GAMP CoP UK Forum

The next GAMP CoP UK Forum will be held on 25-Apr-2023. Topics will include Computer Software Assurance (CSA), Blockchain Validation, Lab Equipment Qualification, Cell & Gene Therapy, and applying ISPE GAMP 5 2nd Edition. Register to attend via the ISPE website.

EU GMP Annex 11 Concept Paper

The European Medicines Agency (EMA) has published a concept paper on the revision of Annex 11 of the guidelines on Good Manufacturing Practice (GMP) for medicinal products - Computer Systems. The proposed guidelines will replace Eudralex Volume 4: Annex 11 Computerised Systems.

FDA CSA Guidance Published

The FDA has published their draft guidance for Industry, "Computer Software Assurance for Production and Quality System Software". This guidance provides recommendations on CSA for computers and automated data processing systems used as part of medical device production or the quality system. Copies of the guidance are available on the FDA website.