Substance Test Method.对于已知杂质,RRT的鉴定项目,应该包括在有关物质测试方法中。
RecommendationsThe identification of the particle counter used for active air bourn counting was not mentioned in the summary report attached to the batch records used for batch release. The instrument number was traceable in the related environmental monitoring raw data records. Please add the number to the summary.在用于支持批方形的批记录中汇总表中,没有提到用于测试浮游菌的例子计数器。
这个仪器编号要可以追溯到相关环境监控原始数据记录中。
请在汇总表中加上这个仪器编号。
After IPC the powder from the controlled vials should be collected in a more secure way e.g. in a flask to ensure that the powder won´t beexposed to the packaging area.IPC测试完毕,来自受控小瓶的粉末应该采用更安全的方式来收集,例如使用一个烧瓶来确保粉末不会在包装区域暴露。
Review the individual sections of the Process Risk Assessment with regard to further risk details / sub-sections.结合进一步的风险细节和分支,审核工艺风险评估的单独部分。