ICH Stability Storage
ICH stability and sample storage are essential considerations in the pharmaceutical and biotechnology industries. The International Council for Harmonization (ICH) has developed guidelines for stability testing of new drug substances and products to ensure their quality, safety, and efficacy over time.
The ICH guidelines provide specific recommendations for stability testing and sample storage, including the number of samples to be tested, the testing intervals, and the analytical methods. Regulatory agencies worldwide recognize and follow these guidelines, ensuring that pharmaceutical and biotech products are safe, effective, and high-quality.
CCIT Study: ICH Stability and Sample Storage
Stability testing involves subjecting the drug substance or product to various environmental conditions – such as temperature, humidity, and light – to determine its shelf life and storage requirements. The results of these tests are used to establish appropriate storage conditions and expiration dates for the drug substance or product.
Elevate the integrity of your pharmaceutical and biotechnological products with Gateway Analytical’s premier sample storage solutions. Our state-of-the-art refrigeration, freezing, and cryogenic capabilities ensure optimal preservation conditions, safeguarding the stability and quality of your critical samples. With rigorous monitoring and meticulous documentation, we guarantee the traceability and integrity of your assets. Trust Gateway Analytical to be the guardian of your research and development endeavors, where every sample’s potential is maximized under our expert care.
