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 pharmaceutical companies and their 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, the 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 also demonstrates how to increase product and process knowledge which is helpful for understanding the post-approval changes required for regulatory submission as well as the description of the level of reporting categories for such changes. This guideline also helps 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 helps the management of the industry to understand the management of post-approval changes and the establishment of the relationship between the pharmaceutical industry and different regulatory authorities.
Categorization of Post-Approval CMC Changes
These tools help in creating a framework that covers the different types of risk-based approaches 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 the risk involved in changes. This involves various steps i.e. requesting regulatory authorities for prior approval for CMC changes or notifying the authorities for changes or recoding the changes with the timeframes for decision. Changes that are categorized as major or sufficient risk are required prior approval from authority while the low to moderate risks are judged are not required prior approval.
Established Conditions (ECs)
This tool 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 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 includes 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 that which industry wants to implement during the commercial phase of products. In PACMP, the first step includes the submission of the protocol which includes proposed changes with the scientific rationale, studies to be conducted, and the acceptance criteria for accepting the changes. The second step includes the execution of tests and studies included in the protocol. If the results are met under acceptance criteria the final information is submitted to the authority for review.
Product Lifecycle Management (PLCM) Document
This document serves as a centralized document that includes all established conditions and also reports the changes in the EC during the life cycle of products. All the ECS should be listed in this document with a detailed justification for the categorization of different risks associated. The protocol includes the changes required and studies should be conducted as the part of changes. All the development studies like manufacturing process monitoring, and additional studies that are performed during the commercial phase of the product, should be listed in this document.
Pharmaceutical Quality System (PQS) and Change Management
PQS is the primary responsibility of the company to maintain it effectively. This system includes change management which is enabled by management knowledge and management review. Internal company processes and regulatory processes are interlinked in 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 remain unchanged by ICH Q12 guidelines.
Structured Approaches for Frequent CMC Post-Approval Changes
This guideline helps in adopting an approach to accomplish certain CMC changes, needed for products whose marketing authorization did not involve the identification of ECs with associated reporting categories. The analytical methodology must be maintained for existing authorized products and they should be updated as to 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 helps in determining the data needed for submission to the regulatory authority to support a post-approval change and these changes are established by regional regulations and guidance. Different approaches to the design of 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:
- ICH harmonized guideline Q12 “ Technical and Regulatory considerations for Pharmaceutical Product lifecycle management”
- https://database.ich.org/sites/default/files/Q12EWG_Step4_IntroTrainingPresentation_2020_0206.pdf
- https://database.ich.org/sites/default/files/Q12_Annexes_Step4_2019_1119.pdf
- https://www.fda.gov/media/94066/download
- https://www.fda.gov/files/drugs/published/
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