News about GMP/cGMP


WHO: New draft on GMP for investigational products

The WHO published a draft on GMP for investigational products in November 2020. The 28-page working document comprises 18 chapters and can be commented on until 6 January 2021. The guideline currently in force and consisting of 12 pages was published in 1996.  

Considering the old publication date, the responsible team of the WHO called for a revision of the guideline WHO Good manufacturing practices for investigational pharmaceutical products for clinical trials in humans (1). In addition, the need for new guidelines arose from the inspections that are currently being carried out with the development of Covid-19 therapeutics.   

The update is intended to bring the guideline in line with current expectations and trends in GMP and to harmonize it with similar international guidelines. The document should be read in conjunction with other WHO GxP guidelines, which include Good Clinical Practice (GCP).  

The recommendations of the draft guideline are applicable to human and veterinary medicinal products. In some cases they may also be applied to other, non-pharmaceutical investigational products.   

According to the draft, investigational products should be manufactured in a way that  

  • is GxP compliant and includes an effective QRM system,  
  • protects participants in clinical trials from products of poor quality due to unsatisfactory manufacturing,  
  • ensures conformity between and within batches of an investigational product  
  • and ensures consistency between the batches of the investigational product and the future commercial product.  

The final document is expected to be presented at the 56th meeting of the ECSPP in October 2021.  

WHO: Good manufacturing practices for investigational products