论药品生产企业质量管理标准问题

On the Criterion of Quality Management in Pharmaceutical Enterprises

本文论述了什么是质量管理，指出GMP不是质量管理，只是质量管理的一部分。不能用GMP作为质量管理的标准。制药企业应以ISO9000族标准为质量管理和质量保证的标准，并把GMP与ISO9000结合起来。

This article describes what quality management is,and points out that GMP is not equal to quality management andis only part of it.GMP can't be used as the criterion of quality management.ISO 9000 family,combined with GMP,should be used asthe quality management and insurence criterion in pharmaceutical enterprises.