Medical Device & Diagnostic Industry Magazine | MDDI Article Index
An MD&DI February 1997
Feature Article
QUALITY
FDA Makes Quality
the Rule
W. Fred Hooten
Part 2: For better or worse, the flexibility of FDA's new quality system regulation leaves industry with a lot of room to maneuver.
In the first installment of this article (MD&DI, January 1997, pp. 114-128), GMP expert W. Fred Hooten outlined some of the major changes that have made FDA's former GMP regulation into a world-class quality system regulation. The new regulation includes not only new requirements for quality management, but also new requirements for design controls--the most important change to be incorporated into the regulation. In this installment, Hooten picks up the discussion with the new regulation's requirements for document controls.--ed.
Article Contents
- Introduction
- Document Controls
- Purchasing Controls
- Identification and Traceability
- Production and Process Controls
- Acceptance Activities
- Nonconforming Product
- Corrective and Preventive Action
- Labeling and Packaging
- Handling, Storage, Distribution, and Installation
- Records
- Servicing
- Conclusion
- References
