Derogation for Process Validation due to Covid-19

Recommendation

4/5 October 2023

Advanced Level: Trending of Process Data for OPV/CPV - Live Online Training

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:

• The use of a concurrent validation approach, as listed in Annex 15, should be documented in the Pharmaceutical Quality System and approved by authorised personnel, including the Qualified Person.
• When using a concurrent validation approach, sufficient data should be available to help decide that each batch is uniform and meets the acceptance criteria.
• All equipment and test methods associated with the concurrent validation should be appropriately qualified and validated before the application of a concurrent validation.
• In the manufacture of sterile medicinal products, the process that ensures sterility must be prospectively validated. This includes sterilization processes for terminally sterilized products, sterilization of equipment for an aseptic process and media fills.   
• The manufacturing process and quality control requirements must comply with the specifications of the marketing authorisation. Changes must be made using the variation procedure according to EC Regulation 1234/2008. However, with reference to the questions and answers in numbers 2.1 and 3.1, there are exceptions in the form of an exceptional change management process. 

More information can also be found under QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC.