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QA Manual
This is a comprehensive and detailed guide to management of Quality Assurance in pharmaceutical production facilities. It includes Facility Design
Equipment
Production Controls
Bulk Pharmaceutical Chemicals
Laboratory Controls
Personnel
Validation
Documentation
Audits A manufacturer must, in designing, making and marketing a medicine, satisfy the regulatory authorities and himself that his products are of adequate quality, safety and efficacy. Application of the principles of quality assurance and of good manufacturing surveillance, all contribute to the assurance of quality. The purpose of this book therefore is to provide an instant knowledge-base of such systems and procedures which will help a pharmaceutical manufacturer to comply with most countries legislation's with regard to quality assurance and cGMP requirements.
Equipment
Production Controls
Bulk Pharmaceutical Chemicals
Laboratory Controls
Personnel
Validation
Documentation
Audits A manufacturer must, in designing, making and marketing a medicine, satisfy the regulatory authorities and himself that his products are of adequate quality, safety and efficacy. Application of the principles of quality assurance and of good manufacturing surveillance, all contribute to the assurance of quality. The purpose of this book therefore is to provide an instant knowledge-base of such systems and procedures which will help a pharmaceutical manufacturer to comply with most countries legislation's with regard to quality assurance and cGMP requirements.
312 pages, Hardcover
First published May 1, 2002
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