Abstract
Documented evidence with a high degree of certainty that a process will consistently produce product, meeting its predetermined quality attributes is said to be process validation. Here we have done the validation of critical steps during manufacturing such as blending, compression, coating and dissolution for our Galantamine hydro bromide tablets with the support of process validation protocol.
Selected 8mg Galantamine HBr tablets to be manufactured and divided in to sub batches which differ by bracketing, matrixing and the various loads were taken and various compression forces were used during compression of the tablets.
Finally we have monitored and recorded all the environmental conditions during every step of manufacturing for all the sub batches. Various parameters like premixing time, pre lubrication time, lubrication time during blending and the optimum machine speed followed during the compression of the tablets were recorded and we have checked whether the thickness and hardness for all the tablet sub batches and pan rpm, spray rate were within the limits as per BMR(Batch Manufacturing Record) during coating. Also we have compared the dissolution profile for all the sub batches (X, Y, Z) with the exhibit batch (E).
From the results we have found that temperature and RH were maintained well within the specified limits and there was no significant batch to batch variation and all the parameters studied were in accordance with BMR.
