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- Title
Approved drug product lifecycle management for US generic submission.
- Authors
Venkatesh, M. P.; Anjana, B.; Swathi, K. C.; Kumar, T. M. Pramod
- Abstract
Introduction: Product lifecycle management is a business strategy that pharmaceutical manufacturers use to maintain revenue streams from their leading drug products. Post approval changes are an integral part of pharmaceutical product life cycle management. To ensure the safety of the innovations, product lifecycle management (PLM) will be included as a strategy for prolonging the stay of product in the market. Objectives: This study envisages about the Chemistry, Manufacturing and Controls (CMC) changes across the product lifecycle. Discussion: Level of changes is categorized as major, moderate and minor based on its effect on product quality and performance. Before submitting a PAS, if the change to be made is major, a prior approval from FDA is required. Approved drug PLM for the US generic submissions includes: Post-approval changes, risk evaluation and mitigation strategy, amendments and supplements, post-marketing periodic safety reports and field alert report. Conclusion: Changes are inevitable in pharmaceutical industry in fact they are very much necessary for the continuous quality improvement of the product. The applicant should think back the impact of the change on the quality attributes of the final product and should report the changes for an approved ANDA for regulatory authorities in a timely manner to be in compliant with FDA.
- Publication
Drug Invention Today, 2020, Vol 13, Issue 2, p300
- ISSN
0975-7619
- Publication type
Academic Journal