欧盟GMP关于菌室要求.docVIP

ANNEX 1 MANUFACTURE OF STERILE MEDICINAL PRODUCTS 附录01-无菌药品制造(2008版) Principle原则 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. 无菌药品制造条件,以使得微生物,微粒和热源污染的风险最小。其 很大程度上要取决于所涉及到人员技术水平,培训与态度。质量保证特别重要,必须严格遵守小心建立的并经过验证的生产方法和工作程序。不能单独依 靠无菌与其它质量方面测试来取代最终过程或成品测试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: 本指南没有制订测定空气,表面等微生物与微粒洁净度的详细方法。请参阅例如 EN/ISO标准的其它文件。 General总则 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. 无菌产品制造应当在洁净区域内进行,进入这些区域内的人员和/或设备与物 料,应当通过气闸室。洁净区必须保持一定的洁净级别标准,空气必须通过适当 效率过滤器供给。 2. The various operations of component 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. 各种部件准备,产品准备与灌装,应当隔离的洁净区进行。制造操作分为两类, 第一类是产品最终灭菌型,第二类是部分过程或全过程的无菌操作型。 3. Clean areas for the manufacture of sterile products are classified according to the required characteristics of the environment. Each manufacturin