Technical Report No. 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC): Chemistry, Manufacturing and Controls Documentation

PDA Technical Report 38, Manufacturing Chromatography Systems Postapproval Changes (ChromPAC): Chemistry, Manufacturing and Controls Documentation, prepared by the PDA Manufacturing Chromatography Systems PAC Task Force.

This Technical Report addresses post-approval changes to drug substance manufacturing processes for chromatography systems and outlines in change tables the recommended test documentation in support of the changes.

This technical report is issued to provide pharmaceutical manufacturers with recommendations on postapproval changes for chromatographic manufacturing systems. Improvement of product quality and process economics, and increase in production yield and/or global harmonization of operating parameters, are the main reasons for introduction of chromatography system changes. The intention of the document is to provide manufacturers with clarity on the appropriate test documentation when reporting changes to chromatographic operations in an approved manufacturing process, while ensuring patient safety, drug efficacy, and quality. This document provides recommendations for post-approval changes to manufacturing process chromatography systems in the production of drug substance that is used for both chemically synthesized drug products and human-specified biological products as outlined in 21 CFR 601.2 (with the exception of therapeutic DNA plasmid products) regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).

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2006. Volume 60 No. S-1.

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