Tag: USFDA Guideline
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What is 483 observation of USFDA
What is 483 USFDA observations? Detail information issued by the US FDAs 483 observation form. US FDA is world one of best pharmaceutical regulatory agency, when it conducts any inspection and observe any discrepancy or violation with respect to the good manufacturing practices guidelines issued by US FDA, it provides the observations in a format…
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Drug product stress testing forced degradation not required when stability test stability indicating
Drug product stress testing (forced degradation) is not necessarily always be conducted for the drug product when determining if a drug product stability test method is stability-indicating . What CGMPs requirements for this ? Answer given by US FDA for this question is as follows. (Forced degradation ) Drug product stress testing is not necessary…
Guidelines on Pharmaceutical Manufacturing Pharma Quality Assurance Quality Management System 