Pharmaceutical master validation plan : the ultimate guide to FDA, GMP, and GLP compliance / Syed Imtiaz Haider.
By: Haider, Syed Imtiaz
Material type: 
TextLanguage: English Publisher: Boca Raton : St. Lucie Press, c2002Description: xxxi, 176 p. : ill. ; 25 cm. +ISBN: 1574443305 (alk. paper); 9781574443301Subject(s): Pharmaceutical technology -- Quality control | Pharmaceutical industry -- Quality control | Drug Industry -- standardsDDC classification: 615.19021873 LOC classification: RS192 | .H3533 2002Online resources: WorldCat details | Ebook Fulltext | Item type | Current location | Collection | Call number | Copy number | Status | Date due | Barcode | Item holds |
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EWU Library Audio Visual | Non-fiction | 615.19021873 HAP 2002 (Browse shelf) | C-4 | Available | CD-1156 | ||
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Includes bibliographical references and index.
Table of contents Validation master plan approval page --
1. Introduction --
2. Concept of qualification/validation --
3. Revalidation --
4. Facility description --
5. Description of building --
6. Equipment description --
7. HVAC description --
8. Utilities descriptions --
9. Validation program overview --
10. Calibration program summary --
11. Preventive maintenance program summary --
12. Key standard operating procedures (SOPs) --
13. Validation of building --
14. Validation of utility systems --
15. Process description for dry production facility: Building A --
16. Process description for liquid and semisolid production facility: Building B --
17. Process description for parenterals production facility: Building C --
18. Qualification of process equipment --
19. Validation of support processes --
20. Quality assurance/control laboratory validation --
21. cGMP procedures and programs --
22. Validation schedule --
23. Drawings for ABC pharmaceutical plant.
Summary:
This text provides the tools to minimize non-conformance, reduce rework and rejected lots, avoid recall lots, and more easily achieve new drug approval, satisfactory inspections, corporate legal Read more...
Pharmacy
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