SYSTEMATIC REVIEW article
Front. Med.
Sec. Regulatory Science
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1687864
A scoping review of evidence regarding the management of good manufacturing practice inspections
Provisionally accepted
- 1Trinity College Dublin, Dublin, Ireland
- 2King's College London, London, United Kingdom
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Introduction: Regulatory agencies impose stringent legislation and guidelines in the pharmaceutical industry to ensure the safety and quality of medicinal products. While most regulatory research focuses on market authorisation, there are fewer in-depth discussions covering production management. This scoping review explores how Good Manufacturing Practices (GMP) inspections are conducted and identifies best practices for managing them across several phases. Methods: This review adhered to the Joanna Briggs Institute guidance for scoping reviews. The SPIDER technique was utilised for qualitative evidence synthesis to develop the inclusion criteria of this study. The chosen databases were PubMed and Embase (English only, 2015-2025), and grey literature was identified via Google Advanced. Results: Out of 377 sources screened, 74 sources (19.63%) met the inclusion criteria: 14 academic papers and 60 grey literature sources. Thematic analysis identified key strategies for managing GMP inspections across three phases: pre-inspection, execution, and post-inspection. These findings could improve industry compliance, streamline inspection readiness, and reduce uncertainties. These findings are particularly beneficial in low-and middle-income countries where regulatory frameworks are often less evolved. Improving GMP inspection management can contribute to upholding patient safety. Conclusions: GMP inspection management is an unaddressed topic, and further research could deliver value to both regulators and manufacturers. The data in this study identifies recommendations, including a checklist to support GMP inspections, which could be valuable to international manufacturers either in their current state or as a template that can be adapted to specific company contexts. This study underscored the need for advanced inspection methodologies, greater transparency, and strengthening collaboration between regulators and manufacturers to safeguard public health through what we describe as 'Good Inspection Practices'. (GIP)
Keywords: pharmaceutical, good manufacturing practice, Good Inspection Practices, inspection, Management, pharmaceutical industry
Received: 18 Aug 2025; Accepted: 17 Oct 2025.
Copyright: © 2025 Al Azawei, Loughrey, Kim, Connolly and Naughton. 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: Bernard D. Naughton, bernard.naughton@tcd.ie
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.