PHARMACEUTICAL QUALITY ASSURANCE (For all Pharmacy Students)

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Authors Name V.V. Konduskar
ISBN 13 9789354518416
Publisher Nirali Prakashan
Edition First
Pages 197
Language English
Publishing Year Jan-23

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Description

1. Introduction of Quality Assurance
2. Current Good Manufacturing Practices
3. Standard Operating Procedure (SOP)
4. Introduction of Validation
5. Process Validation
6. Validation Master Plan
7. Cleaning Validation
8. Computerized System Validation
9. Compressed Air Validation
10. Analytical Method Validation
11. Heating Vantilation and Air Conditioning (HVAC)
12. Water System
13. Hold Time Study
14. Elemental Impurities
15. Qualification
16. Vendor Qualification
17. Risk Assessment
18. Change Control
19. Deviation
20. Corrective Action and Preventive Action
21. Recall
22. Site Master File (SMF)
23. Drug Master File (DMF)
24. Market Complaint
25. Annual Product Quality Review (APQR)
26. Out of Specifications (OOS)/Out of Trend (OOT)
27. Batch Manufacturing Record
28. Batch Packing Record
29. In-Process Quality Control
30. Pharmaceutical Guidelines
Abbreviations
References

Additional information
Weight 260 g
Dimensions 24 × 18 × 1 cm
Language

English

Publisher

University

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    PHARMACEUTICAL QUALITY ASSURANCE (For all Pharmacy Students)