Validation of Active Pharmaceutical Ingredients: 1st Edition (Hardback) book cover

Validation of Active Pharmaceutical Ingredients

1st Edition

Edited by Ira R. Berry, Daniel Harpaz

CRC Press

618 pages

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Hardback: 9781574911190
pub: 2001-12-31
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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

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology
SCIENCE / Chemistry / General