We have seen instances where the ultimate “no confidence” vote is cast when third-party experts are either recommended by FDA, or court ordered to take over their duties. (See The QA Pharm 9/25/10.)
a. Establish the quality management system to describe how the firm complies
CGMPs and operates to maintain a state of control
a. Audit for compliance to policies and procedures: on paper vs. practice
decision making for targeted actions
How does your Quality Unit compare?
John Snyder & Company, Inc.
Also, find me on LinkedIn for peer-reviewed articles on Quality Management System Topics.
- Federal Register Vol. 43, No 190 – Friday, September 29, 1978, “Preamble to the Drug CGMPs”
- The Code of Federal Regulations Part 210 and 211
- Guidance for Industry, Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (September 2006)
- ICH Q10 Pharmaceutical Quality System (June 2008)