Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach

5-page question and answer (Q&A) white paper addresses FDA's initiatives for 21st Century CGMPs and the modernization of pharmaceutical quality systems. While the FDA encourages modernization and harmonizing with other quality system requirements, the agency is also required to ensure manufacturers comply with CGMPs (21 CFR Parts 210, 211) and electronic system requirements (21 CFR Part 11).


Downloads:

Q&A:
Pharmaceutical CGMP for 21 st Century

Q&A:
FDA's Quality Systems Approach to Pharmaceutical CGMPs

Q&A:
CDER Offical Offers Tips on GMP Inspections

White Paper:
Change Control - Quality Improvements in FDA and ISO Environments

White Paper:
Does Your CAPA System Need a CAPA?

White Paper:
Automating Document Control Processes to Comply with FDA and ISO Requirements

White Paper:
Automating Training Processes to Comply with FDA and ISO Requirements
White Paper:
21 CFR Part 11 - Risk of Non-compliance

 




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