WHO Issues Draft GMP Guidelines for Investigational Therapeutics
The COVID-19 pandemic has spurred the World Health Organization (WHO) to release new draft guidelines on good manufacturing practices (GMPs) for investigational therapeutics.
Drugs used in clinical trials should be made to be compliant with GMPs “as appropriate to the stage of development,” the WHO explains.
Sponsors should use GMPs to ensure that clinical trial subjects are protected from poor quality products due to unsatisfactory manufacturing, to assure consistency between and within batches, and to allow data gathered from the clinical trial to be usefully compared with that gathered from the future marketed product, the new draft guideline says.
The quality management system should, among other things, ensure compliance with good laboratory practice, good clinical practice, and good storage and distribution practices, the WHO says.