Cantitate/Preț
Produs
Total produse
Vezi coșul
Understanding Pharmaceutical Standards and Regulations: Insights Towards Best Practice de Navneet Sharma

Understanding Pharmaceutical Standards and Regulations: Insights Towards Best Practice

Editat de Navneet Sharma, Vikesh Kumar Shukla, Sandeep Arora
en Limba Engleză Paperback – 25 noi 2024
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.
Citește tot Restrânge

Preț: 35663 lei

Preț vechi: 46129 lei
-23% Nou

Puncte Express: 535
Preț estimativ în valută:
6825€ • 7090$ • 5669£

Carte nepublicată încă


Wish list
Gift list
Am citit!
Adaugă în listă
Doresc să fiu notificat când acest titlu va fi disponibil:
Trimite
Preluare comenzi: 021 569.72.76

Specificații

ISBN-13: 9781032814124
ISBN-10: 1032814128
Pagini: 272
Ilustrații: 58
Dimensiuni: 152 x 229 mm
Ediția:1
Editura: Taylor & Francis
Colecția Routledge
Locul publicării:Oxford, United Kingdom

Public țintă

Postgraduate and Professional Reference

Cuprins

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

Notă biografică

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.

Descriere

This resource provides a guide to the regulations and standards which govern the international pharmaceutical industry. Featuring explanations of regulations and strategies to maintain compliance, the book covers the key principles of best-practice for laboratory research, manufacturing and distribution.