Pharmaceutical master validation plan : the ultimate guide to FDA, GMP, and GLP compliance /: the ultimate guide to FDA, GMP, and GLP compliance. (©2002)

• Record Type: Book
• Further Information: Note: Syed Imtiaz Haider.
• Other Names: Haider, Syed Imtiaz
• Contents: 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.
• Publisher Details: Boca Raton : St. Lucie Press
• Publication Date: 2002
• Copyright Date: 2002
• Extent: 1 online resource (xxxi, 176 pages), illustrations
• Subjects: 615/.19/021873; Pharmaceutical technology -- Quality control; Pharmaceutical industry -- Quality control; Drug Industry -- standards; Drug and Narcotic Control; Facility Regulation and Control; Guideline Adherence -- organization & administration; Quality Control; Technology, Pharmaceutical -- standards; MEDICAL -- Drug Guides; MEDICAL -- Pharmacology; MEDICAL -- Pharmacy; MEDICAL -- Nursing -- Pharmacology; Pharmaceutical industry -- Quality control; Pharmaceutical technology -- Quality control; Electronic books
• Languages: English
• ISBNs: 1420025392; 9781420025392
• Related ISBNs: 1574443305
• Notes: Note: Includes bibliographical references (pages 169-170) and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.