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WHO: New Edition of the GMP Compendium for Medical Products

WHO: New 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".

It consolidates essential recommendations and guidelines related to good manufacturing practices (GMP) and inspections into one publication, supporting countries in establishing robust regulatory systems and upholding international standards to combat substandard and falsified medicines.

Revised/updated WHO guidelines

  • GMPs: water for pharmaceutical use
  • GMPs for radiopharmaceutical products
  • GMPs for investigational products
  • GMPs for sterile pharmaceutical products
  • GMPs: guidelines on validation

The GMP for sterile pharmaceutical products is a harmonized text developed in collaboration with the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/s), the European Commission and the European Medicines Agency (EMA) (Annex1 to the EU GMP Guide).

Updated GMP related guidelines

  • Quality management system requirements for national inspectorates
  • Good storage and distribution practices for medical products
  • Data integrity
  • Technology transfer in pharmaceutical manufacturing
  • WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce

New WHO guidelines

  • Interpretation guideline to facilitate the implementation of the HVAC guidelines.
    This new guideline has non-binding examples, drawings, technical representations and interpretations of the HVAC systems guidelines. It is intended to be a basic and explanatory guide for use by pharmaceutical manufacturers and GMP inspectors.
  • Points to consider when including Health-Based Exposure Limits (HBELS) in cleaning validation
    It supplements the validation guidelines, specifically cleaning validation.
  • Guidance on the production of water for injection by means other than distillation
  • GMPs for medicinal gases
    Arising from an increased demand for medicinal gases, in particular the use of oxygen in the treatment of patients with coronavirus disease 2019 (COVID-19), the GMP for medicinal gases addresses requirements for the production, control, storage and distribution of medicinal gases. This document does not cover the manufacture of medicinal gases in hospitals or at home for personal use. However, the principles contained in this document may be applied in those instances to ensure that oxygen generated at hospitals or homes is suitable for the intended use and meets the quality standards.
  • GMPs for investigational radiopharmaceutical products
    GMP for investigational radiopharmaceuticals addresses current expectations and trends in GMP specific to investigational radiopharmaceuticals used in clinical trials (that is, phase I, phase II and phase III trials) and to harmonize the text with the principles from other related international guidelines.
  • Guideline on good chromatography practices highlights good practices to be considered in the analysis of samples when chromatographic methods and systems are used. The principles should be applied in the analysis of, for example, raw materials, starting materials, intermediates, in-process materials and finished products.

New GMP related guidelines

  • Points to consider for manufacturersmand inspectors: environmental aspects of manufacturing for the prevention of antimicrobial resistance
    The document outlines key considerations for both manufacturers and inspectors focused on mitigating antimicrobial resistance through better waste management in pharmaceutical facilities. It aims to educate stakeholders, including manufacturers and regulatory authorities, on relevant waste management aspects of GMP.
  • GMPs for research and development facilities of pharmaceutical products
    These GMPs address the production and control of preclinical and not-for-human-use batches manufactured in pharmaceutical formulation and development facilities, where these are directly supporting, for example, shelf-life claims, animal studies or validation activities.