95. ICH Topic Q 1 A. Stability Testing Guidelines: Stability Testing of New Drug. Substances
K. Huynh-Ba and M. Zahn. Abstract This chapter discusses International Conference of Harmonization (ICH) guidelines that are related to the Stability Sciences. It gives a brief history of how the Q1A was initiated. A summary of Q1A(R2) discusses thoroughly the current regulations that the industry supports and practices.
This revised ICH guidelines regulate the scope necessary for marketing authorization of the stability testing of new active substances and finished medicinal products containing
The following guideline is a revised version of the ICH Q1A guideline and defines the stability data package for a new drug substance or drug product that is sufficient for a registration application within the three regions of the EC, Japan, and the United States.
This Guideline has been revised a second time and has reached Step 4 of the ICH process in February 2003. This Guideline provides recommendations on stability testing protocols including temperature, humidity and trial duration for climatic Zone I and II.

4 Sep 2016 This Presentation includes the description about ICH quality guideline for Stability testing of APIs and FPPs.
1 Feb 2010 The following guideline is a revised version of the ICH Q1A guideline and defines the stability data package for a new drug substance or drug product that is sufficient for a registration application within the three regions of the EC, Japan, and the United States.
17. ICH Q1(R2) Stability testing Guidelines: Stability Testing of New Drug Substances and Products. ICH Step 5. Recommended for Adoption 6 February 2003. Note for Guidance on Stability Testing: Stability Testing of New drug Substances and Products. Revision of ICH Q1A: ?. Section of stress testing of active substance
Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management. Zip with all ICH Quality Guidelines in word format. Q1A - Q1F Stability

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March 2018