Abstract

GUIDANCE ON STABILITY TESTING: STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS

*Patel Nima Amaratbhai

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Abstract

The purpose of the ICH Q1A revision is to enhance and clarify sections of the stability testing guideline. Key revisions include relocating the section on stress testing of the active substance from the glossary to the main text, aligning test procedures with ICH Q6A, introducing cross- references to other ICH guidelines, and amending testing frequency for accelerated conditions. Storage conditions are now more detailed, specifically addressing low temperature testing and aqueous liquids in semi-permeable containers. Post-approval commitments are clearly defined, and editorial inconsistencies, including glossary updates, have been corrected. Following the adoption of ICH Q1F, changes were made to storage conditions for Climatic Zones III and IV, notably updating intermediate storage to 30°C ± 2°C/65% RH ± 5% RH. Alternative long-term storage conditions were also introduced. Stability studies, governed by regulatory bodies like ICH, WHO, and FDA, are essential to ensure product safety, quality, and efficacy. This paper reviews global guidelines, types of stability studies, and their critical role in pharmaceutical development.

Keywords: Stability studies, ICH Q1A(R), ICH Q1F, pharmaceutical products, stress testing, storage conditions, accelerated testing, semi-permeable containers, post-approval commitment, regulatory guidelines, shelf life, drug substance, drug product, WHO, FDA, CPMP,