Quality control and regulatory affairs for biopharmaceuticals

By:

Singh, Anupam

Contributor(s):

Rai, Ashish Kumar [Co author]

Publication details: New Delhi: Narendra Publishing House, 2024.Description: xii, 176p.: hbk.: 24 cmISBN:

9789356516984

Subject(s):

DDC classification:

615.7 SIN

Summary: Concept and Evolution of Quality Control and Quality Assurance .2. Quality Control Laboratory Responsibilities 3. CPCSEA Guidelines 4. Quality Review and Batch Release Document of Finished Products 5. Annual Product Quality Review and Parametric Release 6. Audits 7. Quality Audits of Manufacturing Processes and Facilities 8. Good Documentation Practices 9. Root Cause Analysis 10. Corrective Action Preventive Action (CAPA) 11. Out of Specifications (OOS) and Out of Trend (OOT) 12. Clinical Studies - ICH GCP (E6) guidelines 13. Post Marketing Surveillance 14. Pharmacovigilance .15. Bioavailability and Bioequivalence Studies 16. Concepts and Management of Contract Manufacturing Guidelines 17. Statistical Tools for Quality Control and Precision 18. Tools of Problem Solving and Continuous Improvement .19. Introduction to Intellectual Property Rights (IPR)20. Introduction to Intellectual Property Rights (IPR)21. Concept of Trademark, Copyright, and Patents 22. Product Registration Guidelines – CDSCO, USFDA 23. Concept of ISO (9001): (2008), (14000), OSHAS Guidelines 24. Quality Strategy for Indian Industry25. Brief Concept of IND, NDA, ANDA, SNDA, and PAT https://www.nphindia.com/book/9789356516984/quality-control-and-regulatory-affairs-for-biopharmaceuticals

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Item type	Current library	Collection	Call number	Copy number	Status	Barcode
Books	IIT Gandhinagar	General	615.7 SIN (Browse shelf(Opens below))	1	Available	036364

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Concept and Evolution of Quality Control and Quality Assurance .2. Quality Control Laboratory Responsibilities 3. CPCSEA Guidelines 4. Quality Review and Batch Release Document of Finished Products 5. Annual Product Quality Review and Parametric Release 6. Audits 7. Quality Audits of Manufacturing Processes and Facilities 8. Good Documentation Practices 9. Root Cause Analysis 10. Corrective Action Preventive Action (CAPA) 11. Out of Specifications (OOS) and Out of Trend (OOT) 12. Clinical Studies - ICH GCP (E6) guidelines 13. Post Marketing Surveillance 14. Pharmacovigilance .15. Bioavailability and Bioequivalence Studies 16. Concepts and Management of Contract Manufacturing Guidelines 17. Statistical Tools for Quality Control and Precision 18. Tools of Problem Solving and Continuous Improvement .19. Introduction to Intellectual Property Rights (IPR)20. Introduction to Intellectual Property Rights (IPR)21. Concept of Trademark, Copyright, and Patents 22. Product Registration Guidelines – CDSCO, USFDA 23. Concept of ISO (9001): (2008), (14000), OSHAS Guidelines 24. Quality Strategy for Indian Industry25. Brief Concept of IND, NDA, ANDA, SNDA, and PAT

https://www.nphindia.com/book/9789356516984/quality-control-and-regulatory-affairs-for-biopharmaceuticals

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