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Risk Assessment, FDA DRUG GMP

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John Lee, Video 7 of 9

This 7th video (out of 9 in total) focuses on Risk Assessment.
FDA Drug GMP is not as explicit and direct in the legislation on Risk Assessment as compared to EU Drug GMP legislation, e.g.:

"As part of a quality risk management system, decisions on the scope and extent of qualification and validation should be based on a justified and documented risk assessment of the facilities, equipment, utilities and processes" (EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines, Annex 15, Qualification and Validation (since 2015)).

FDA expectations on properly applying Risk Assessment are however seen in the FDA enforcement (and relevant guidelines, e.g. ICH Q9) when reviewing Warning Letters and 483’s. As pinpointed by John Lee, Risk Assessment is not whether or not to qualify a piece of equipment or validate a process. Risk Assessment is to assess the required scope and extent of the qualification or validation.

The video is recorded during the COVID-19 US lock-down by John Lee with mobile recording equipment, and the quality could be better. Focus on the great presentation and content instead.

Relevant sources:

1) ASTM E2500-13, Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment (
2) Eudralex Vol 4, Annex 1, draft 2, Manufacture of Sterile Medicinal Products (
3) FDA GFI: Process Validation: General Principles and Practices (Jan. 2011) (
4) FDA/ICH, (CDER and CBER), Q9 Quality Risk Management, guidance for industry, June 2006 (

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