COSTCO验厂质量GMP审核常见的几个问题

最近给大家分享了众多关于COSTCO验厂GMP质量审核方面的标准内容，那么今天就给大家带来在审核中几大常见的易出问题的地方

Employees are not familiar withfactoryquality and products safety policy.

1. 员工不了解工厂的质量和产品安全方针;

Only several departments have establishedmeasurable quality objectives. No regular monitoring of the achievement ofQuality objectives. There is no root causes or improvement actions whenobjectives are not achieved.

2. 只有个别部门有设定质量可测量的目标；未定期考核目标的执行情况。当目标未达到时，无相应的原因分析和改善方案。

Internal audit and management review do notinclude the content related GMP.

3. 内审和管理评审未包括GMP方面；

The external documents lists are not complete,such as Client‘s requirements, Laws and Regulations of products sale markets,product related standard, etc are not listed and under controlled distribution.

4. 工厂的外来文件清单不完整，比如缺客户标准、产品销售地相关法规标准，产品标准等，且未按受控要求发放。

Risk assessment is not complete, such as nodocumented risk assessment procedure, risk assessment records do not includephysical(sharp tool, glass)，chemical (heavy metal) orbiological(pest, mould) contamination during the production, packaging orstorage processes, no control method, no responsible person, etc

5. 风险评估不完整，比如：缺程序，记录不完整（生产，包装或存储过程中物理，化学，生物方面对产品的污染），控制措施，人员的职责等