Stability studies-Regulatory evaluation & most frequently observed deficiencies-FDB experience Mercy...
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Transcript of Stability studies-Regulatory evaluation & most frequently observed deficiencies-FDB experience Mercy...
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
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