This Guideline (ICH Q12) is proposed to 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 life cycle.
Adoption of this ICH Guideline will promote innovation and continual improvement in the biopharmaceutical sector, and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments.
It will allow regulators (assessors and inspectors) to better understand the firms’ Pharmaceutical Quality Systems (PQSs) for management of post-approval CMC changes.
This Guideline is intended to complement the existing ICH Q8 to Q11 Guidelines, and is composed of a core Guideline and Annexes.
This guideline is also intended to demonstrate how increased product and process knowledge can contribute to a more precise and accurate understanding of which post-approval changes require a regulatory submission as well as the definition of the level of reporting categories for such changes (i.e., a better understanding of risk to product quality).
ICH Q12 Regulatory Tools and Enablers
- Categorization of Post-Approval CMC Changes
- Established Conditions (ECs)
- Post-Approval Change Management Protocol (PACMP)
- Product Lifecycle Management (PLCM) Document
- Pharmaceutical Quality System (PQS) and Change Management
- Relationship Between Regulatory Assessment and Inspection
- Structured Approaches for Frequent CMC Post-Approval Changes
- Stability Data Approaches to Support the Evaluation of CMC Changes
