1st Edition

Validation of Active Pharmaceutical Ingredients

Edited By Ira R. Berry, Daniel Harpaz Copyright 2001
    618 Pages
    by CRC Press

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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.

    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