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Process validation: Pre-requisites for Process Validation

 Process validation:

Process validation is the means of ensuringand providing documentary evidence thatprocesses (within their specified design parameters) are capable of repeatedly andreliably producing a finished product of therequired quality. 
According to the US Food and Drug Administration (FDA) – “Process validation is establishing documented evidence which provides a high degree of assurance that a specific process (such as manufacture of pharmaceutical dosage form) will consistently produce a product meeting its predetermined specifications and quality characteristics.”


Pre-requisites for Process Validation:

ü  Before process validation can be started, the following things must be qualified:-
-        manufacturing equipment 
-        control instruments 
-        formulation
ü  The information on apharmaceutical product should be studied indetail and qualified at the developmentstage, i.e., before an application formarketing authorization is submitted. 
ü  This involves studies 
-        on the compatibility of activeingredients and recipients
-        final drugproduct and packaging materials
-        stability studies
ü  Other aspects of manufacturemust be validated including critical services(water, air, nitrogen, power supply, etc.) andsupporting operations such as equipmentcleaning and sanitation of premises. 
ü  Propertraining and motivation of personnel are prerequisitesto successful validation. 

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