ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Drugs Outcomes Research and Policies
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1559004
Key Elements and Theoretical Logic of Application of PIC/S Standards in Improving Drug GMP Inspections in China: An Analysis Based on Grounded Theory
Provisionally accepted
- 1Shenyang Pharmaceutical University, Shenyang, China
- 2Shanghai Drug Evaluation and Verification Center, Shanghai, China
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Objective Currently, China regulatory authorities are committed to improving drug inspection by learning from international advanced experiences, such as the Pharmaceutical Inspection Co-operation Scheme (PIC/S), to boost the development of the pharmaceutical industry. In the past, there has been a lack of systematic discussion and comprehensive theoretical construction of the key elements affecting the improvement of China's Good Manufacturing Practice (GMP) inspection. Through this study, the key elements and theoretical logic for applying PIC/S standards to improve China's pharmaceutical GMP inspection work are constructed. Methods This study uses diverse data and applies grounded theory to construct a model , systematically presenting the key elements and theoretical logic of applying PIC/S standards in improving GMP inspections in China. Results The study found that international recognized GMP regulations are external contextual elements, while internal driving elements include professionalization and specialization of inspectors , standardized inspection procedures, and maintain consistent quality levels. The internal dimensions of these four elements are independent, but they can not only individually influence but also partially overlap and have a combined impact . Moreover, professionalization and specialization of inspectors, standardized inspection procedures, and maintain consistent quality levels have a dynamic, cyclical promoting effect on the application of PIC/S standards. Conclusions Based on China's national conditions, this study deepens the theoretical framework and content of applying PIC/S standards to improve drug GMP inspections, providing a reference for public sectors to enhance the effectiveness of pharmaceutical regulation.
Keywords: PIC/S, China Drug GMP Inspection, grounded theory, Inspectors, Inspection procedures, Inspection Mutual Trust
Received: 13 Jan 2025; Accepted: 01 Jul 2025.
Copyright: © 2025 Hu, Liao and Chen. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Yuwen Chen, Shenyang Pharmaceutical University, Shenyang, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.