C. Iniya 1, A. Chenthilnathan1* and V. Vidyasagar2 1Department of Pharmaceutical Chemistry, Manonmaniam Sundaranar University, Tirunelveli–627 012, Tamil Nadu, India. 2Surien Pharmaceuticals (P) Ltd., Chennai–600 122, Tamil Nadu, India. Received: 8 May 2014, Accepted: 29 June 2014, Published Online: 18 July 2014
Process validation is the means of ensuring and providing documentary evidence that processes within their specified design parameters are capable of repeatedly and reliably producing a finished product of required quality. In this study, the process validation was carried out for the coated tablet dosage form which contains aspirin 75 mg. In tablet dosage form, critical parameters like drying, lubrication and compression were taken up for validation studies. In -process quality monitoring of all critical processing steps was done for three production batches. Assay after lubrication was within the specified limit, indicating blend uniformity. Physical parameters such as weight variation, Thickness, friability, disintegration time and assay were checked and results found within the acceptance criteria. During packing operation, blisters were checked and found satisfactory. Thus process validation of aspirin 75 mg in tablets was successfully completed and found within the specifications.
Keywords: Aspirin, Process validation, Coated tablet, Process parameters.