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WHO: WHO drafts the update of GMPs for investigational products

2020/11/25  WHO

In view of an old publication date, and the recent need for new guidelines arising from inspections carried out for COVID-19 therapeutics, the World Health Organization (WHO) Prequalification Team - Inspection Services (PQT INS) raised the urgency for a revision of the WHO Good manufacturing practices for investigational pharmaceutical products for clinical trials in humans (1). 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 manufacturing practices and to harmonize the text with the principles from other related international guidelines.

Investigational products are used for testing purposes; as a reference in a clinical trial; for an unauthorized indication; and to gain further information about the authorized form.

In some cases, marketed products which have been re-packaged or modified in some way, are 101 used for investigational purposes.

The legal status of investigational products for human and veterinary use varies from 104 country to country.

These products are sometimes not covered by legal and regulatory provisions in the areas of good practices (GxP) and inspection. These complexities, such as lack of high level good anufacturing practices (GMP) requirements, risk of contamination and cross contamination, clinical trial designs, blinding and randomization, increase the risk. In addition, there are also instances where there is incomplete knowledge of the potency and toxicity of the investigational product.

There are further risks associated with the production, validation, control, shipping, storage and use of investigational products.

To minimize risks and to ensure that the results of clinical trials are unaffected by inadequate safety, quality or efficacy arising from unsatisfactory manufacture, investigational products should be manufactured and managed in accordance with an effective quality management system and the recommendations contained in this guideline.

Other guidelines and GxP should be taken into account, where relevant and as appropriate, as 122 to the stages of development, production and control of the product.

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