欧洲药典EP8.0-2.6.1无菌检验-sterility中英文翻译
欧洲药典中英文翻译 EP8.0干燥失重
2.2.32. LOSS ON DRYING 干燥失重Loss on drying is the loss of mass expressed as per cent m/m.干燥失重指重量损失，表述为% 重量/重量Method. Place the prescribed quantity of the substance to be examined in a weighing bottle previously dried under the conditions prescribed for the substance to be examined. Dry the substance to constant mass or for the prescribed time by one of the following procedures. Where the drying temperature is indicated by a single value rather than a range, drying is carried out at the prescribed temperature +/- 2?C.方法：将要求数量的待检样品放置于预先干燥的称量瓶中，按要求条件进行干燥，直至样品干至恒重或下述程序指定的时长。
如果干燥温度给定的是一个值而不是一个范围，则在指定温度+/- 2?C进行干燥。
a) “in a desiccator”: the drying is carried out over diphosphorus pentoxide R at atmospheric atmostpheric pressure and at room temperature;“在干燥器中”：指在室温常压下，用五氧化二磷试剂，进行干燥b) “in vacuo”: the drying is carried out over diphosphorus pentoxide R, at a pressure of 1.5 kPa at room temperature;“真空”：在室温下，真空1.5kPa下，用五氧化二磷试剂进行干燥c) “in vacuo within a specified temperature range”: the drying is carried out over diphosphorus pentoxide R, at a pressure of 1.5kPa to 2.5kPa within the temperature range prescribed in the monograph;“在指定温度范围内真空下”：真空1.5kPa至2.5kPa下，各论要求的温度范围内，用五氧化二磷进行干燥d) “in an oven within a specified temperature range”: the drying is carrie d out in an oven within the temperature range prescribed in the monograph;“在烘箱里指定温度下”：在各论要求的温度范围内，用烘箱进行干燥e) “under high vacuum”: the drying is carried out over diphosphorus pentoxide R at a pressure not exceeding 0.1kPa, at the temperature prescribed in the monograph.“在高真空下”：在各论要求的温度下，不超过0.1kPa的真空下用五氧化二磷进行干燥If other conditions are prescribed, the procedure to be used is described in full in the monograph.如果需要采用其它条件，则在各论中应进行详细描述。
欧洲药典8.0-凡例双语版
1 GENERAL NOTICES凡例1.1 GENERAL STATEMENTS概述The General Notices apply to all monographs and other texts of the European Pharmacopoeia.凡例的内容适用于各论和欧洲药典中的其它章节。
The official texts of the European Pharmacopoeia are published in English and French. Translations in other languages may be prepared by the signatoryStates of the European Pharmacopoeia Convention. In case of doubt or dispute, the English and French versions are alone authoritative.欧洲药典以英语和法语形式发行，欧洲药典委员会的签署国可将药典内容译成其它语言，但若发生争议，应以英语和法语版为权威。
In the texts of the European Pharmacopoeia, the word ‘Pharmacopoeia’ without qualification means the European Pharmacopoeia. The official abbreviation Ph.Eur. may be used to indicate the European Pharmacopoeia.在欧洲药典中，如无特殊规定，“药典”是指欧洲药典，官方缩写 Ph. Eur.也指欧洲药典。
The use of the title or the subtitle of a monograph implies that the articlecomplies with the requirements of the relevant monograph. Such references to monographs in the texts of the Pharmacopoeia are shown using themonograph title and reference number in italics.文章中如果引用了各论中的标题和副标题意味着文章内容符合相关各论的要求。
欧洲药典80纯化水微生物检测译
欧洲药典8.0纯化水微生物检测批量纯化水（区别于装在容器中的纯化水）微生物监测在生产和随后的贮存中，要采取适当措施以确保微生物数量得到适当控制和监测。
要设置适当的警戒限和行动限用于观察不良趋势。
正常条件下，微生物总数的行动限为100 CFU/mL，用薄膜过滤法，滤膜孔径不得过0.45μm，使用R2A琼脂培养基，于30-35℃培养不少于5天。
样品量的选择应与期望的检测结果相关联。
R2A琼脂培养基培养基灭菌后，调节pH7.2±0.2。
灭菌方式：高压灭菌锅，121℃、15分钟。
R2A琼脂培养基促生长试验- 试验菌株制备。
使用标准化的稳定的试验菌悬浮液，或按表0008-1所述配制。
试验用菌株的传代不得超过5代，从菌种保藏中心获得的原始菌株算起。
按表0008-1所述，每个菌株分开培养。
使用pH7.0氯化钠-蛋白胨缓冲液或pH7.2磷酸盐缓冲液配制试验菌悬浮液。
试验菌悬浮液配制好后，应在2小时内使用，或存于2-8℃于24小时内使用。
作为一种替代方法，可以配制然后稀释枯草芽孢杆菌（Bacillus subtilis）生长细胞的新鲜悬浮液：配制一个稳定的孢子悬液，然后使用适当体积的孢子悬液用于试验接种。
孢子悬液可在2-8℃贮藏，贮藏时间要经过验证。
- 促生长。
每批已配制好的培养基都要做促生长试验，不管是使用脱水培养基（干粉）配制，还是使用上述的成分配制。
将表0008-1所述的微生物取少量（不超过100CFU），单独接种至含R2A琼脂培养基的平皿中，按表中所述的条件培养。
培养后观察到的微生物结果不得超过理论值±2倍。
针对新配制的接种体，微生物促生长试验结果必须与之前试验过、批准过的培养基结果做对比。
表0008-1R2A琼脂促生长试验微生物试验菌株制备促生长条件。
欧盟GMP-术语-中英文版
GLOSSARY术语Definitions given below apply to the words as used in this guide. They may have different meanings in other contexts.以下所列定义适用于本指南中所用词汇，在其他上下文中同一术语的涵义可能不同。
AIR-LOCK气锁An enclosed space with two or more doors, and which is interposed between two or more rooms, e.g. of differing class of cleanliness, for the purpose of controlling theair-flow between those rooms when they need to be entered. An air-lock is designed for and used by either people or goods.设置于两个或数个房间之间(如不同洁净级别的房间之间)的具有两扇或多扇门的隔离空间。
设置气锁的目的是在人员或物料出入其间时，对气流进行控制。
气锁有人员气锁和物料气锁之分。
BATCH (OR LOT)批A defined quantity of starting material, packaging material or product processed in one process or series of processes so that it could be expected to be homogeneous.由一个或若干加工过程生产的具有预期均一质量和特性的一定数量的原辅料、包装材料或药品。
NoteTo complete certain stages of manufacture, it may be necessary to divide a batch into a number of sub batches, which are later brought together to form a final homogeneous batch. In the case of continuous manufacture, the batch must correspond to a defined fraction of the production, characterised by its intended homogeneity.注：为完成某些生产操作步骤，可能有必要将一批分成若干亚批，然后再合起来成为一个最终均一的批。
ep8.02.6.13非无菌药品的微生物限度检查：特殊微生物的检查(中英对照)
EP 8.004/2010:20613 MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS: TEST FOR SPECIFIED MICRO-ORGANISMS(3)非无菌药品的微生物限度检查：特殊微生物的检查1. INTRODUCTION 导言The tests described hereafter will allow determination of the absence or limited occurrence of specified micro-organisms that may be detected under the conditions described.下述检验方法用于检查在描述的试验条件下特定微生物的定性及限度。
The tests are designed primarily to determine whether a substance or preparation complies with an established specification for microbiological quality. When used for such purposes, follow the instructions given below, including the number of samples to be taken, and interpret the results as stated below.检验的主要目的是为了确定是否原料药或制剂符合已建立的微生物限度标准，当用于这一目的时，应按照以下方式（包括取样量），进行并按照下述描述对结果进行分析。
Alternative microbiological procedures, including automated methods, may be used, provided that their equivalence to the Pharmacopoeia method has been demonstrated.如果可证明某种试验方法（包括自动化分析法）的效果与药典中的方法等同，该方法可作为另一种供选择的试验方法。
欧盟GMP中英文对照
实用文档European Union药品生产质量管理规范GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS目录第一章质量管理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)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)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)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)Starting materials (64)包装材料 (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-中英文对照[1]
![EUGMP-中英文对照[1]](https://img.taocdn.com/s3/m/a56c582fd1f34693dbef3e0d.png)
EU GMP ANNEX 1 MANUFACTURE OF STERILE MEDICINAL PRODUCTS （中英文对照）(a) These are average values. （一）这些都是平均值。
(b) Individual settle plates may be exposed for less than 4 hours. （二）单个沉降皿放置的时间可以少于4小时。
20. Appropriate alert and action limits should be set for the results of particulate and microbiological monitoring. If these limits are exceeded operating procedures should prescribe corrective action。
对尘埃粒子和微生物的监控结果，要设置适当的警戒限度和行动限度。
当超出这些限度时，操作规程应说明需要采取的措施。
Isolator technology 隔离技术21. The utilisation of isolator technology to minimize human interventions in processing areas may result in a significant decrease in the risk of microbiological contamination of aseptically manufactured products from the environment. There are many possible designs of isolators and transfer devices. The isolator and the background environment should be designed so that the required air quality for the respective zones can be realised. Isolators are constructed of various materials more or less prone to puncture and leakage. Transfer devices may vary from a single door to double door designs to fully sealed systems incorporating sterilization mechanisms. 在生产区采用人员方面的隔离技术，在无菌产品的生产中，会显著降低周围环境微生物污染的风险。
欧盟GMP附录1(征求意见稿)无菌药品-中英文对照
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。
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2.6.1. STERILITY
2.6.1 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
微生物污染防范
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。
为了达到这样的条件，检测环境应当与无菌检测的操作要求相适应。
避免污染的防范措施应当不对本检查方法进行检测的微生物造成影响（应并不影响用本检查法检测的微生物）。
通过对工作区域的适当取样以及进行适当的控制来对无菌检查的工作环境进行例行监测。
CULTURE MEDIA AND INCUBATION TEMPERATURES
培养基和培养温度
Media for the test may be prepared as described below, or equivalent commercial media may be used provided that they comply with the growth promotion test.
应按下面描述的方法制备无菌检查的培养介质，如果满足生长促进试验要求，与本处所述培养基相当的商业化培养基也可以采用（也可采用与本处……）。
The following culture media have been found to be suitable for the test for sterility. Fluid thioglycollate medium is primarily intended for the culture of
anaerobic bacteria; however, it will also detect aerobic bacteria. Soya -bean casein digest medium is suitable for the culture of both fungi and aerobic bacteria.
下述的培养基已被证明（经证明）适用于无菌检查。
硫乙醇酸盐流体培养基主要用于厌氧菌培养，但是，也适用于需氧菌检测。
大豆酪蛋白消化物培养基适用于真菌和需氧菌培养。
and pancreatic digest of casein with the water R and heat until solution is effected.。