Blue Stream provides ICH compliant Stability Program Management services; also known as Stability Testing services. Our storage chambers accommodate a number of storage conditions and product packaging formats. We can design or assist in the design, set-up, and management of stability programs, and prepare Stability Program protocols based on industry standards or specific client needs.
Blue Stream's Stability Program Management Services encompass, but are not limited to:
- Stability Program design
- Stability Protocol generation
- Transfer, Development, and/or Validation of all assays to be used in the program
- Execution of all protocols
- Assignment of Stability Program manager (Study Manager)
- Interim time-point reports
- Final Stability Program Report
Stability Program Management at Blue Stream is based on systematic and thorough sample tracking, record keeping, protocol-directed handling of materials, monitored storage, cGMP compliant OOS investigations, seamless communication with Sponsor, etc. Besides performing the required testing at the appropriate time points, we conduct trend analysis of the data and perform statistical analysis of the data, as appropriate, in order to assist the client in establishing product expiry/shelf-life.
At the end of each study, Blue Stream will issue a QA Audited Stability Program Final Report.
Please contact Blue Stream to further discuss our Stability Program Management options.