Medical Device & Diagnostic Industry
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An MD&DI February 1997
Feature Article

QUALITY

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.

1. 
   Introduction
   
2. Document Controls
3. Purchasing Controls
4. Identification and Traceability
   
5. 
   Production and Process Controls
   
6. 
   Acceptance Activities
   
7. 
   Nonconforming Product
   
8. 
   Corrective and Preventive Action
   
9. 
   Labeling and Packaging
   
10. 
    Handling, Storage, Distribution, and Installation
11. 
    Records
12. 
    Servicing

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