According to the ICH guideline Q1AR2 adopted by the FDA and EMA, the objective of stability testing is to show how the quality of a drug substance or drug product varies with time under the influence of many different environmental factors, such as humidity, temperature and light. To encourage a stability study, analytical methods using HPLC, LC/MS and GC are utilized to test for degradation products besides tests to find out the sterility of their substance and if the container or packaging of the final commercial product is compromised. Understandably, the FDA and other regulatory agencies need This information as part of a registration application for the drug product or substance. Normally, pharmaceutical firms begin stability studies during clinical trials and production and some even continue these studies after gaining acceptance.
Pharmaceutical companies arrive at optimal storage conditions and the expiry date of a drug substance or drug product that could be seen commonly on medication labels after amassing stability data over months to years. This information includes the effects of environmental conditions which can significantly alter the physicochemical characteristics, biological activity and other aspects of the drug substance or product. Stability studies are performed for medical devices and raw materials too. The ICH Q1AR2 is a good place to begin because it recommends Variables and tests to be considered for a stability data package and attracts additional guidance documents such as Photostability Testing of New Drug Substances and Products specific to various facets of a stability program.
In Conclusion, monitoring the effects of environmental conditions About the quality of a drug product, chemical, medical apparatus and raw material is Important to ascertain it is acceptable for use by customers or in manufacturing. Pacific Biolabs supports both long term and accelerated stability programs by Providing storage in various states according to ICH guidelines and Analytical and microbiology Stability Testing solutions. For more information, please Stop by our Stability Testing page. Stability testing may also be used to ascertain acceptance criteria for release testing. Specifications that stay stable during stability storage and evaluation might not have to be contained in discharge testing, whereas more varying dimensions may indicate requiring either batch-by-batch or periodic testing of the ready-for-market medication product before supply.