为什么质量管理是制药企业GMP管理的核心?
GMP
推荐回答(3个)
给你些有帮助的资料看看吧:
将“安全、有效、质量”的药品监管原则系统地融入到规范中
重点突出
药厂必须按注册批准的工艺进行生产
药厂必须按注册批准的质量标准和检验方法进行检验
药厂必须采用注册批准的原辅料和与药品直接接触的包装材料
质量标准
来源
GMP检查是整个药品监管承上启下的一个重要环节
以注册为依据对产品进行检查
与上市后药品的安全监管相联系
系统 现状 对策
质量保证系统 QA定位不清楚
没有建立系统的QA工作流程(变更控制、偏差处理)
质量信息系统(KPI系统、系统回顾)
CAPA机制没有建立 关键流程的建立
QA人员的补充与培训
质量信息数据库的建立
实验室控制 取样管理严谨性不够
质量标准与方法学验证没有有效实施
OOS没有有效实施
稳定性实验管理有效性不够 实验室控制的关键流程建立
取样管理
质量文件管理
方法学验证
OOS管理
质量管理是法律法规、顾客期望与要求、组织目标、组织硬件环境与人的有机结合的过程(策划、控制、协调)
没有有效的管理,一切只是死的物件,没有生机和希望。
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