Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
This topic was endorsed by the ICH Steering Committee in September 2014.
This new Guideline 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 lifecycle.
Adoption of this new 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 new Guideline is intended to complement the existing ICH Q8 to Q11 Guidelines, and is composed of a core Guideline and Annexes.
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Date of Step 4: 20 November 2019
Status: Step 5
Guidelines (Click the links below for complete guidelines)
Endorsed Documents (Click the links below for complete guidelines)
WG Presentations / Trainings (Click the links below for complete guidelines)
Q12 IWG Training on Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management
Further to the Q12 Guideline reaching Step 4 in November 2019, the Q12 IWG was established to prepare a comprehensive training programme and associated materials to facilitate an aligned interpretation and a harmonized implementation of ICH Q12 in ICH and non-ICH regions.
Endorsed Documents (Click the links below for complete guidelines)
*These Guidelines Belongs to ICH website.
