Qualification and Validation in EU-GMP / 中国药师

ABSTRACT

Objective:To study the content in the new version of EU-GMP ANNEX 15 (draft) to find the changes of the new and the old version and help the domestic pharmaceutical enterprises meet the requirements of the EU-GMP and complete verification and validation activities.Methods:The new version and the old version of EU-GMP ANNEX 15 were compared,and the changes in the new ANNEX 15 were analyzed in order to understand the changes deeply.Combined with the current implementation status of verification and validation activities in domestic pharmaceutical enterprises,some suggestions on qualification and validation work were provided for domestic pharmaceutical enterprises.Results and Conclusion:The new revision of EU-GMP ANNEX 15 (draft) emphasizes qualification and validation activities during the life cycle of products,and processes,and risk management methods should be used in qualification and validation activities.