The customers of many disposable medical device manufacturers require that their vendors adhere to a quality management system that is demonstrably planned and complete.
To do so, manufacturers often find they must:
- Complete quality assurance functions and inspections for critical characteristics on their disposable medical devices
- Detail, in chronological order, all phases of their production processes
- Provide proof of cGMP compliance (Current Good Manufacturing Practices) for FDA products, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
Our article entitled “What is a Control Plan or FDA Performance Qualification (PQ)” strives to help you understand the methods and control points the FDA and/or customer auditors will be looking for. An actual Control Plan/ Performance Qualification is included for your review. Please click here to read the article.