Do you have a disaster recovery plan to cover a chamber breakdown or emergency failure in your stability storage process? What happens when unforeseen events interrupt your stability study? The loss of samples that have been in stability storage due to a chamber breakdown or emergency in your sample storage process could represent a critical … Continued
Definitions Reference samples are retained to fulfil two purposes; firstly to provide a sample for analytical testing and secondly to provide a specimen of the fully finished product. They serve as a record of the batch of finished product or starting material and can be assessed in the event of, for example, a dosage form … Continued
We have recently increased the capacity of our facility at Q1 Scientific, with the introduction of Stability Rooms #30 and #31.
Development phase Accelerated stability tests provide a means of comparing alternative formula-dons, packaging materials, and/or manufacturing processes in short-term experiments. As soon as the final formulation and manufacturing process have been established, the manufacturer carries out a series of accelerated stability tests which will enable the stability of the drug product or medical device to … Continued