Overview
In February 2024, the World Health Organization (WHO) released the 10th edition of its authoritative reference work: Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials – Volume 1: Good Practices and Related Regulatory Guidance.
This publication is a key resource for those working to ensure the quality, safety, and efficacy of pharmaceutical products—whether through regulatory oversight, quality assurance systems, or manufacturing best practice.
The Compendium provides clear and comprehensive guidance on Good Manufacturing Practices (GMP) and related regulatory expectations. It’s particularly relevant in the context of increasing global concerns around medicine shortages, falsified products, and variable GMP enforcement across markets.
This 10th edition introduces eight new guidelines and revises 10 others, bringing the total number of documents covered to 46.
Key Focus Areas in the 10th Edition
Good Manufacturing Practices (GMP)
The compendium reaffirms GMP as the foundation of pharmaceutical quality systems. It outlines expectations for facilities, equipment, personnel training, process control, documentation, and deviation management—all essential to maintaining consistent, safe, and effective production across diverse manufacturing contexts. Updates include modernised terminology and increased emphasis on quality risk management.
Starting Materials
New and updated guidelines address the sourcing, control, and traceability of active pharmaceutical ingredients (APIs) and excipients. This section highlights the importance of supplier qualification and testing of starting materials to prevent contamination, substitution, or variability—critical in maintaining product efficacy and patient safety.
Specific Medical Products
Dedicated guidance is provided for the manufacture of high-risk product types, including sterile injectables, biologics, blood products, and medicinal gases. These products require enhanced process controls, sterility assurance strategies, and dedicated facility design considerations—all of which are addressed in detail.
Laboratory Guidelines
The compendium outlines best practices for quality control (QC) laboratories, including the qualification of analytical instruments, validation of methods, and requirements for reference standards. It also covers good documentation practices and internal audit expectations to ensure reliability and regulatory compliance in product testing.
Inspections
The revised guidance sets out a clear framework for GMP inspections, including planning, execution, and post-inspection follow-up. Emphasis is placed on risk-based inspection scheduling, inspector training, and harmonised inspection methodologies. These updates support regulators in strengthening compliance monitoring and early identification of systemic quality issues.
Responding to Emerging Industry Challenges
In addition to core guidance, the compendium addresses evolving areas of concern within pharmaceutical manufacturing:
The integration of HBELs into cleaning validation strategies reflects a more science-driven approach to cross-contamination control, particularly in multi-product facilities. This encourages risk-based limits grounded in toxicological assessment, aligning with global expectations for product segregation and safety.
Updated guidance covers the production, storage, and distribution of water used in pharmaceutical manufacturing—including Purified Water and Water for Injection (WFI). There is a shift towards harmonisation with other international pharmacopoeias, and recognition of membrane-based purification technologies as an alternative to traditional distillation methods.
A new section addresses heating, ventilation and air conditioning (HVAC) systems in cleanrooms. Proper design and maintenance of HVAC systems are critical in maintaining cleanroom classification, controlling airborne particulates, and preventing microbiological contamination—particularly in aseptic processing environments.
Why This Matters
For regulatory authorities, quality assurance professionals, and pharmaceutical manufacturers, the WHO’s 10th edition compendium serves as a practical, globally relevant reference. Its guidance is intended to be adaptable across a wide range of regulatory environments, supporting harmonisation while recognising the varying capabilities of different countries and manufacturers.
With increasing scrutiny on GMP compliance and supply chain integrity—particularly in light of recent medicine shortages and quality failures—this publication arrives at a critical time.
📘 Follow this link to access the full WHO compendium here:
WHO Quality Assurance of Pharmaceuticals – 10th Edition, Volume 1