无菌药品（Sterile drug）.doc

无菌药品（Sterile drug） Appendix 1: Sterile drug Chapter 1 Scope The term sterile drug refers to the preparation and API of the items listed in the statutory drug standards, including sterile preparations and sterile raw materials. Second this appendix applies to the whole process of aseptic preparation and sterilization and aseptic production of sterile raw materials. Second chapter principle The production of third sterile drugs shall meet the requirements of their quality and intended use, and the contamination of microorganisms, particulates and pyrogen shall be reduced to the greatest extent. Training production staff skills, accept and work attitude are the key factors to achieve the above objectives, the manufacture of sterile products must be validated methods and procedures in strict accordance with the elaborate design and final processing or finished product test sterility or other quality characteristics can not only rely on any form of (including sterility test). Fourth aseptic drugs can be divided into two groups according to the production process: the final sterilization product is the final sterilization process, and some or all of the procedures are sterile products and non final sterilization products. Fifth personnel, equipment and materials produced by aseptic drugs should enter the clean area through the air lock and use mechanical continuous transmission to protect the material and monitor the pressure difference. Sixth materials preparation, product preparation and filling or packing must be done in the clean area (room). The seventh shall determine the level of clean zones for the production of sterile drugs in accordance with product characteristics, processes and equipment. Every step of the operation shall be governed by an appropriate dynamic cleanliness standard, minimizing the risk of contamination of the product or the material to be contaminated by particulates or microorganisms. The third chapter: cleanliness grade and monitoring The des