Launching for the first time ever, the most 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.