Validation of Active Pharmaceutical Ingredients  book cover
1st Edition

Validation of Active Pharmaceutical Ingredients

ISBN 9781574911190
Published December 31, 2001 by CRC Press
618 Pages

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Book Description

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.

Table of Contents

Introduction, D. Harpaz
The Legal Framework for the Regulation of Active Pharmaceutical Ingredients, D. Weeda, A. Tsien, N. O'Flaherty, and R. Hahn
The Legal Basis for Validation, I. Wiesen
Drug Master Files, A. Shaw
FDA's Perspectives on API Manufacturing, cGMP Controls & Validation, E. Martinez
Domestic and Foreign API Manufacturing Facility Audits & Findings, P. Smith
Validation of APIs: A Case Study, N. Khanna
API Validation, M. Lazar
Active Pharmaceutical Ingredient Valication: An Overview and Comparative Analysis, M.S. Lazar
Impurities in Drug Substances and Drug Products, S. Byrn & J. Stowell
Investigating Process Deviations, F. Golden
Technology Transfer: Active Pharmaceutical Ingrediants, B.J. Evanoff and K.L. Hoffman, Jr.
Postapproval Changes to Bulk Drug Substances, E. Sheinin, E. Duffy, K. Srinivasachar & J. Smith
Vendor Qualification and Certification, I.R. Berry
Quality Assurance Systems, F. Radford
Cleaning for Active Pharmaceutical Manufacturing Facilities, W. Hall
Validation of Sterile APIs, R. Kasubick
Validation of Biotechnology Active Pharmaceutical Ingredients, R. Murphy & R. Seely
Microbiological Attributes of Active Pharmaceutical Ingredients, K. McCullough & J. Shirtz
Excipients: Facility, Equipment, and Processing Changes, I. Silverstein
API Terminology & Documentation, R. Nash

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