WHO's Newest Updates in Pharmaceutical GMP Guidelines

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 good manufacturing practices for investigational radiopharmaceutical products: Annex 3, WHO Technical Report Series, 1044, 2022

· WHO good practices for research and development facilities of pharmaceutical products: Annex 3, WHO Technical Report Series, 1044, 2022

· Points to consider for manufacturers and inspectors: environmental aspects of manufacturing for the prevention of antimicrobial resistance: Annex 3, WHO Technical Report Series, 1025, 2020

· Good chromatography practices: Annex 4, WHO Technical Report Series, 1025, 2020

 Revisions

 The following guidelines in the compendium have been revised:

· Good manufacturing practices: water for pharmaceutical use. Annex 3, WHO Technical Report Series, 1033, 2021

· WHO good manufacturing practices for sterile pharmaceutical products. Annex 2, WHO Technical Report Series, 1044, 2022

· International Atomic Energy Agency and World Health Organization guideline on good manufacturing practices for radiopharmaceutical products: Annex 2, WHO Technical Report Series, 1025, 2020

· WHO good manufacturing practices for investigational products: Annex 7, WHO Technical Report Series, 1044, 2022

· WHO guidelines on technology transfer in pharmaceutical manufacturing: Annex 4, WHO Technical Report Series, 1044, 2022

· Guideline on data integrity: Annex 4, WHO Technical Report Series, 1033, 2021

· Guidelines on the implementation of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce: Annex 9, WHO Technical Report Series, 1033, 2021

· Good storage and distribution practices for medical products: Annex 7, WHO Technical Report Series, 1025, 2020

· Quality management system requirements for national inspectorates: Annex 5, WHO Technical Report Series, 1025, 2020

Conclusion 

The latest updates to the WHO Good Manufacturing Practices (GMP) Compendium and Related Guidelines mark a significant stride towards ensuring the quality, safety, and efficacy of pharmaceutical products worldwide. With the unfortunate incidents of GMP-related mishaps, such as the recent contamination of cough syrups leading to tragic outcomes, it has become increasingly crucial to have stringent standards in place for pharmaceutical manufacturing and distribution. 

The Tenth Edition of the WHO GMP Compendium serves as a comprehensive resource, bringing together essential recommendations and guidelines in a structured manner. By consolidating existing guidelines and incorporating new additions and revisions, this edition equips professionals across various domains - from healthcare practitioners to regulatory affairs specialists - with the necessary tools to assure GMP compliance across the pharmaceutical sector. 

From quality management systems to laboratory guidelines, the compendium addresses key aspects for maintaining compliance with international standards. As the pharmaceutical industry continues to evolve, staying abreast of these updates is ensures that medicinal products meet the highest standards of quality and safety, ultimately benefiting global public health.

The Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials; Tenth Edition,  Volume 2 is available here.

About the Author:

Saher Binte Haider

Saher Binte Haider is a pharmacy graduate from Dow University of Health Sciences. She started her career as a Quality Management professional in the pharmaceutical industry where she developed a keen interest in good documentation practices, SOP creation, and content writing. She has 7+ years of experience in healthcare & life sciences content writing. Her key areas of expertise are healthcare, pharmaceuticals, health tech, and AI in healthcare.