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

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

SUBMITTER: Al Azawei A 

PROVIDER: S-EPMC12645793 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature