1st Edition
Understanding Pharmaceutical Standards and Regulations Insights Towards Best Practice
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.
1. US Pharma Manufacturing Standards: Cfr 210 & 211
Afifa Akram, Shubham J. Suryawanshi , Navneet Sharma , Vikesh Kumar Shukla, and Sandeep Arora
2. A Comprehensive Review on the Good Manufacturing Practices Standards: Directive 91/356 of the European Commission
Simran Dixit, Shubham J. Suryawanshi, Sandeep Arora, Navneet Sharma, and Vikesh Kumar Shukla
3. Integration Of Cgmp & Gamp-5 In Pharmaceutical Manufacturing
Simran Yadav, Shubham J. Suryawanshi, Sandeep Arora, Vikesh Shukla, Navneet Sharma, and Nitin Sharma
4. Medical Device and Ivds Global Harmonization Task Force Guidance Documents
Utkarsh Vashishtha, Shubham J. Suryawanshi, Vikesh Kumar Shukla, Navneet Sharma, and Sandeep Arora
5. Current Scenario and Future Perspective of Good Laboratory Practices
Shubhangini Chauhan, Shubham J. Suryawanshi, Chahat Tyagi , Vikesh Shukla, Navneet Sharma, and Sandeep Arora
6. Advancing Laboratory Excellence: A Comprehensive Review of Quality Audits
Simran Kaur, Shrutika Sharma, Vishesh Sahu, Sandeep Arora, Navneet Sharma, and Vikesh Kumar Shukla
7. Introduction of Good Automated Laboratory Practices (Galp): Principles and Comparative Analysis Across Regulatory Authorities - Usfda, Ema, Cdsco, And Tga
Radhakrishan Gaur, Shrutika Sharma, Sandeep Arora, Navneet Sharma, and Vikesh Kumar Shukla
8. A Framework to Understanding E-Records Under 21cfr Part 11
Prachi Sharma, Shrutika Sharma, Sandeep Arora, Navneet Sharma, and Vikesh Kumar Shukla
9. Current Trends in Good Distribution Practices (Gdp)
Mansi Sharma, Shrutika Sharma, Manan Grover, Sandeep Arora, Navneet Sharma, and Vikesh Kumar Shukla
10. Navigating The Pharmaceutical Supply Chain: Ensuring Integrity Amidst Challenges
Manan Grover, Shrutika Sharma, Mansi Sharma, Vikesh Kumar Shukla, Harjinder Kaur, and Navneet Sharma
11. Optimizing Pharmaceutical Quality: Exploring Out of Specification, Total Quality Management, Change Control
Vishesh Sahu, Siddharth Jain, Navneet Sharma, Harjinder Kaur, and Vikesh Kumar Shukla
12. Insights Into the Six Sigma Concept
Kabil Malhotra, Sonal Sharma, Navneet Sharma, Sandeep Arora, and Vikesh K. Shukla
13. Good Regulatory Practices and Validation Plans in Pharmaceutical Practices
Chahat Tyagi, Siddharth Jain, Shubhangini Chauhan, Sandeep Arora, Navneet Sharma, and Vikesh Kumar Shukla
14. Critical Utility Validation: An Innovative Approach to Pharmaceutical Best Practices
Sonal Sharma, Siddharth Jain, Navneet Sharma, Sandeep Arora, and Vikesh K. Shukla
15. International Council of Harmonization: Reception to Implementation
Deepak Dhandia, Siddharth Jain, Vikesh Kumar Shukla, Navneet Sharma, and Pooja YadavcSandeep Arora
16. ISO-13485 and Schedule MIII – Quality Management System
Deepak Dhandia, Siddharth Jain, Vikesh Kumar Shukla, Navneet Sharma,Pooja Yadav, and Sandeep Arora
Biography
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.
