亚洲社会药学 ›› 2023, Vol. 18 ›› Issue (4): 345-351.

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Introduction of PIC/S Accession Procedure and Suggestions for Establishing a Unified Quality Management System in China

  

  • 出版日期:2023-12-20 发布日期:2023-12-19

Introduction of PIC/S Accession Procedure and Suggestions for Establishing a Unified Quality Management System in China

  • Online:2023-12-20 Published:2023-12-19

摘要: Objective To introduce the accession procedure and evaluation of PIC/S, and help relevant departments in China to understand the requirements of PIC/S in detail, and to promote the process of China’s entry into PIC/S. Methods The procedures and steps of joining PIC/S, the evaluation process of PIC/S, and the experience of several countries in joining PIC/S were introduced and analyzed, which could help the relevant personnel in China understand the specific contents. Results and Conclusion According to the requirements of PIC/S, it is necessary to establish a unified GMP quality management system.

关键词: PIC/S, GMP, accession procedure, quality management system

Abstract: Objective To introduce the accession procedure and evaluation of PIC/S, and help relevant departments in China to understand the requirements of PIC/S in detail, and to promote the process of China’s entry into PIC/S. Methods The procedures and steps of joining PIC/S, the evaluation process of PIC/S, and the experience of several countries in joining PIC/S were introduced and analyzed, which could help the relevant personnel in China understand the specific contents. Results and Conclusion According to the requirements of PIC/S, it is necessary to establish a unified GMP quality management system.

Key words: PIC/S, GMP, accession procedure, quality management system