The World Health Organization (WHO) developed the Quality Assurance of Pharmaceuticals Compendium, Volume 2, to ensure the quality, safety and effectiveness of medicines, focusing on good manufacturing practices (GMP) and related guidelines.
This summary provides an overview of the key features and updates in the latest edition.
The Compendium is a valuable tool for countries to establish robust regulatory systems and uphold international standards in pharmaceutical quality assurance. It consolidates essential recommendations and guidelines related to GMP in a structured manner, facilitating easy access to vital information.
Despite global efforts to ensure the availability of quality medicines, substandard and falsified products still pose challenges in healthcare delivery in many countries.
To address this issue, WHO’s Expert Committee on Specifications for Pharmaceutical Preparations has made numerous recommendations to establish standards, guidelines and promote effective regulatory and control systems.
The GMP Compendium for Medical Products guides the manufacturing and quality control of pharmaceuticals, vaccines, biologicals and other medical products. It aims to ensure the quality, safety and efficacy of these products which are crucial for preventing and treating diseases and improving global health.
The latest edition of the Compendium features several updates and new texts to ensure the recommendations are fit-for-purpose and current. It now includes fortyfive guidelines covering topics related to GMP and the inspection of pharmaceutical manufacturers and distribution channels. Among these guidelines, ten have been revised to incorporate the latest advancements and address emerging challenges in the pharmaceutical industry, while eight new guidelines have been introduced to address previously unexplored areas. These new topics include GMP for investigational radiopharmaceuticals and medicinal gases, recommendations on environmental aspects for the prevention of antimicrobial resistance, health-based exposure limits in cleaning
validation and good practices for research and development facilities.
The Compendium is organized into sections: GMP main principles, starting materials, specific medical products, related guidelines, laboratory guidelines and inspections. Each section offers detailed advice and comprehensive coverage of pharmaceutical quality assurance.
The guidelines within the Compendium align with internationally recognized texts and establish acceptable international standards. However, they allow for necessary adaptations to address unique conditions in individual countries as long as deviations are validated for equivalence.
Emphasizing the importance of inspections in enforcing GMP compliance, licensing and maintaining product quality throughout distribution channels, the
Compendium helps combat the challenges posed by substandard and falsified medicines.
It provides guidance on inspecting manufacturing facilities, drug distribution channels and conducting pre-approval inspections. Furthermore, it highlights the growing significance of implementing quality systems not only in pharmaceutical manufacturing facilities but also within pharmaceutical inspectorates.
The tenth edition of the GMP Compendium builds upon the success of the previous edition, incorporating revised guidelines to reflect the latest developments and introducing new guidelines to address emerging needs. It is an indispensable resource for regulatory authorities, pharmaceutical manufacturers and other stakeholders involved in ensuring the quality, safety, and efficacy of pharmaceutical products.