Stability Studies 2017-08-24T07:43:06+00:00

STABILITY STUDIES

  • PYRAMID understands the importance of accuracy, integrity, timeliness and compliance for all stability study programs.
  • PYRAMID’s stability services are proven reliable for pilot formulations, clinical batches and marketed products.
  • PYRAMID’s controlled storage area accommodates all ICH storage conditions. Each chamber operates independently with its own temperature, and where required, humidity controls. All chambers are monitored continuously 24 hours a day, 365 days a year and all recording and calibration devices are routinely calibrated to ensure their accuracy and performance.
  • PYRAMID can assist you in the design and set-up for your upcoming stability study including the development of protocols or study guidelines according to industry standards or client specified requirements, as applicable.
  • PYRAMID offers controlled stability storage and testing for long term and accelerated stability study projects under a variety of temperature and humidity conditions. We can also develop and/or validate a stability indicating method for your specific project.
  • Our stability study program includes documented protocols for the proper handling, storage and retrieval of all stability study materials.
  • Our record-keeping practices include internal custody procedures for all materials to ensure proper handling, storage and disposition are within the applicable regulatory guidelines. Each stability study is thoroughly documented upon receipt and includes details regarding the test schedule, parameters, storage conditions, specifications, etc., and fully conforms to the applicable cGMP requirements.
  • A master stability study schedule includes all test dates, requirements and conditions throughout the duration of the stability study and ensures all information is accurately logged, scheduled and tracked.