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GMP Analytical:Stability Studies
PharmaCore can help you satisfy your stability testing and/or storage needs.
We can analyze samples that you store and send to us at intervals as testing is needed. We can store samples for you and either analyze them here or ship them out for testing to an analytical provider of your choice.
PharmaCore can also handle the entire spectrum of stability study activities for you. We can generate a stability study protocol using our format or yours, provide the appropriate storage for your samples, pull and test samples according to specified procedures and the protocol-specified timetable, and finally generate a stability report, which is updated for each new time pull and can include a trend analysis.
Immediate Testing
Samples that come in for immediate testing (e.g., samples that have been
stored at condition and pulled at the test interval) are entered into our sample log and scheduled for testing in compliance with your requirements.
Storage and Testing
Once your samples arrive, they receive a unique identification number and are logged into our stability system. They are then taken to our stability storage area, where our stability scientists place them into the appropriate storage conditions.
Our qualified stability storage chambers offer temperature and humidity conditions that are fully compliant with ICH guidelines:
Our stability storage chambers are secured against uncontrolled entry and
monitored 24/7 by our validated BAS system for alarm conditions. A value outside of the predetermined limits results in an alarm condition and causes the system to "call" a list of qualified PharmaCore responders to notify them of the alarm condition. Primary stability storage condition data are captured via a manual system of 7-day chart recorders that continuously log and document the conditions. The charts are reviewed on an ongoing basis by our scientists to assure the quality of the chamber performance. The entire stability chamber facility is equipped with a backup power source, and the monitoring system is on an uninterruptible power supply.
Samples are pulled as scheduled and logged for testing into our sample log. All steps of the storage and testing process are tightly controlled and accurately documented.
We will use procedures you specify to complete your analyses. Or if required, we can develop and validate a procedure specifically for your product or bulk drug substance.
Our experienced scientists will call you to discuss any analytical problems or results that seem unusual. We encourage your close review of the data we collect on your project.
PharmaCore's scientists bring a wealth of real-world experience to the table to help meet your needs. Our analytical operations are based on written, detailed SOPs and stringent quality assurance practices, and all of our work is performed in compliance with cGMP requirements.
We welcome client visits or audits to review our standard operating procedures,
to verify our strict compliance with current GMPs, and to demonstrate our
experience in stability studies.
For more information on our method development and validation capabilities
or any of our pharmaceutical capabilities, please call PharmaCore at 336-841-5250, extension 159 (Mark Shapiro, Director GMP Analytical) or extension 101 (Kelly Tilyard, Marketing Manager).
