In Pharmaceutical Industries, analytical instruments are routinely used to assess that a certain product meets the required specification to guarantee quality and safety. In the US Pharmacopoeia, the general chapter USP <1058> describes the guidelines for the analytical instruments qualification (AIQ) to ensure that all the instruments are able to generate reliable and consistent data. The AIQ process involves interconnected activities over the lifetime of the instrument to establish fitness of purpose.
In this application note, the Operational Qualification of the PerkinElmer Lambda 365+ UV/Vis Spectrophotometer is carried out and demonstrated.