Drug regulatory affairs deals with a very important aspect of drug development i.e. determination of the shelf life of the drug. A lot many companies tend to skip and ignore several points in the guidelines dealing with the shelf life analysis making it very necessary to bring about a close check over it. The design and execution of the analytical study should strictly follow all the principles mentioned in the parent guidance issued by FDA and WHO.
The design of the study should be divided into batches constituting studies based upon several outlined variables. As per the International Conference on Harmonization (ICH) Guideline: Q6A- “Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances have provided general guidance for setting specifications for new drug substances and drug products, but have not provided statistical methods for integrating stability results into the process.”
Based upon these regulatory guidelines the process can simplified as below:
• Gathering knowledge about the product and its degradation
• Finding interactions between excipients and API
• Investigating different package dresses
• Establishing expiration dating period
• Determining storage conditions
• Establishing regulatory specifications derived from a consideration of available stability data
Following a systematic approach in presentation and evaluation of the stability information is a must to get the required approval for the drug to be released in market.