The management of good manufacturing practice (GMP) inspections: a scoping review of the evidence
School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin
How they used Delve
Pharmacy researchers at Trinity College Dublin and King's College London used Delve to code 74 academic papers and grey literature documents for a scoping review of pharmaceutical GMP inspections, generating themes inductively and grouping them by inspection phase to produce a 'Good Inspection Practices' checklist for manufacturers.
“Thematic analysis was used to synthesize academic and grey literature findings. The data were coded using Delve, a qualitative analysis software. Main themes were generated inductively and grouped according to the phases of GMP inspections (pre-inspection, execution, and post-inspection). These were further refined into subthemes for deeper analysis of practices, challenges, and opportunities related to GMP inspection management.”
- Field
- Pharmaceutical regulatory science; how good manufacturing practice inspections are run and managed across the pre-inspection, execution and post-inspection phases
- Data
- 74 sources retained from 377 screened - 14 peer-reviewed academic papers and 60 grey literature documents (regulatory guidance and reports, largely UK, EU and US) - drawn from PubMed, Embase and Google Advanced, English only, 2015-2025
- Approach
- Scoping review following Joanna Briggs Institute guidance, with the SPIDER framework setting the inclusion criteria and the MMAT used for quality appraisal. Evidence synthesis was a thematic analysis: main themes generated inductively, grouped by the three phases of a GMP inspection, then refined into subthemes covering practices, challenges and opportunities.
- Data types
- Documents
Abstract
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 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. Methods: This 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. Results: 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. Conclusion: GMP 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).
Citation
Aisha Al Azawei, Kate Loughrey, Kim Surim, Mary Elizabeth Connolly, Bernard D. Naughton (2025). The management of good manufacturing practice (GMP) inspections: a scoping review of the evidence. Frontiers in Medicine. https://doi.org/10.3389/fmed.2025.1687864