Issue Date: May 11, 2021
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Quality
Status: Final
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Guidance for Industry: Guidance for Industry
This guidance provides a framework to facilitate the management of postapproval chemistry, manufacturing, and controls (CMC) changes in a more predictable and efficient manner. A harmonized approach regarding technical and regulatory considerations for lifecycle management will benefit patients, industry, and regulatory authorities by promoting innovation and continual improvement in the pharmaceutical sector, strengthening quality assurance, and improving supply of medicinal products.
Download the Guidance Document
