News about GMP/cGMP


WHO: First draft guideline on GMP for research and development facilities

In November 2020, the WHO published a first draft on GMP for research and development facilities.

The 33-page working document "Good practices for research and development facilities", like the recently published draft on GMP for investigational medicinal products (we reported), was driven by the need for more stringent regulation in this field. A major reason is the rapid development of Covid-19 therapeutics. In addition, the authorities also require and review information such as development data of products or processes, design of experiments or validation and stability results. This leads to the need for good practice also in this field. 

The future guideline should regulate the following:  

  • Manufacturing of development batches  
  • Pilot Batches 
  • Sequential stability data submitted in product applications for authorization (dossiers) 
  • Prequalification of medical products 

Further fields to be regulated by the guideline are  

  • Development of processes and procedures for transfer and use in marketing authorization applications  
  • (Process) validation  
  • Technology Transfer  
  • Quality control laboratory activities such as stability testing and development and validation of cleaning procedures.   

All these steps should be risk-based and based on a GMP-compliant quality system.  

The guideline is applicable to products manufactured by  

  • Chemical synthesis  
  • Extraction  
  • Cell culture or fermentation  
  • Recovery from natural sources  
  • Combination of these processes 

The working document also contains a list of documents that are also relevant in this context. It can be commented on until 6 January 2021 and will be presented at the 56th meeting of the ECSPP in October 2021.   


WHO: Good practices for research and development facilities