Validation of Active Pharmaceutical Ingredients

Validation of Active Pharmaceutical Ingredients
Author :
Publisher :
Total Pages : 594
Release :
ISBN-10 : 0367801205
ISBN-13 : 9780367801205
Rating : 4/5 (205 Downloads)

Book Synopsis Validation of Active Pharmaceutical Ingredients by : Ira R. Berry

Download or read book Validation of Active Pharmaceutical Ingredients written by Ira R. Berry and published by . This book was released on 2001 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: Much has happened in the area of bulk pharmaceutical good manufacturing practice (GMP) and validation since the first publication of Validation of Active Pharmaceutical Ingredients. Revised, updated, and expanded, this second edition includes new chapters addressing postapproval changes, technology transfer, international cGMP guidelines/FDA guidance progress, and facility inspection issues. The basic philosophy and principles of GMP and validation have not changed, but new terminology had been introduced, and old terminology had been better defined, improving the understanding of related concepts and principles. The book gives you a working knowledge of the regulatory process that will facilitate your organization's compliance with regulations.


Validation of Active Pharmaceutical Ingredients Related Books

Validation of Active Pharmaceutical Ingredients
Language: en
Pages: 594
Authors: Ira R. Berry
Categories: MEDICAL
Type: BOOK - Published: 2001 - Publisher:

DOWNLOAD EBOOK

Much has happened in the area of bulk pharmaceutical good manufacturing practice (GMP) and validation since the first publication of Validation of Active Pharma
Handbook of Validation in Pharmaceutical Processes, Fourth Edition
Language: en
Pages: 1062
Authors: James Agalloco
Categories: Medical
Type: BOOK - Published: 2021-10-28 - Publisher: CRC Press

DOWNLOAD EBOOK

Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edi
Active Pharmaceutical Ingredients
Language: en
Pages: 368
Authors: Stanley Nusim
Categories: Medical
Type: BOOK - Published: 2005-05-25 - Publisher: CRC Press

DOWNLOAD EBOOK

Focusing on the three most critical components that successfully bring an API to market-process development, manufacturing, and governmental regulation and appr
ICH Quality Guidelines
Language: en
Pages: 737
Authors: Andrew Teasdale
Categories: Medical
Type: BOOK - Published: 2017-09-29 - Publisher: John Wiley & Sons

DOWNLOAD EBOOK

Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integra
Active Pharmaceutical Ingredients
Language: en
Pages: 0
Authors: Stanley Nusim
Categories: Drug development
Type: BOOK - Published: 2010 - Publisher:

DOWNLOAD EBOOK