Gänshirt K H
Biotest-Pharma, Dreieich, Deutschland.
Beitr Infusionsther Transfusionsmed. 1994;32:382-7.
International, European and National laws and guidelines require to establish a Quality Assurance System for manufacturers and distributors of drugs. This includes all departments involved in manufacturing, quality control and distribution. On the basis of validated written Standard Operation Procedures and documentation of all single processes a high standard for the safety of drugs is achieved. In addition, retracing from the finished product lot and the customer back to raw materials and suppliers is possible.
国际、欧洲和国家法律及指南要求为药品制造商和经销商建立质量保证体系。这包括参与生产、质量控制和分销的所有部门。基于经过验证的书面标准操作规程以及所有单个流程的文件记录，可实现药品安全的高标准。此外，从成品批次和客户追溯到原材料和供应商是可行的。
