ICH Q1A outlines the stability testing requirement for a registration application within three areas of the European Union (EC), Japan and the USA. It does not seek to address the testing for registration or export to other areas of the world. The purpose of the stability testing is to provide information on how the quality of a drug substance or drug product varies with time when the environmental factors such as temperature, humidity and light change. Thus, the recommended storage conditions, the re-test periods and shelf lives could be established accordingly.
The guidance provides recommendations on stability studies including selection of batches, container closure system, testing frequency, storage conditions, stability commitment and evaluation. It should be noted that stress testing is recommended for the drug substance, which can help establish the degradation pathways and the intrinsic stability of the molecule and validate the stability indicating power of the analytical procedures used. Photostability testing should be an integral part of stress testing, and it is required for drug products. For both drug substances and drug products, the standard conditions for photostability testing are described in ICH Q1B.
Jordi Labs has been working with pharmaceutical companies for decades and has extensive experience in analytical testing and method validation. We are always ready to provide clients with stability data packages for new drug substances or drug products for registration applications under Q1A guidance.
References:
http://academy.gmp-compliance.org/guidemgr/files/Q1A(R2).PDF
