Abstract
Proposed large-volume parenterals (LVP’s) represent only one of many sets of complex new GMP regulations introduced in the 1970’s. Many require a variety of written procedures. Pfizer Inc., multinational producer of ethical and OTC pharmaceuticals (including component bulk chemicals), medical devices (critical and non-critical), cosmetics, food additive chemicals, medicated animal feed premixes, and other products, found most of its product line affected. Quality assurance’s DRUMBEAT system reduces all GMP’s into a simple package, permitting Pfizer to quickly match its thousands of written procedures, for example, against regulatory requirements. Versatility of the system makes it applicable to a wide variety of similar problems.
- Received November 26, 1979.
- Accepted December 26, 1979.
- Copyright © Parenteral Drug Association. All rights reserved.
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