Category: US FDA Guidelines

Clean room classification In Pharmaceutical Industry Guidelines

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Clean Room Classification Pharma Industry

Clean Room Classification in pharmaceutical Industry how it is done?. What is a clean room in Pharmaceutical Manufacturing?. Which are the different requirements of clean room class in pharmaceutical manufacturing ? Particle count and Viable Count requirements of different grades of Clean Rooms. Clean rooms in pharmaceutical industry are classified by three Standards. 1. ISO […]

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USFDA Guidelines quality audits 21 CFR Sec.820.22 Medical devises

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USFDA in its guidelines on Quality System, it has mentioned guidelines regulations, means it’s mandatory for pharmaceutical manufacturing units to follow the Guidelines. US FDA guidelines on Quality audits mention that Pharma Manufacturer must have a Procedure for quality audits, these must ensure and establish that Quality systems are followed and are in state of […]

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