16/17 November 2021
Europe is taking exceptional steps to ensure that the population continues to receive high quality, effective and safe medicinal products during the Covid-19 pandemic. A Questions & Answers document has been prepared in cooperation between the European Commission, the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh), the "Inspectors Working Group" and the European Medicines Agency (EMA) - please also see "COVID-19: Update of the Q&A document - Validity of GDP Certificates and Wholesale Authorisations". At the end of May, special features for process validation (question 6.2) were added under the heading "GMP Flexibilites".
In the case of a new production line or redesigned facilities necessary for the supply of essential medicinal products for the treatment of COVID-19 patients, the question arises:
Is a concurrent validation of the manufacturing process possible?
The answer is yes, for crucial medicinal products to treat Covid-19 patients for whom a supply shortage could affect their treatment. In this case, a concurrent validation is more feasible than a prospective validation. However, there are certain framework conditions:
More information can also be found under QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC.