EU-GMP 附录一 翻译搞.doc

ANNEX 1 附件1
MANUFACTURE OF STERILE MEDICINAL PRODUCTS
无菌医药产品的生产
Principle 原则
The manufacture of sterile products is subject to special requirements in order to minimise 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。这很大程度上要依赖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。
Note:
This guidance does not lay down detailed methods for determining the microbiological and particulate cleanliness of air, surfaces etc. Reference should be made to other documents such as the EN/ISO Standards.
注:本规范没有详述测定空气、表面等微生物和微粒洁净度的详细方法,请参阅EN/ISO中相关标准。
General 一般要求
1. The manufacture of sterile products should be carried out in clean areas entry to which should be through airlocks for personnel and/or for equipment and materials. Clean areas should be maintained to an appropriate cleanliness standard and supplied with air which has passed through filters of an appropriate efficiency.
无菌产品的生产要在洁净区域内进行,进入这些区域内的人员、设备或原料,必须通过气闸室。洁净区必须保持一定的洁净级别,空气必须通过规定的过滤器。
2. The various operations ponent preparation, product preparation and filling should be carried out in separate areas within the clean area. Manufacturing operations are divided into two categories; firstly those where the product is terminally sterilised, and secondly those which are conducted aseptically at some or all stages.
各种原料的准备、产品的准备和灌装,必须在洁净区的不同区域进行,生产操作分为两类,一是最终灭菌型,二是部分过程或全过程的无菌操作。
3. Clean areas for the manufacture of sterile products are classified according to the required characteristics of the environment. Each manufacturing operati