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Guidance’s on GMP for Investigational Products & for R&D facilities -WHO

World Health Organization (WHO) recently issued revised guidance to industry addressing good manufacturing practices (GMPs) for investigational drug products and a new draft guideline addressing GMP principles for research and development facilities.

GMPs for Investigational Drug Products

The objective of the update to good manufacturing practices (GMPs) for investigational drug products guidance 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 and this guideline is applicable only to investigational products for human use.

To minimize risk; to ensure the safety of the subjects participating in clinical trials; 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.

Good Practices for Research and Development Facilities of pharmaceutical products

There is currently no other specific WHO guideline that addresses this matter. The data collected from these batches influence the following aspects of the product:

  • Stability

  • Process validation

  • Analytical method development and validation.

This document intends to provide guidance on good manufacturing practices (GMP) to research and development facilities. It further aims to ensure that the correct systems are followed, ensuring appropriateness, reliability, and the quality of products, processes, procedures, and data. This further helps to help ensure that products meet the requirements for safety, efficacy, and quality that they purport to possess.

These both guidance’s are draft working documents for comments which will close by 31-August-2021.


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