Abstract:
The purpose of research was to study retrospective and concurrent process validation
of Aluminium hydroxide, magnesium hydroxide and simethicones oral suspension.
Three initial process validation batches of same size, method, equipment and
validation criteria were taken. The critical parameters involved in mixing, pH,
Viscosity and filling were identified and evaluated as per validation master plan. All
the instruments were calibrated as per standard operating procedures. The outcome
indicated that data obtained by process validation of three batches provides high
degree of assurance that manufacturing process of Aluminium hydroxide, magnesium
hydroxide & simethicone oral suspension produces product meeting its
predetermined specifications and quality attributes. As well as retrospective validation
is done for 20 batches, each batch result was find as per specification and based on
this Annul product review(APR) was prepared.
