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· 분류 : 외국도서 > 의학 > 약리학
· ISBN : 9781032817040
· 쪽수 : 306쪽
· 출판일 : 2025-06-24
목차
1. US Pharma Manufacturing Standards: Cfr 210 & 211
2. A Comprehensive Review on the Good Manufacturing Practices Standards: Directive 91/356 of the European Commission
3. Integration Of Cgmp & Gamp-5 In Pharmaceutical Manufacturing
4. Medical Device and Ivds Global Harmonization Task Force Guidance Documents
5. Current Scenario and Future Perspective of Good Laboratory Practices
6. Advancing Laboratory Excellence: A Comprehensive Review of Quality Audits
7. Introduction of Good Automated Laboratory Practices (Galp): Principles and Comparative Analysis Across Regulatory Authorities - Usfda, Ema, Cdsco, And Tga
8. A Framework to Understanding E-Records Under 21cfr Part 11
9. Current Trends in Good Distribution Practices (Gdp)
10. Navigating The Pharmaceutical Supply Chain: Ensuring Integrity Amidst Challenges
11. Optimizing Pharmaceutical Quality: Exploring Out of Specification, Total Quality Management, Change Control
12. Insights Into the Six Sigma Concept
13. Good Regulatory Practices and Validation Plans in Pharmaceutical Practices
14. Critical Utility Validation: An Innovative Approach to Pharmaceutical Best Practices
15. International Council of Harmonization: Reception to Implementation
16. ISO-13485 and Schedule MIII ? Quality Management System














