Product Quality Research Initiative and Bulk Actives Post Approval Change
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Product Quality Research Initiative and Bulk Actives Post Approval Change Daniel H. Gold and Stephen Byrn Drug Information Journal 1999 33: 777 DOI: 10.1177/009286159903300317 The online version of this article can be found at: http://dij.sagepub.com/content/33/3/777
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0092-8615199 Copyright 0 1999 Drug Information Association Inc.
Drug Informarion Journal. Vol. 33, pp. 1 7 1 784. 199Y Printed in the USA. All rights reserved.
PRODUCT QUALITY RESEARCH INITIATIVE AND BULK ACTIVES POST APPROVAL CHANGE DANIELH. GOLD,PHD D. H. Gold Associates, Inc.
STEPHENBYRN,PHD Purdue University
Based upon the success achieved by Scale-Up and Post Approval Change (SUPAC) in reducing the regulatov burden f o r drug product postapproval mnnufacturing change. a Food and Drug Administration (FDA),industry, nnd academic collaborative arrangement called the Product Quality Research Initiative (PQRI) was ,founded. Its objective was to .foster and execute reseurch programs designed to permit a broader application of the SUPAC principles fi)r the regulatory reduction of postapproval manufacturing changes to drug substance and drug product operations. In the drug substance urea, the PQRI Technicul Committee developed un umbrellu hypothesis and from that, three research initiatives to use us the core for the structure of specific reseurch programs. The projects relate to: 1. The significunce of specifications, 2. Drug substance physical properties, and 3. Drug substunce impurities. The following paper discusses these aspects of PQRI, affords a detailed perspective of the objectives and organization of PQRI, and explains the relationship between Rulk Actives Post Approval Change (BACPAC) and SUPAC. Key Words: BACPAC; PQRI; Drug substance; Specifications; Impurities; Physical properties
DISCUSSION OVER MANY YEARS, a large number of drug substance industry practitioners have loudly complained and protested about the requirement to obtain prior FDA approval for changes to approved drug substance manufacturing processes. FDA review of these requested process changes, filed in the form of
Presented at the DIA Fourth Symposium on Active Pharmaceutical Ingredients ( APIs): “Issues at the Development, Production, Regulatory Interface,” November 8-1 1, 1998, Baltimore. Maryland. Reprint address: Daniel H. Gold, D. H. Gold Associates, Inc., 441 Alpine Terrace. Ridgewood, NJ 07450 or Stephen R. Byrn, Department of Industrial and Physical Pharmacy, Purdue University. West Lafayette, IN
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