Pharamceutical Industry & Life Sciences










Importent Points in Pharama Industry:



Handling specification 
impurities
Trial Batch(RD & A R&D)
Critical Process Parameter
In Process
R&D ,A R&D  small scale batches
Design Qualification Area(Plant)



Process Validation : Critical Parameter,How Many Batches, Impurities,Yield,Quality.

Validation Protocol: Critical Process Parameter,Specification ,Yield,Quality, Equipment,

Revolidation: Process Major Changes ,Equipment Changes,Raw Material Changes.


Design Qulification, Installation Qualification,Operational Qualification,Performance Qualification Before three batch execution of manufactureing based on Customer.


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