AUTHOR=Al Azawei Aisha , Loughrey Kate , Surim Kim , Connolly Mary Elizabeth , Naughton Bernard D. 

TITLE=The management of good manufacturing practice (GMP) inspections: a scoping review of the evidence

JOURNAL=Frontiers in Medicine

VOLUME=Volume 12 - 2025

YEAR=2025

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1687864

DOI=10.3389/fmed.2025.1687864

ISSN=2296-858X

ABSTRACT=IntroductionRegulatory 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 authorization, 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.MethodsThis review adhered to the Joanna Briggs Institute guidance for scoping reviews. The SPIDER framework was utilized 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.ResultsOf 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.ConclusionGMP inspection management is an unaddressed topic, and further research could deliver value to regulators and manufacturers. The data in this paper offers recommendations, including a checklist to support GMP inspections, which may be useful to international manufacturers either in its current state or as a template that can be adapted to specific company contexts. This study highlights the need for advanced inspection methodologies, greater transparency, and stronger collaboration between regulators and manufacturers to safeguard public health through what we describe as ‘Good Inspection Practices’(GIP).