A company recently received this 483 observation:
….. The written stability program for drug products does not include reliable, meaningful, and specific test methods.
Specifically, the stability program designed to assess the stability characteristics of drug product is deficient in that the stress studies do not assure the impurity methods can detect all unknown impurities. The stress study procedure, … “Guidelines for Validation and Transfer of Analytical Methods” states stress testing should be carried out on the sample matrix to demonstrate that the primary degradation products do not interfere with analytes of interest. The studies to not verify that all impurities generated by the stress studies can be detected by the method being run.
For more observations pertaining to lab controls, see our new issue 1060 available today. It also has observations pertaining to quality systems, manufacturing controls, and medical devices.
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