Quality Rules in Sterile Products

Revised American Edition (5-pack)

Häftad, Engelska, 2002

1 152 kr

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Beskrivning

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.

Produktinformation

Utgivningsdatum:2002-06-30
Mått:138 x 216 x undefined mm
Vikt:109 g
Format:Häftad
Språk:Engelska
Antal sidor:70
Förlag:Taylor & Francis Inc
ISBN:9781574911343

Utforska kategorier

Farmakologi inom Medicin

Mer om författaren

Associated with the pharmaceutical industry for more than forty years, John Sharp has held senior management positions in Quality Assurance, Production, Materials, Management, and Distribution. As Principal Inspector with the British Medicines Inspectorate, he edited and produced the UK “Orange Guide” to GMP, which later formed the basis of the EC’s GMP guidelines. He now operates his own consultancy, specializing in GMP training. He is the author of numerous QA and GMP books, including the original best-selling Quality Rules series.

Innehållsförteckning

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.