PerkinElmer expands LC/MS validation service
firms reduce the cost of regulatory compliance in pharmaceutical
drug development and manufacturing quality control laboratories.
This latest expansion to the firm's OneSource service means that PerkinElmer can now service, qualify and validate liquid chromatography/mass spectrometry (LC/MS) systems regardless of manufacturer. This is particularly important for LC/MS systems where customers may have bought the LC, MS and autosampler components from different manufacturers and while each of the components may be individually compliant the ensemble may fail. Various regulations are imposed on companies such that they must provide documented proof that results generated on laboratory equipment are valid from the start of the drug development process through to the quality control (QC) of released products. Failing to comply with regulations could lead to company's receiving a cautionary letter form a regulatory body such as the FDA (US Food and Drug Administration) to having to withdraw a product from the market. "There have been instances where the FDA has issued warning letters because companies have had a fragmented approach to how they qualify their equipment," said Paul Smith PerkinElmer's European Validation / Compliance Programme manager. This is where PerkinElmer really feel they can provide benefit to customers as rather than relying on different vendors to validate individual components who may interpret the regulations differently, they can validate the whole system in one go. "One of the benefits to having a multi-vendor approach is that you get a single document which is consistent in how it interprets guidelines and that it qualifies the components and the system as a whole," said smith. OneSource covers most technology platforms used in laboratories, such as GC (gas chromatography), LC, LC/MS, GC/MS, UV/Vis (ultra violet / visible) and IR (infrared) spectrometers as well as liquid handling robots. The compliance data can be seamlessly integrated into files and documents saving researchers time and effort and minimising the chances of costly errors. According to Andrew Attwood, Leader of PerkinElmer's Laboratory Services Business, the company offers a range of approaches depending on the circumstances of the customer, providing either 'off the shelf' protocols and documentation or a more personalised service to customers who require it. "A large organisation would look for standardisation and procedures across the whole of their instrument base and would be looking for someone to write bespoke protocols and a whole quality management system that pulls all the information together and interfaces it with their own documentation," said Attwood.