1st Edition

Quality Rules in Sterile Products Revised American Edition (5-pack)

By John Sharp Copyright 2002
    70 Pages
    by CRC Press

    This newly-revised and specifically American edition of the best-selling original is the perfect introduction Good Manufacturing Practice (GMP) as it relates to manufacturing sterile products. Quality Rules in Sterile Products Manufacture is the ideal training resource for workers recently hired into the pharmaceutical, chemical, biotechnology, and bulk pharmaceutical industries. The central tool for many corporations' introductory training, retraining, and reinforcement programs, it covers all the sterile products GMP concepts required by the US FDA, the British MCA, and the European GMPs. In a simple, no-nonsense manner, the author explains the rationale of GMP and the key role played by workers in the production and packaging of pure, safe, and quality sterile products.

    Quality and Sterile Products
    Types of Contamination
    Sources of Contamination
    Control of Contamination--Clean Rooms
    Control of Contamination--People
    Control of Contamination--Cleaning and Disinfection
    Control of Contamination--Water and Other Materials
    Sterilization
    Conclusion
    Appendix A: Clean Rooms