Stability testing has a distinct purpose for drug substances and drug products. When testing for stability, we are testing for the quality of a drug with varying environmental factors such as temperature, humidity and light. We conduct this testing so that we can evaluate the shelf life of a product or API as well as make a determination of the retest period if applicable.
A stability study should incorporate the drug substance or drug product factors that will affect the product quality, efficacy and safety. It is important to measure physical, chemical, biological and microbial properties.
ICH Q1A(R2) delineates specific conditions that can be used in stability programs. The conditions change for different climatic zones therefore the world is divided into four climatic zones I-IV.
Primera is a partner you can depend upon. We have a great deal of experience in transferring, developing, qualifying, and validating stability-indicating methods that are phase appropriate for your studies.
Once methods are transferred or validated, Primera will work with our client to develop the stability protocol that delineates the requirements of the stability program. Both Primera and our client must sign off on the protocol to ensure that all parties agree to the program.
Our studies are carefully logged into our iStability LIMS system. The iStability LIMS is part 11 compliant and allows us to log all our studies into the system for tracking and reporting. We can also offer you trending data for your evaluation.
Primera maintains the following ICH stability storage conditions, and has the capability to set our stability chambers at custom conditions.
Both our Princeton and Cranbury facilities have abundant stability sample storage. Our chambers are qualified and maintained in-house by trained metrologists, and are securely locked and configured so that we can handle controlled substances Schedules I-V. In addition, all chambers are continuously monitored using the state-of-the-art Vaisala Veriteq system.
As an extra measure of securing your stability samples, Primera has installed automatic generators that run on natural gas directly connected to the utility company in the event of a power outage. These generators are tested on a routine basis to insure their functionality.
At times, either numerous formulations may be viable for drug development or you need to determine the stability characteristics of an API or drug product quickly. When faced with multiple formulations or a need for a quick determination of stability characteristics, Accelerated Predictive Stability can be used. Primera can offer our client, in addition to the typical ICH stability conditions, special storage conditions for the drug substance and drug products to support your accelerated stability assessment programs (ASAP). Many different combinations of the temperature and relative humidity storage conditions can be achieved.
The above are typical studies that Primera offers, however, we can design and implement custom studies to meet your drug substance or drug product needs.