Stability Testing Software for Pharmaceutical Industry
Stability studies are conducted in the Life Sciences industry to better understand drug product behaviour under various storage environments throughout its shelf life. Stability studies aid in ensuring the effectiveness of a product. Pharmaceutical industries place a high premium on product stability testing to confirm that they adhere to established processes and standards.
For each new drug product in the Pharmaceutical, Contract Research Organization (CRO), Biotech, and Contract Development and Manufacturing Organization (CDMO) Industries, three batches of samples are reserved for stability studies (accelerated, intermediate, and long-term). Subsequently, at least one batch each year of each product is designated as an exhibit batch and is committed to Long Term Conditions. According to the ICH (Q1A) and ICDRA recommendations, a Stability procedure for each product code, and the stability conditions and intervals must be established.
The initial frequencies to be used for a long-term stability study are 3,6,9,12,18, 24, 36, and 48 months. The frequencies for Intermediate are Initial, 3, 6, 9, and 12 months. The frequency for accelerated stability must be Initial, 1, 2, 3, and 6 months. Following that, any changes in composition, manufacturing method, API source, manufacturing equipment, or batch size will necessitate new stability studies.
Stability testing’s continuance in the pharmaceutical industry indicates that it is a critical procedural element of the current pharmaceutical development program for new drugs and formulations.