Validation of Active Pharmaceutical Ingredients

ISBN-13: 9781574911190 / Angielski / Twarda / 2001 / 618 str.

Santoro; Robin Goldstein; Berry R. Berry

Opis

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. The second edition is fully revised, updated, and expanded to include new chapters addressing postapproval changes, technology transfer, international cGMP guidelines/FDA guidance progress, and facility inspection issues. New terminology has been introduced and the old terminology has been better defined to improve the understanding of related concepts and principles. With this book, readers gain a working knowledge of the regulatory process that will facilitate their organization's compliance.

Spis treści

Introduction, D. HarpazThe 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. KhannaAPI Validation, M. Lazar Active Pharmaceutical Ingredient Valication: An Overview and Comparative Analysis, M.S. LazarImpurities 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. ShirtzExcipients: Facility, Equipment, and Processing Changes, I. Silverstein API Terminology & Documentation, R. Nash

O autorze

Ira R. Berry