17/18 March 2021
Update: There is a new article available: Now online: Draft ICH Q12
ICH has just published a Final Concept Paper for a new ICH Q12 guideline: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle.
Currently, there is a lack of a harmonised approach to technical and regulatory considerations for the lifecycle management of pharmaceutical products. Although there are concepts in ICH Q8, Q9, Q10 and Q11 for a more science and risk-based approach for assessing changes across the lifecycle, several gaps exist which hinder a full realization of the benefits intended. The original aim of 'operational flexibility' in post-approval changes has not been achieved yet. The main focus at ICH to date is on early stages of the product lifecycle, especially on development and launch.
A similar focus is now needed for the commercial manufacturing phase in order to fill these gaps. Furthermore, there is an inconsistent utilization of post-approval change management plans and comparability protocols. The pharmaceutical industry needs a more strategic manner to prospectively manage future changes.
The proposed ICH Q12 Guideline is intended to work with ICH Q8 to Q11 Guidelines and will provide a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. This guideline will promote innovation and continual improvement, and will allow regulators (assessors and inspectors) to better understand post-approval CMC changes.
The new ICH Q12 guideline will foster a more efficient regulatory evaluation, both in review and inspection, and will address these topics:
This lifecycle management guidance will also support the implementation of innovative technologies such as Process Analytical Technology (PAT) and Continuous Manufacturing, and will also facilitate "operational flexibility".