AIQ, LEQ, and Methods Validation
Expertise to Perform Qualifications for a Variety of Instrument Classifications
Manufacturers come to ProPharma Group when they require a risk-based, quality assured, and compliant approach to conduct qualifications above and beyond traditional commissioning and qualification tasks. We specialize in a variety of different classifications of instruments, eliminating the need to involve third-party laboratories or vendors. The benefit? A savings in time and money, while ensuring your products meet specifications through all qualification phases.
Depending on the degree of complexity of the instrument, the analytical instrument qualification (AIQ) process may vary (qualification phases, design qualification, installation qualification [IQ], operational qualification [OQ], performance qualification [PQ]/user acceptance requirements). ProPharma Group performs the necessary PQ that, often times, instrument vendors cannot (or perhaps will not). We generate the PQ document and execute the document to confirm “fitness for purpose” based upon a risk assessment recommended by the United States Pharmacopeia Convention (USP).