According to the ICH guideline Q1A(R2) adopted by the FDA and EMA, the goal of stability testing is to demonstrate “how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors, such as temperature, humidity and light.” To support a stability study, analytical methods using HPLC, LC/MS and GC are used to test for degradation products apart from tests to determine the sterility of the substance and whether the container or packaging of the final commercial product is compromised.
Understandably, the FDA and other regulatory agencies require this data as part of a registration application for the drug substance or product. Usually, pharmaceutical companies begin stability studies during clinical trials and manufacturing and some even continue these studies after gaining approval.
Pharmaceutical companies arrive at optimum storage conditions and the expiration date of a drug substance or drug product which can be seen commonly on drug labels after collecting stability data over months to years. This data includes the effects of environmental conditions which can significantly alter the physicochemical characteristics, biological activity and other attributes of the drug substance or product. Stability studies are performed for medical devices and raw materials as well.
The ICH Q1A(R2) is a good place to begin since it recommends factors and tests to be considered for a stability data package and draws upon other guidance documents such as “Photostability Testing of New Drug Substances and Products” specific to different aspects of a stability program.
To conclude, monitoring the effects of environmental conditions on the quality of a drug product, substance, medical device and raw material is important to ascertain it is suitable for use by consumers or in manufacturing. Pacific BioLabs supports both long term and accelerated stability programs by providing storage in different conditions according to ICH guidelines and analytical and microbiology testing services. For more information, please visit our Stability Testing page.