WHO issues draft guidelines on GMP for investigational products and GP for R&D facilities

The World Health Organisation (WHO) has recently issued draft guidelines for comment, on Good Manufacturing Practices (GMP) for investigational products and Good Practices for research and development facilities of pharmaceutical products.

WHO good manufacturing practices for investigational products (updated guideline)

In view of an old publication date, and the recent need for new guidelines arising from inspections carried out for COVID-19 therapeutics, the WHO Prequalification Team – Inspection Services raised the urgency for a revision of the WHO Good manufacturing practices for investigational pharmaceutical products for clinical trials in humans . The Fifty-fifth Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) concurred with this proposal.

The objective of this update is to bring the guideline in line with current expectations and trends in good practices and to harmonize the text with the principles from other related international guidelines.

You can view the draft here.

WHO good practices for research and development facilities of pharmaceutical products (new guideline)

In view of the need for the development of health products, including the research and development for the treatment of COVID-19 therapies, the WHO Prequalification Inspection Services Team raised the urgency for the development of life cycle appropriate good practices text to address the manufacturing of developmental batches, pilot batches and the sequential stability data that are submitted in product applications (dossiers) for marketing authorisation and the prequalification of medical products.

There is currently no other specific WHO guideline which addresses this matter.

You can view the draft here.

Deadline for comments

Comments should be sentto Dr Steve Estevão Cordeiro, Technical Officer, Norms and Standards for Pharmaceuticals, Technical Standards and Specifications (estevaos@who.int), with a copy to Ms Sinéad Jones (jonessi@who.int) before 31 August 2021. Please use the “Table of Comments” document (available here) for this purpose.