Understanding the ICH Q12 Guideline: Enhancing Pharmaceutical Lifecycle Management
The International Council for Harmonisation (ICH) Q12 guideline, titled “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management,” provides a framework to streamline the management of post-approval changes for pharmaceutical products. Finalized in 2019, ICH Q12 aims to harmonize regulatory expectations, promote innovation, and ensure a consistent supply of high-quality medicines. By introducing tools like … Read more