Abstract

CONCURRENT PROCESS VALIDATION OF MAGNESIUM HYDROXIDE & ALUMINUM HYDROXIDE AS CHEWABLE TABLET

S. P. Salunke*, R. L. Shirole, R. D. Wagh, N. L. Shirole

ABSTRACT

The main aim of the present research work was to study Concurrent Process validation of Magnesium Hydroxide & Aluminum Hydroxide as Chewable tablet. Validation is best viewed as an impartment and integral part of cGMP. Validation is therefore one element of quality assurance programs associated with a particular process. Quality cannot be assured only by doing finished product testing and inprocess monitoring but it should be built into the manufacturing process. So building of quality require a special attention to a few factors like selection of material, process design, control variables, in process control and finished product testing. In this study three initial batch of Magnesium Hydroxide & Aluminum Hydroxide as Chewable tablet with same size, method, equipment & validation criteria were taken. Various critical parameters during dry mixing, wet granulation, drying, lubrication, and compression stages were identified and evaluated as per validation protocol. The outcomes of the entire process indicate that process validation data provides a high degree of assurance that the manufacturing process will produce a product meeting its predetermined specification and quality attributes.

Keywords: Concurrent Process validation, Magnesium Hydroxide & Aluminum Hydroxide, Chewable tablets.