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| Validation Standard Operating Procedures. A Step-by-Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries | Buy a book...
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| Author(s): | S. Imtiaz Haider |
| Publisher: | Taylor & Francis |
| ISBN: | 0849395291 |
| Format: | hardback + CD-ROM |
| 1118pp | |
| Price: | £155.00 |
| Review Date: | 21 August 2006 |
| Review: | As the validation master plan proceeds, the facility is integrated into the regulators guidelines of the FDA. Current good manufacturing practices (cGMPs), good laboratory practices (GLPs), and the need for comprehensive and well-defined validation supporting standard operating procedures is given in the text and on the CD-ROM. The first edition covered Val. Sections 200–1300, providing 75 validation standard operating procedures (SOPs) on design qualification, utilities qualification, equipment qualification, training needs, and major sterile and non-sterile operations-related equipment. This new edition includes Val. Sections 1400–2300, with 64 new validation SOPs added to describe the documentation that is needed for sterility assurance, qualification and requalification template reports of major sterile equipment, critical applicable procedures, templates for certification guidelines, media fill procedures, environmental control guidelines, training, and critical environmental performance evaluation procedures. |