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.