Concurrent Process Validation of Ramipril Tablets

The prime objective of any pharmaceutical plant is to manufacture products of requisite quality at the lowest possible cost. Good manufacturing practices for pharmaceutical products require that critical processes, which may affect product quality, have to be validated. The rationale behind this is that if more effort is placed on development and validation at the beginning, then there will be no chance for failure during product life. The main objectives of process validation are to prove that the process is consistently undergoing what it is supposed to undergo which means that the process is under control and to determine the process variables and acceptable limits for these variables and to set up appropriate in-process controls. The application of a process validation program simply proves that the process step being evaluated reliably does what was expected of it. A successful process validation effort thus builds quality into the process so that the reliance on end product testing can be minimized. In the present study, concurrent process validation studies were carried out for Ramipril as per the Batch production record. The tablets were evaluated for various physiochemical parameters by official procedures. The invitro dissolution studies were carried out in 0.1 M HCl and the results were found to be 97%, 95% and 96% respectively for the three batches at the end of 45 minutes. The results for the assay were found to be within the acceptance criteria. From the validation studies carried out, it was observed that no modifications are required in the present manufacturing process. The method requires further validation only when there is change in raw materials or equipment or process.