My company just acquire a VEEGO digital dissolution apparatus and ofcourse the DQ, IQ and OQ documents came with the equipment. But now , I need to do the performance qualification and/or process validation. What are parameters to consider in the exercise? Will really appreciate contributions from the well experienced experts in this our great forum. Thanks in advance.
These are 2 separate issues. Performance Qualification (PQ) is demonstrating that your dissolution apparatus is compliant with the USP sections on dissolution (like <1092>). Process Validation (PV) is performed for each product made by your process to demonstrate you are not making ‘concrete’.