实施2010版GMP对企业质量管理理念的影响

目的针对2010版GMP关于质量管理的新要求,结合实施新版GMP过程的实际,对企业质量管理理念进行探讨。方法采用归纳的方法,阐述我国2010版GMP出台的必要性;通过对比分析表明,旧的质量管理理念存在的不足和2010版GMP质量管理理念的科学性。结果企业应建立健全质量风险管理和质量源于设计的新科学质量管理理念。结论科学的质量管理理念是切实保障产品质量,提高产品和企业竞争力的有效手段。

Effects of 2010 GMP on the quality management conceptions within the enterprise

Objective According to the new requirements for quality management of 2010 GMP,combined with the ac- tual process of implementing the new version of GMP, carried on the discussion to the quality management conception within the enterprise. Methods Using the inductive method, explaining the necessity of the 2010 edition of GMP China promulga- ted ; By comparing, the old concept of quality management had defects and the 2010 version of GMP quality management phi- Josophy was scientific. Results Enterprises should establish and perfect the new scientific quality management conceptions of the quality risk management and quality by design. Conclusion Scientific quality management conceptions were effec- tive ways to ensure the quality of the products and improve the competitiveness of products and enterprise.