| Pharmaceutical Quality Systems Contributor(s): Schmidt, Oliver (Editor) |
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ISBN: 0367398702 ISBN-13: 9780367398705 Publisher: CRC Press OUR PRICE: $78.84 Product Type: Paperback - Other Formats Published: September 2019 |
| Additional Information |
| BISAC Categories: - Medical | Pharmacy - Medical | Pharmacology - Science | Chemistry - General |
| Dewey: 615.190 |
| Physical Information: 0.9" H x 6" W x 8.9" (1.20 lbs) 392 pages |
| Descriptions, Reviews, Etc. |
| Publisher Description: When a pharmaceutical company decides to build a Quality System, it has to face the fact that there aren't any guideline that define exactly how such a system has to be built. With terms such as quality system, quality assurance, and quality management used interchangeably, even defining the system's objectives is a problem. This book provides a practical guide to building a quality system. Beginning with explanations of key terms and concepts, it covers ISO 9000 and GMP and how to combine them, and includes a matrix showing their similarities and differences. Implementation reviews illustrate how Quality (Management) Systems have been installed successfully in pharmaceutical companies. Also covered are the individual components of a Quality System; auditing, validation, and supplier qualification systems; and Hazard Analysis Critical Control Points (HACCP). |