Quality Assurance and Regulatory Compliance for Pharmaceutical Product资料.ppt

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2018-05-28 发布于湖北
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Quality Assurance and Regulatory Compliance for Pharmaceutical Product资料.ppt

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Quality Assurance and Regulatory Compliance for Pharmaceutical Product资料

* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * Quality Assurance: Common Regulatory Compliance Issues Analytical methods Analytical methods not validated Analytical methods not stability indicating (for stability studies) Forced degradation studies not performed Inadequate justification for choice / selection of method (UV vs HPLC) Inadequate justification for selection of conditions (column, wavelength, run time, mobile phase, flow rate, temperature etc.) Non availability of method development report In adequate method validation parameters (e.g.: LOD, LOQ in RS method) 04th Oct. 2011 * M Quality Assurance: Common Regulatory Compliance Issues Stability Study Inadequate batch size (e.g.: less than 100,000 units or 1/10th of the commercial batch size whichever is higher) Inadequate number of batches (e.g.: minimum 1 batch for US, 2 batches for Europe etc.) Chamber temperature and humidity condition not appropriate to the target market (e.g.: Zone I II and Zone III and Zone IV conditions are different) Inadequate data at the time of submission (e.g.: 3 months data for US, 6 months data for Europe) 04th Oct. 2011 * M Quality Assurance: Common Regulatory Compliance Issues Stability Study Photo stability study not considered Improper container orientation (specially for liquid products) Inadequate stability study on bulk shipment pack (if intended to ship it for repackaging) Inadequate parameters covered under stability protocol (e.g.: microbial testing) Not charging samples under fall back condition 04th Oct. 2011 * M Stability Global climatic zones ? Zone Mean Kinetic Temperature (oC) Yearly average RH (%) Zone I (Moderate) 21 45 Zone II (Mediterranean) 25 60 Zone III (Hot Dry) 30 35 Zone IV (Hot humid) 30 70 04th Oct. 2011 * Stability Distribution of nations into different climatic zones:? Region Zones I II Zone III IV European All countries - American Chile, Canada, United States Brazil, Jamaica, Venezuela Asian China, Japan,