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· 제목 : Manufacturing of Quality Oral Drug Products : Processing and Safe Handling of Active Pharmaceutical Ingredients (API) (Hardcover)
· 분류 : 외국도서 > 경제경영 > 보험 > 위험요소 평가/관리
· ISBN : 9781032124735
· 쪽수 : 208쪽
· 출판일 : 2022-06-27
· 분류 : 외국도서 > 경제경영 > 보험 > 위험요소 평가/관리
· ISBN : 9781032124735
· 쪽수 : 208쪽
· 출판일 : 2022-06-27
목차
1. Milling & Charging 2 Chapter 2 - Granulation 3. Compression 4. Sub-Coating 5. Membrane Coating 6. Drilling 7. Drying 8. Overcoating 9. Printing 10. Sorting & Packing 11. Capsule filling 12. Safe Handling of API & Drugs 13. Data Integrity Compliance 14. Guidelines for Statistical Procedure 15. Calibration 16. Clean-In-Place 17. Cleaning Validation 18. Manufacturing Process Validation 19. Risk Based Life Cycle Management 20. pFMEA Manufacturing Procedure 21. Analytical Methods Development, Validation, and Transfer Appendices
