The drug product stability studies are the most resource intensive activities in the drug development process. For this reason, the scrutiny of the FDA review of this section during an application review cannot be over emphasized. However, there are compliance issues that pharmaceutical companies having difficulty to avoid, such as:
- Improper sampling of registration batches
- Inadequate tracking of samples
- Improper storage of samples
- Inadequate labeling of those samples
- Improperly calibrated stability chambers
- Deviation from scheduled test dates
- Use of unvalidated test methods
- Inadequate investigations of Out-Of-Specifications results
- Setting expiration dates that are not supported by available data.
Synergy Bioscience has the technical expertise to develop and implement a custom designed and compliant Stability program for your drug product in a way that will ensure smooth approval of your drug product application. We will write the Stability Program protocol, define the required samples, develop and validate the required analytical methods, verify that the stability chambers are properly calibrated and ready for the storage of your samples, monitor the storage conditions, review and evaluate the analytical results, compile the data and write the Stability Report for your filing.
Synergy Bioscience provides cGMP consulting stability studies to support our customers’ drug development and clinical trials for estimation of shelf-life. The stability consulting experts undertakes the stability studies for API, intermediates, drug product, placebo and reference standard. Our services include :
- Real time, long term stability studies
- Forced degradation studies
- Initial testing of stability indicating methods
- Freeze-thaw stability studies
- Photo-stability testing
Our stability experts design studies specific to your project needs with analyses of those attributes that are susceptible to change during storage. Our experienced analytical staff are available for any additional services such as method development or validation activity.