Pharmaceutical process validation / edited by Robert A. Nash, Alfred H. Wachter.
Material type:
TextSeries: Publication details: New York : Marcel Dekker, c2003. Edition: International 3rd ed., rev. and expandedDescription: xxxvi, 860 p. : ill. ; 24 cmISBN: 0824708385 ; 9780824708382Subject(s): Pharmaceutical industry | Drugs | Drug Evaluation | Drug Industry | Quality ControlDDC classification: 615.10685 PHA Online resources: Click here to access online
| Item type | Current library | Home library | Call number | Status | Date due | Barcode | Item holds |
|---|---|---|---|---|---|---|---|
English Lending
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Villa College QI Campus | Villa College Library | 615.10685 PHA (Browse shelf(Opens below)) | Available | 14476 |
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| 615.1024613 GRE Trounce's clinical pharmacology for nurses / | 615.1024613 GRE Trounce's clinical pharmacology for nurses / | 615.1024613 GRE Trounce's clinical pharmacology for nurses / | 615.10685 PHA Pharmaceutical process validation / | 615.11083 BNF BNF 75 : March - Setember 2018 / | 615.11083 BNF BNF 75 : March - Setember 2018 / | 615.11083 BNF BNF 75 : March - Setember 2018 / |
CONTENT
1. Regulatory Basis for Process Validation
2. Prospective Process Validation
3. Retrospective Process Validation
4. Sterilization Validation
5. Validation of Solid Dosage Forms
6. Validation of Medical Devices
7. Validation of Biotechnology Processes
8. Transdermal Process Validation
9. Validation of Lyophilized Products
10. Validation of Inhalation of Aerosols
11. Process Validation of Pharmaceutical Ingredients
12. Qualification of Water and Air Handling Systems
13. Equipment and Facility Qualification
14. Validation and Verification of Cleaning Processes
15. Analytical Methods Validation
16. Computer Systems Validation
17. Integrated Packaging Validation
18. Analysis of Process Data Using Quality Control Charts
19. Statistical Methods for Blend Uniformity and Dissolution Testing
20. Change Control and SUPAC
21. Process Validation and Quality Assurance
22. Validation in Contract Manufacturing
23. Terminology on Non-Aseptic Process Validation
24. Harmonization, GMPs, and Validation
Includes references and index
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