Derogations for Equipment Qualification 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 equipment qualification (question 6.2) were added under the heading "GMP Flexibilites".

In the case of a new production line or re-purposed facilities necessary for the supply of essential medicinal products for the treatment of COVID-19 patients, the question arises:

Is it possible to introduce premises and/or equipment with limited prospective qualification?

The answer is yes, if the extension of production is deemed necessary to ensure the availability of these crucial medicinal products. However, (only) under certain conditions:

• Application of a formal Quality Risk Management, which defines the scope and extent of the limited prospective qualification, on the way to the next level of qualification/validation.
• If necessary, additional risk mitigation measures are introduced to ensure acceptable ongoing performance and product quality.   
• All decisions are documented in the Pharmaceutical Quality System and approved by authorised personnel, including the Qualified Person.
• Regular qualification tasks will be resumed as soon as the COVID-19 restrictions are lifted.   
• An evaluation of the results of the limited prospective qualification together with the experience of the use of the premises/equipment against the expectations of a routine qualification. A programme should be in place to "take care" of identified gaps. 

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