Understanding Pharmaceutical Standards and Regulations
Insights Towards Best Practice
1st Edition
Published on 24. June 2025
Book
Hardback
292 pages
978-1-032-81704-0 (ISBN)
Description
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 is an essential resource to pharmaceutical researchers and manufacturers, as well as an important resource for students and scholars in the field.
More details
Language
English
Place of publication
London
United Kingdom
Publishing group
Taylor & Francis Ltd
Target group
College/higher education
Professional and scholarly
Postgraduate and Professional Reference
Illustrations
29 s/w Abbildungen, 2 s/w Photographien bzw. Rasterbilder, 27 s/w Zeichnungen
27 Line drawings, black and white; 2 Halftones, black and white; 29 Illustrations, black and white
Dimensions
Height: 235 mm
Width: 157 mm
Thickness: 21 mm
Weight
596 gr
ISBN-13
978-1-032-81704-0 (9781032817040)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Other editions
Additional editions
Navneet Sharma | Vikesh Kumar Shukla | Sandeep Arora
Understanding Pharmaceutical Standards and Regulations
Insights Towards Best Practice
Book
06/2025
1st Edition
Routledge
€91.60
Shipment within 10-20 days
Navneet Sharma | Vikesh Kumar Shukla | Sandeep Arora
Understanding Pharmaceutical Standards and Regulations
Insights Towards Best Practice
E-Book
06/2025
1st Edition
Routledge
€82.99
Available for download
Navneet Sharma | Vikesh Kumar Shukla | Sandeep Arora
Understanding Pharmaceutical Standards and Regulations
Insights Towards Best Practice
E-Book
06/2025
1st Edition
Routledge
€82.99
Available for download
Persons
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.
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.
Content
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
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