Sharing pharmaceutical trace analysis knowledge with industry peers
Intertek, a leading quality solutions provider to industries worldwide, has been invited to instruct industry peers during Pittcon 2015, New Orleans, US, on 'Trace Level Method Validation in the Pharmaceutical Industry - Practical Aspects of Method Validation'.
Stringent requirements to minimise risks to patient health posed by harmful substances in medicines, driven by regulatory developments and product recall incidents, have spurred the need to reach ever lower detection limits for impurities. To detect trace levels of impurities, highly specific and sensitive analytical approaches must be applied by trained analytical scientists, coupled with flawless performance of the analytical instruments.
Dr Gyorgy Vas, Intertek’s thought leader on trace analysis has been invited as lead instructor to train industry peers as part of the short courses program at Pittcon 2015 on this topic. The course will cover instrument performance and qualification, sample preparation techniques, method validation and a summary of relevant guidance documents.
'A strategic approach to trace analysis can help achieve extremely low levels of detection in pharmaceutical applications, for example, determining if any potentially harmful substances migrate from packaging into the drug product,' says Dr Vas. 'These studies, known as “extractables and leachables”, require highly sensitive analytical methods.'
Chetan Parmar, Senior Vice President of Intertek Life Sciences, said: 'We are proud that our scientists have been invited to share their analytical science knowledge at such an important forum as Pittcon 2015. Their globally recognised knowledge benefits our clients on a daily basis.'
Pittcon, which takes place of 8-12 March, is the world’s largest annual conference and exposition for laboratory sciences. The technical programme covers the latest research in more than 2,000 technical presentations encompassing a diverse selection of methodologies and applications.
Intertek has more than 20 years’ experience in conducting Good Manufacturing Practice (GMP) compliant analytical studies supporting pharmaceutical development, including quantitative analysis for trace metals and trace organic substances, pharmaceutical active ingredient (API) analysis, stability studies and extractables and leachables studies.