Understanding Pharmaceutical Standards and Regulations (eBook)

Name: Understanding Pharmaceutical Standards and Regulations (eBook)
SKU: 978-1-040-25821-7
Price: 112.85 CHF
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Insights Towards Best Practice

Artikelnummer: 978-1-040-25821-7

Einband: PDF

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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

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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

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Verlag	Taylor & Francis Ebooks
Einband	PDF
Erscheinungsjahr	2025
Seitenangabe	306 S.
Ausgabekennzeichen	Englisch
Abbildungen	29 schwarz-weiße Abbildungen, 2 schwarz-weiße Fotos, 27 schwarz-weiße Zeichnungen
Masse	9'655 KB
Auflage	25001 A. 1. Auflage
Plattform	PDF
Autor	Sharma, Navneet (Hrsg.) / Kumar Shukla, Vikesh (Hrsg.) / Arora, Sandeep (Hrsg.)

Über den Autor Navneet (Hrsg.) Sharma

Navneet Sharma serves as Scientist of pharmaceutical chemistry, biomaterials, and contamination sciences. He holds an M. Pharm from JSS University, a Postgraduate Diploma in Drug Regulatory Affairs from Jamia Hamdard, and a Ph.D. in Pharmaceutical Sciences from the University of Delhi. His doctoral work at INMAS (DRDO) focused on developing topical formulations for chemical, biological, radiological, and nuclear (CBRN) skin decontamination, incorporating toxicological assessments and cellular studies. Dr. Sharma's postdoctoral research at IIT Delhi led to the development of zinc titanate-based biodegradable materials for CBRN decontamination, integrating nanomaterials for improved efficacy and sustainability. Her research focuses on molecular modeling, drug-molecule interactions, and water remediation. She has published extensively, contributed to international collaborations, and holds multiple patents.Mallika Pathak is Professor at the Department of Chemistry, Miranda House, University of Delhi, Delhi, India. He has received numerous honors, including the Australian Leadership Award Fellowship (2013), 'Most Promising Innovation' (2016), and the 'Teaching Excellence Award for Innovation' (2015) from the University of Delhi, India.