ICHQ14 in Analytics

Written By Makaylah Dixon

A Balanced Approach to Real-Time Release Testing (RTRT)

If you are thinking about how to implement ICHQ14 into your analytical workstream, this paper presents some opportunities to blend in the old with the new. Adaptation of your existing analytical framework can leverage much of your past experience, but the systematic approach to ICHQ14 may require substantial training, development of new documentation, and reworking existing analytical procedures.

I enjoyed the pros and cons list and the summary paragraph, which can help guide you to the future of real-time release. If this is something you're thinking about, give me a call — I may be able to help you develop a pathway to ICHQ14 implementation success.

Read the full article here: Challenges in Developing Analytical Procedures with the New ICH 014 Guideline

This blog post references the following industry publication:
Pharmaceutical Outsourcing Editorial Team. (2025). Pharmaceutical Outsourcing – Q3 2025. CompareNetworks / Nxtbook. Retrieved from https://www.nxtbook.com/comparenetworks/PharmaceuticalOutsourcing/pharmaceutical-outsourcing-q3-2025/index.php#/p/16
Used under educational and commentary purposes.

Makaylah Dixon
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