GMP is a fundamental concept in pharmaceutical manufacturing and distribution. Poor-quality medicinal products can lead to adverse effects, treatment failure, and even death. Implementing GMP assures that pharmaceutical products are produced with the highest quality standards. Despite having stringent GMP guidelines in place, GMP-related mishaps still occur today. The recent GMP disaster resulting from the contamination of cough syrups in the Gambia, Indonesia, and Uzbekistan that led to the deaths of children is one such unfortunate example.
This is where the GMP compendium for medicinal products comes in:
On 29 January 2024, WHO hosted a launch event for the Tenth Edition of the WHO Good Manufacturing Practices (GMP) Compendium and Related Guidelines.
Entitled “Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials; Tenth Edition, Volume 2, the comprehensive publication includes new additions, along with updates to some old guidelines.
Whether you’re a healthcare professional, regulatory affairs specialist, quality assurance professional, pharmaceutical manufacturer, GMP inspector, or anyone committed to ensuring pharmaceutical products' quality, safety, and efficacy, staying up-to-date with the latest GMP updates is indispensable.
The WHO GMP compendium consolidates all essential recommendations and guidelines of the World Health Organization (WHO) related to good manufacturing practices (GMP) and inspections, in a structured manner within one publication. It covers various fundamental GMP topics including quality management systems, personnel hygiene, equipment validation, and complaint handling based on the latest scientific and technical knowledge available.
In this article, we’re dissecting and briefly reviewing the forty-six guideline-long GMP compendium by WHO.
So without further ado, let’s get started!
Overview of Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials; Tenth Edition, Volume 2
The latest edition of the WHO Compendium of GMP guidelines is curated as a one-stop solution that eliminates the need to consult multiple texts by bringing all existing and newly updated WHO guidelines, recommendations, and annexes into a single document.
The compendium includes forty-six guidelines covering different aspects of GMP, quality assurance, and inspections. It guides the readers in inspecting pharmaceutical manufacturing facilities and distribution channels, conducting inspections, and implementing quality systems.
There are three main aspects of pharmaceutical GMP covered in the guideline - manufacturing, regulatory compliance, and quality control, which can be used as valuable tools to establish regulatory systems and maintain compliance with international standards in pharmaceutical quality assurance.
The Contents page of the compendium contains five introductory sections and six dedicated GMP sections for each aspect of GMP. Following is the breakdown of the contents section:
Foreword
Acknowledgments
Abbreviations and Acronyms
Executive Summary
Introduction
1. WHO good manufacturing practices: main principles for pharmaceutical products
2. WHO good manufacturing practices: starting materials
3. WHO good manufacturing practices: specific medical products
4. Related guidelines
5. Laboratory guidelines
6. Inspections
Each of the above six numbered sections discusses detailed guidelines for pharmaceutical products, starting materials, specific medical products, and more.
Updates to the Compendium
New Additions
Following are the new additions published in the updated compendium:
· Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation: Annex 2, WHO Technical Report Series, 1033, 2021
· Production of water for injection by means other than distillation: Annex 3, WHO Technical Report Series, 1025, 2020
· WHO good manufacturing practices for medicinal gases: Annex 5, WHO Technical Report Series, 1044, 2022
· IAEA - WHO guideline on go...
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