WHO: Draft on Good Practices for Pharmaceutical Quality Control Laboratories

The WHO has recently published a draft document that will be of interest to all GMP practitioners in the field of pharmaceutical quality control laboratories: WHO good practices for pharmaceutical quality control laboratories. It provides recommendations for a Quality Management System (QMS) within which analyses of pharmaceutical products should be performed by quality control laboratories. The aim is to ensure accurate and reliable analytical results.

History:

First published in 2002, the document was renamed "WHO good practices for pharmaceutical quality control laboratories" in 2010 and published as a revised version. In 2022, above all the findings from the COVID pandemic have revealed how important topics such as risk and crisis management are, but also the guaranteed continuity of operational processes in times of crises. Furthermore, experiences from inspection results have shown that a renewed revision of the guideline is indicated.

The new topics in brief:

New definitions such as data integrity, crisis management, uncertainties due to deviations in measurements and risks, e.g., due to pandemics or environmental disasters, also point the way to new content on data control, quality risk management, and strategies for well-planned crisis management. Also newly covered are the handling and estimation of measurement uncertainties from a specific source of deviation, an "expanded uncertainty", such as the maximum permissible deviation from the nominal volume for volumetric instruments.

The document does not include recommendations for laboratories testing biological products, such as vaccines, blood products, or microbiology laboratories. The 83-page document is open for comments until 6 October 2023.

Source:

WHO: WHO good practices for pharmaceutical quality control laboratories