浅谈药品生产企业验证管理

Discussion on the Verification and Management of Drug Production Enterprises

药品直接关系到人们的身体健康甚至生命存亡,所以说药品的质量不得有半点马虎。药品生产企业必须确保药品的安全、有效、均一、稳定。根据GMP要求,药品生产过程中验证活动是必需的,起着举足轻重的作用。因此药品生产企业要进行系统的验证管理工作。验证不是工艺研发、不是工艺优化、也不是生产环境的测试,是符合GMP原则的校对,也就是对工艺过程、设备、物料、系统实际上导致的预期结果。验证研发要强化GMP,遵循既定的程序执行,将结果进行记录。

Drugs are directly related to people＇s health and even their lives, so the quality of drugs should not be a bit careless. So the quality of drugs should not be careless. Drug production enterprises must ensure the safety, effectiveness, uniformity and stability of drugs. According to GMP requirements, verification activities are necessary and play a pivotal role in drug production process. Therefore, drug production enterprises should conduct systematic verification and management work. Verification is not the process research and development, not the process optimization or the test of the production environment, it is the proofreading in line with GMP principles, that is, the expected results actually caused by the process, equipment, materials and systems. The verification and research should strengthen GMP and follow established procedures and make a record for the results.