Technical & Regulatory considerations for Pharmaceutical Product Lifecycle Management

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Considerations for pharmaceutical product lifecycle management
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Introduction 

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 methodsfor 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.

Regulatory Tools and Enablers

The ICH guideline has provided regulatory tools and enablers with the principles which guide the industry. This guidance help the management of industry to understand the management about post approval changes and the establishing the relationship between pharmaceutical industry and different regulatory authorities.

  • Categorization of Post-Approval CMC Changes

This tools help in creating a framework that covers the different type of risk based approach with respect to product quality, safety and availability. This regulatory system allows the pharmaceutical industry to develop and utilize the system which is based on determining risk involved in changes. This involve various steps i.e. requesting to regulatory authorities for prior approval for CMC changes or notifying the authorities for changes or recoding the changes with the timeframes for decision. Changes which are categorized as major or sufficient risk are required prior approval from authority while the low to moderate risk are judged are not required prior approval.

  • Established Conditions (ECs)

This tools helps in establishing the approach to defining which elements in an application are considered necessary to assure product quality and therefore would require a regulatory submission if changed post-approval. These elements are also being defined in this guideline “Established Conditions for Manufacturing and Control”.

  • Post-Approval Change Management Protocol (PACMP)

This tool help in preparing and approving the protocol which normally include the requirements and details of studies needed to implement a change and also this help in establishing an agreement between the regulatory authority and MAH for execution. The protocol should include the CMC change which industry want to implement during the commercial phase of products. In PACMP, the first step include the submission of protocol which include proposed changes with the scientific rationale, studies to be conducted and the acceptance criteria for accepting the changes. Second step include the execution of test and studies included in protocol. If the results are met under acceptance criteria the final information is submitted to authority for review.

  • Product Lifecycle Management (PLCM) Document

This document serve as a centralized document which include all established condition and also reporting the changes in the EC during the life cycle of products. All the ECs should be listed in this document with the detailed justification for the categorization of different risk associated. The protocol include the changes required and studies should be conducted as the part of changes. All the development studies like manufacturing process monitoring, additional studies that are performed during commercial phase of product, should be listed in this document.

  • Pharmaceutical Quality System (PQS) and Change Management

PQS is the primarily responsibility of company to maintain it effectively. This system include the change management which is enabled by management knowledge and management review. Internal company process and regulatory process are interlinked in the knowledge management and change management, where internal change approval and regulatory approval are required.

  • Relationship Between Regulatory Assessment and Inspection

Review of any MAA and the inspection of manufacturing sites are corresponding activities and their roles are remain unchanged by ICH Q12 guideline.

  • Structured Approaches for Frequent CMC Post-Approval Changes

This guideline help in adopting an approach to accomplish certain CMC changes, needed for products whose marketing authorization did not involve identification of ECs with associated reporting categories. The analytical methodology must be maintained for existingauthorized products and they should be updated as on date.  The analytical procedures can be related to the drug substance(s) and finished product.

  • Stability Data Approaches to Support the Evaluation of CMC Changes

This guideline help in determining the data needed for submission to the regulatory authority to support of a post-approval change and these changes are established by regional regulations and guidance. Different approaches to the design of the stability studies, should be scientifically justified. It may include the quality attributes and attributes which are related to shelf life determination related to intended CMC change.  

References:

  1. ICH harmonized guideline Q12 “ Technical and Regulatory considerations for Pharmaceutical Product lifecycle management”
  2. https://database.ich.org/sites/default/files/Q12EWG_Step4_IntroTrainingPresentation_2020_0206.pdf
  3. https://database.ich.org/sites/default/files/Q12_Annexes_Step4_2019_1119.pdf
  4. https://www.fda.gov/media/94066/download
  5. https://www.fda.gov/files/drugs/published/

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