Understanding Pharmaceutical Standards and Regulations

Insights Towards Best Practice

Häftad, Engelska, 2025

AvNavneet Sharma,Vikesh Kumar Shukla,Sandeep Arora

1 279 kr

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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.

Produktinformation

Utgivningsdatum2025-06-24
Mått152 x 229 x 18 mm
Vikt570 g
FormatHäftad
SpråkEngelska
Antal sidor292
FörlagTaylor & Francis Ltd
ISBN9781032814124

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Apotek och farmaceuter inom Medicin
Tillverkningsteknik inom Naturvetenskap och teknik
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Farmakologi inom Medicin

1. US Pharma Manufacturing Standards: Cfr 210 & 2112. A Comprehensive Review on the Good Manufacturing Practices Standards: Directive 91/356 of the European Commission3. Integration Of Cgmp & Gamp-5 In Pharmaceutical Manufacturing4. Medical Device and Ivds Global Harmonization Task Force Guidance Documents5. Current Scenario and Future Perspective of Good Laboratory Practices6. Advancing Laboratory Excellence: A Comprehensive Review of Quality Audits7. Introduction of Good Automated Laboratory Practices (Galp): Principles and Comparative Analysis Across Regulatory Authorities - Usfda, Ema, Cdsco, And Tga8. A Framework to Understanding E-Records Under 21cfr Part 119. Current Trends in Good Distribution Practices (Gdp)10. Navigating The Pharmaceutical Supply Chain: Ensuring Integrity Amidst Challenges11. Optimizing Pharmaceutical Quality: Exploring Out of Specification, Total Quality Management, Change Control12. Insights Into the Six Sigma Concept13. Good Regulatory Practices and Validation Plans in Pharmaceutical Practices14. Critical Utility Validation: An Innovative Approach to Pharmaceutical Best Practices15. International Council of Harmonization: Reception to Implementation16. ISO-13485 and Schedule MIII – Quality Management System

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