Final Concept Paper ICH Q12 to Pharmaceutical Product Lifecycle
The ICH Steering Committee has endorsed the final concept paper Q12 “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management”. According to the ICH this new document shall provide guidance on a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the lifecycle of a product.
The proposal is expected to tackle the current lack of a harmonised approach on technical and regulatory considerations for lifecycle management. While the concepts in ICH Q8-Q11 provide opportunities for a more science and risk-based approach for assessing changes across the lifecycle, there are still several gaps as the main focus to date has focused on early stages of the lifecycle.
The intention behind ICH Q12 is to promote innovation and continual improvement and strengthen quality assurance and reliable supply of product. This also includes proactive planning of supply chain adjustments and will allow regulators (assessors and inspectors) to better understand the firms Pharmaceutical Quality Systems for management of post-approval CMC changes. Therefore, ICH Q12 is the logical continuation of the ICH Q8 – Q11 Guidelines.
An adoption of a Step 2-document is planned for 2016.
For more detailed information please refer to the 4 page concept paper published by the ICH.
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