eBook - ePub
Understanding Pharmaceutical Standards and Regulations
Insights Towards Best Practice
- 272 pages
- English
- ePUB (mobile friendly)
- Available on iOS & Android
eBook - ePub
Understanding Pharmaceutical Standards and Regulations
Insights Towards Best Practice
About this book
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.
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Information
Topic
MedicineSubtopic
OperationsTable of contents
- Cover
- Half Title
- Title Page
- Copyright Page
- Table of Contents
- List of figures
- List of tables
- List of contributors
- 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 to Good Automated Laboratory Practices (GALPs): Principles and Comparative Analysis across Regulatory Authorities – USFDA, EMA, CDSCO, and TGA
- 8 A Framework to Understanding E-Records under 21 CFR Part 11
- 9 Current Trends in Good Distribution Practices (GDPs)
- 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 for Harmonization: Reception to Implementation
- 16 ISO-13485 and Schedule M-III – Quality Management System
- Index
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Yes, you can access Understanding Pharmaceutical Standards and Regulations by Navneet Sharma,Vikesh Kumar Shukla,Sandeep Arora in PDF and/or ePUB format, as well as other popular books in Medicine & Operations. We have over 1.5 million books available in our catalogue for you to explore.