Stability studies-Regulatory evaluation & most frequently observed deficiencies-FDB

experienceMercy Acquaye

• Failure to provide summary/evaluation of stability data

• Failure to use requisite number of batches

• Failure to use requisite batch size

• Failure to test all stability-indicating quality parameters according to shelf life specifications of FPP

• Failure to provide details of the primary packaging materials

• Failure to provide the batch number of the API used for the FPP

• Failure to provide a detailed description of the container/closure system including any liner or wadding

• Failure to make reference to end of shelf life specification numbers containing the description of validated stability indicating methods

• Failure to report on the accuracy and precision of the analytical method

• Failure to include a report of validation of test for impurities and degradants

• Failure to provide stability protocol and stability testing commitment for on-going studies

• Failure to conduct studies at zone IVb climatic conditions of 30± 2oC and 75 ±5%RH

• Failure to submit adequate minimum long term and accelerated stability data to justify regulatory shelf life of FPP

Thank you