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:
Regulatory Dossier
- Reducing the appropriate level of detail and information necessary for regulatory assessment and inspection
in the dossier,
- Post approval changes that facilitate continual improvement and encourage the adoption of innovative
technologies.
Pharmaceutical Quality System aspects (ICH Q10)
- A risk-based change management system for changes,
- Need for a knowledge management system over the product lifecycle.
Post-Approval Change Management Plans and Protocols
- Concept of a post-approval management plan including the assessment by regulatory authorities (assessors and inspectors)
- - Enhanced product development and control strategy approaches (Quality by Design (QbD) providing
- opportunities for scientific and risk based foundations for post-approval change management plans).
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".
For further information please see the complete Concept Paper ICH Q12 as well as the Business Plan.
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