Category: Validation

Clean Room Validation Recovery test

How a recovery test is done during validation of AHU/clean room in pharmaceutical manufacturing? Recovery test in AHU or clean room validation is a test where the ability of the clean room or AHU to maintain the level of cleanliness or the particle count below the rated classification limit. In the process clean room is […]

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Clean Room Validation Microbial Count Limits

Microbial action limits for clean room

Clean Room Validation Microbial Count Limits method settle plate contact plate viable bacterial fungal count limits frequency of validation. Classification of clean rooms in pharmaceutical manufacturing companies is part of validation activity, a clean room is designed to provide the desired level of clean grade environment. but it’s rated only to a particular grade after […]

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Revalidation in pharmaceutical manufacturing when why to do Revalidation

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Revalidation in pharmaceutical manufacturing its regulatory and general requirements. Validation in pharmaceutical is not only mandatory by law or regulation, but also it a is one of the method by which pharmaceutical quality assurance ensure that the drug manufactured in the firm will always meet the required quality standards. Validation is a process of collecting […]

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Validation in Pharmaceutical Industry Types of Pharma Validation

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Pharma Research Update

Pharmaceutical validation In pharmaceutical manufacturing industry Pharma Validation regulatory requirements. Validation in Pharma Industry is very important part of Pharmaceutical Quality Management System which in turn constitute quality assurance systems and intern Good manufacturing Practice guidelines. US FDA have given special emphasis on validation and it is prime requirement of US FDA pre-qualification, as well […]

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Validation Master Plan

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What is the Validation Master Plan Definition of Validation Master Plan? Why is the validation master plan important in the Pharmaceutical Manufacturing Industry? Is it made mandatory by US FDA to make A Validation Master Plan ? No it’s not Mandatory by USFDA Guidelines. Is Validation Master Plan document Mandatory as per WHO Guidelines ?  […]

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