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.
