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?
The QA Pharm is a service of John Snyder & Company, Inc.
John Snyder & Company, Inc., provides consulting services to companies regulated by the Food and Drug Administration. We help our clients to build an effective Quality Management System to enable reliable supply of quality products to their patients. We also help our clients to develop corrective action plans to address regulatory compliance observations and communication strategies to protect against accelerated enforcement action.
Contact us at email@example.com.
- 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)