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This resource provides a guide to the regulations and standards which govern the international pharmaceutical industry. Featuring explanations of regulations and strategies to maintain compliance, the book covers the key principles of best-practice for laboratory research, manufacturing and distribution.
Table des matières
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
A propos de l'auteur
Navneet Sharma, PhD, is an Assistant Professor at Amity Institute of Pharmacy, Amity University, India.
Vikesh Kumar Shukla, PhD, is an Associate Professor and Centre Head at Amity Institute of Pharmacy, Amity University, India.
Sandeep Arora, PhD, is a professor and director at the Amity Institute of Pharmacy, Amity University, India.
Résumé
This resource provides a guide to the regulations and standards which govern the international pharmaceutical industry. Featuring explanations of regulations and strategies to maintain compliance, the book covers the key principles of best-practice for laboratory research, manufacturing and distribution.
