Technical & Regulatory considerations for Pharmaceutical Product Lifecycle Management

by Rohit T. Veeprho Laboratories Pvt.Ltd

Product Lifecycle Management(PLM) is the route of handling the entire lifecycle of a product from its beginning, through product machine design and manufacturing procedure, to service and clearance. PLM forms the product information which is the backbone for a pharmaceutical companies and its subsidiaries. It is composed of multiple elements which include: basic technologies and principles (e.g., XML, imagining, association, enterprise application incorporation, etc.), information authoring and analysis tools (e.g., mechanical design, electronics design, software applications, technical literature publishing etc.), principal functions (e.g., data vaults, document and data management, workflow of documents, product structuring, program management, etc.), functional applications (e.g., configuration management, change control of engineering control, etc.), and business solutions (e.g., new product overview, supply chain management, etc.) that incorporate best practices and methods for the products.

ICH guideline Q12 provides an outline to simplify the management of post-approval CMC changes in a more predictable and effective manner. This guideline is also demonstrate how to increase product and process knowledge which is helpful for understanding the post-approval changes require for a regulatory submission as well as the description of the level of reporting categories for such changes. This guideline also help in increasing the industry’s ability to manage many CMC changes effectively under the company’s Pharmaceutical Quality System (PQS) with less need for extensive regulatory oversight prior to implementation.

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