WHO: Updated Edition of the GMP Compendium for Medical Products

The World Health Organization (WHO) has published the 10th edition of the "Quality Assurance of Pharmaceuticals: a Compendium of Guidelines and Related Materials, Volume 2, Good Manufacturing Practices (GMP) and Inspection." This publication consolidates crucial recommendations and guidelines regarding GMP and inspections, aiding countries in establishing robust regulatory frameworks and meeting international standards to combat substandard and falsified medicines.

Revised and updated WHO guidelines cover various aspects, including GMPs for water, radiopharmaceutical products, investigational products, sterile pharmaceutical products, and validation. The GMP for sterile pharmaceutical products is a collaborative effort with PIC/s, the European Commission, and the European Medicines Agency.

Newly introduced guidelines encompass interpretation of HVAC systems, Health-Based Exposure Limits (HBELs) in cleaning validation, water for injection production, medicinal gases production, investigational radiopharmaceutical products, good chromatography practices, environmental considerations for antimicrobial resistance prevention, and GMPs for research and development facilities producing preclinical and not-for-human-use batches.