Stability studies-Regulatory evaluation & most frequently observed deficiencies-FDB experience Mercy 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± 2 o C and 75 ±5%RH Failure to submit adequate minimum long term and accelerated stability data to justify regulatory shelf life of FPP

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