Quality rules in active pharmaceutical ingredients manufacture
Author(s)
Bibliographic Information
Quality rules in active pharmaceutical ingredients manufacture
Interpharm/CRC, c2002
American ed
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Description and Table of Contents
Description
The fifth booklet in the best-selling Quality Rules series presents the basic concepts of quality and current Good Manufacturing Practice (cGMP) in a manner easily understood by operators involved in the manufacture and quality assurance of active pharmaceutical ingredients (APIs). Drawing on the guidelines prepared under the ICH and made available by the US FDA, this booklet covers all the cGMP concepts required as training, retraining, and reinforcement resource for workers recently hired into the API manufacturing industry. In his familiar, no-nonsense style, the author explains the rationale of cGMP and the key role played by workers in the production and packaging of pure, safe, and quality APIs.
Table of Contents
Quality and Pharmaceutical Ingredients Manufacture. Making Drug Products and APIs. CGMP and the Law--The FDA. The Paperwork--Documentation and Records. Labels. Cleanliness and Avoiding Contamination. Equipment Maintenance, Cleaning, and Calibration. Packaging. Sterile APIs. Conclusion--People and cGMP.
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