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:
Further fields to be regulated by the guideline are
All these steps should be risk-based and based on a GMP-compliant quality system.
The guideline is applicable to products manufactured by
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.