Design of the Quality System for Pharmaceutical Commissioned Production under MAH System

Abstract

Objective To ensure the quality and safety of drugs in the whole cycle of pharmaceutical commissioned production under the drug marketing authorization holder (MAH) system, and to establish a perfect quality management system for it. Methods Literature review was used to study the factors that influenced the quality management system of pharmaceutical commissioned production because the implementation of MAH system in China was late, and the experience accumulated by pharmaceutical industry was not enough. Results and Conclusion Based on the MAH system, it is of great significance to establish the quality management system for pharmaceutical commissioned production.

Keywords

MAH / marketing authorization holder / quality management system

References

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