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Trends. FDA Drug GMP versus EU Grug GMP

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John Lee, Video 5 of 9

This 5th video (out of 9 in total) focuses on trends as seen in the FDA Enforcement for the period 2019-2020, however reviewing this as compared to earlier year.

In the introductory section (before the John Lee video), for once there is a comparison between FDA Drug GMP and EU Drug GMP respectively trying to identify similarities and/or differences in the citations and deficiencies. EU Drug GMP has not been included in the earlier 4 released videos.

The review documents that Validation is a repeated issue (e.g. Process Validation and Supplier Validation). Again, Validation is the overall deficiency causing a Warning Letter. For comparison, Validation is also the most frequent citation in the European Non-Compliance Reports (NCR). This has been the case, actually since 2012 (US) / 2014 (Europe). Industry needs to improve.

Reference to Validation is seen in,

FDA, cGMPs for Finished Pharmaceuticals (reference to validation)
211.68 Computer and automation validation
211.84 Reliability of supplier’s test results
211.94 Depyrogenation
211.110 Manufacturing Process
211.113 Sterilization Process
211.165 Analytical Methods

EudraLex - Volume 4 – GMP guidelines, reference to validation
Annex 11: Computerized systems
Annex 15: Qualification and validation

Check the new draft to Annex 1, Manufacture of Sterile Products, incl. reference to ICH Q9, Quality Risk Management.


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CEO & seniorkonsulent
IT & Automation / GAMP, Regulatory Affairs, Project Management, Management Consulting, GMP, Træning

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