制药企业QC实验室CNAS体系与其他质量体系融合的探讨

Discussion on the integration of CNAS system and GMP and other quality systems in QC laboratories of pharmaceutical enterprises

制药企业QC实验室实施《药品生产质量管理规范》(GMP)管理是药品管理法规要求,同时实施CNAS或ICH Q10或ISO9001,能够进一步提升实验室的管理水平。本文比较了CNAS、GMP、ICH Q10和ISO9001体系的主要特点,阐述了制药企业QC实验室在企业中的地位及与相关部门的关联性,在同时实施CNAS、GMP、ICH Q10和ISO9001等多个体系时,必须充分理解和把握各体系的要求,梳理出共性要求和个性化要求,有针对性的采取措施,可以采用相互依托、互为补充的策略,将各体系有机结合、融为一体。

Implementing GMP management in QC laboratories of pharmaceutical enterprises is the requirement of drug management regulations.At the same time,the implementation of CNAS or ICH Q10 or ISO9001 can further improve the management level of laboratories.This paper compared the main characteristics of CNAS,GMP,ICH Q10 and ISO9001 systems,and expounded the position of QC laboratory in pharmaceutical enterprises and its relevance with relevant departments.When implementing multiple systems such as CNAS,GMP,ICH Q10 and ISO9001 at the same time,we must fully understand and grasp the requirements of each system,sort out the common and personalized requirements,take targeted measures,and adopt the strategy of relying on and complementing each other,Organically combine and integrate all systems.