Quality control and regulatory affairs for biopharmaceuticals (Record no. 63258)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 02026 a2200241 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 251031b |||||||| |||| 00| 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9789356516984 |
| 082 ## - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 615.7 SIN |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Singh, Anupam |
| 245 ## - TITLE STATEMENT | |
| Title | Quality control and regulatory affairs for biopharmaceuticals |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) | |
| Place of publication, distribution, etc | New Delhi: |
| Name of publisher, distributor, etc | Narendra Publishing House, |
| Date of publication, distribution, etc | 2024. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | xii, 176p.: |
| Other physical details | hbk.: |
| Dimensions | 24 cm. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc | 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<br/><br/>https://www.nphindia.com/book/9789356516984/quality-control-and-regulatory-affairs-for-biopharmaceuticals |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Quality Assurance |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmaceutical Quality Systems |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Quality Control Laboratory |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Product Quality Review |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Statistical Quality Control |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | CPCSEA Guidelines |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Post-Marketing Surveillance |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Rai, Ashish Kumar |
| Relator term | Co author |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Item type | Books |
| Source of classification or shelving scheme | Dewey Decimal Classification |
| Withdrawn status | Lost status | Source of classification or shelving scheme | Damaged status | Not for loan | Collection code | Home library | Current library | Date acquired | Source of acquisition | Cost, normal purchase price | Total Checkouts | Full call number | Barcode | Date last seen | Copy number | Cost, replacement price | Koha item type |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dewey Decimal Classification | General | IIT Gandhinagar | IIT Gandhinagar | 30/10/2025 | CBS Publishers | 2495.00 | 615.7 SIN | 036364 | 30/10/2025 | 1 | 2495.00 | Books |
