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... Read more
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
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
Biography
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.
