This unique resource provides a comprehensive guide to the evolving regulations and standards which govern the international pharmaceutical industry.Featuring clear explanations of the latest regulations, as well as insights and strategies to maintain compliance, the book covers the key principles of best-practice for laboratory research, manufacturing and distribution. It also offers strategies to navigate the intricacies of different regulatory environments so that pharmaceutical companies can operate internationally, avoiding the potentially costly risk of violations. Detailed and holistic, the book will be an essential resource to pharmaceutical researchers and manufacturers, as well as an important resource for students and scholars in the field.
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.
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
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.
