Category: US FDA Guidelines
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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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Clean room classification In Pharmaceutical Industry Guidelines
Clean Room Classification in pharmaceutical Industry how it is done?. What is a clean room and clean room Classification in Pharmaceutical Manufacturing? Which are the different requirements of clean room class in pharmaceutical manufacturing ? Relation of Particle count and Viable Count requirements of different grades of Clean Rooms. Clean rooms in pharmaceutical industry are…
Guidelines on Pharmaceutical Manufacturing Pharma Quality Assurance Quality Management System 