Evidence map›Paper›PMID 41306493›Full record

SynthesisFrontiers in medicine2025

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

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

Abstract readSystematic Review
In one paragraph

Synthesis in Frontiers in medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Aisha Al AzaweiSchool of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin, Ireland.
Kate LoughreySchool of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin, Ireland.
Kim SurimSchool of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin, Ireland.
Mary Elizabeth ConnollySchool of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin, Ireland.
Bernard D NaughtonSchool of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin, Ireland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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).

Indexed as

GMPgood inspection practicesgood manufacturing practiceinspectionmanagementpharmaceuticalpharmaceutical industrypharmaceutical quality

Identifiers

PMID41306493
PMCPMC12645793

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.