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ICH STABILITY TESTING

Gathering stability testing data on drug products or drug substances is a necessary step in the drug approval process. Guidelines for stability testing data as listed in ICH Q1A(R2) have been adopted by the European Union, U.S. FDA, and the Japanese Ministry of Health, Labor, and Welfare. The guidelines give storage conditions and times for long-term, intermediate, and accelerated stability studies. Below are ICH general storage conditions.

• Long-term studies - 25C and 60% Relative Humidity (RH) for 12 months, or 30C and 65% RH for 12 months.
• Intermediate studies - 30C and 65% RH for 6 months.
• Accelerated studies - 40C and 75% RH for 6 months.

Other conditions may be appropriate. For instance, drug product intended for refrigerated storage would undergo long-term storage at 5C for 12 months.

During stability studies, it is necessary to demonstrate that the drug substance or product continues to meets its specifications. Samples are taken at specified time-points and analytically tested to ensure continued viability. For a six month accelerated study, samples are typically tested at 1.5 months, 3 months, 4.5 months, and 6 months. Additionally, for finished drug products, it is necessary to ensure sterility. This can be done through sterility testing or by testing the drug packaging or container closure system for integrity.

ICH stability data is required as part of an IND or CTA (EU) submission. Since long-term studies take 12 months or longer, it is prudent for companies to begin gathering stability data once a suitable drug candidate has been selected.

PBL can provide clients with temperature and humidity controlled chambers for storing samples for ICH stability studies, as well as various types of aging studies on products and packaging. All chambers are monitored 24/7 by a Rees environmental system.

More detailed information can be found in the ICH guideline Q1A(R2) (PDF).

Stability Testing Conditions

• 25C / 60% Relative Humidity
• 40C / 75% Relative Humidity
• Other non-standard temperatures and relative humidites