For The Better

4 New ICH Q12 Principles for Pharmaceutical Product Lifecycle Management

April 21, 2020
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The International Council for Harmonisation (ICH) recently issued the Q12 guideline on technical and regulatory considerations for pharmaceutical product lifecycle management. The guideline has now reached Step 4 of the process.

The guideline promotes innovation while strengthening quality assurance to improve management of post-approval changes in chemistry, manufacturing, and control (CMC). The Q12 guideline complements the existing ICH Q8 to Q11 guidelines.

Key ICH principles:

  1. Provides a framework to facilitate the management of post-approval CMC changes in a more predictable and efficient manner
  2. Presents several harmonized regulatory tools and enablers with associated guiding principles
  3. Demonstrates how increased product and process knowledge can contribute to a more precise and accurate understanding of which post-approval changes require regulatory submission
  4. Emphasizes the importance of an effective pharmaceutical quality systems in the management of changes during the product lifecycle

CMC changes vary from low-potential to high-potential risk with respect to product quality, safety, and efficacy. To learn more about Q12 Step 4, visit the ICH website and view the introductory training presentation.

Comprehensive guidance and services:

PerkinElmer offers everything to ensure compliance, from analytical instrumentation to consistent service and support.


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