12 Feb 2015

Sharing pharmaceutical trace analysis knowledge with industry peers

Whitehouse, New Jersey, United States – Intertek, a leading quality solutions provider to industries worldwide, has been invited to instruct industry peers during Pittcon 2015, New Orleans, USA on “Trace Level Method Validation in the Pharmaceutical Industry - Practical Aspects of Method Validation”.  

Stringent requirements to minimize 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. In order 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” shares Dr. Gyorgy 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 (March 8th-12th) is the world’s largest annual conference and exposition for laboratory sciences. The technical program covers the latest research in more than 2,000 technical presentations covering a diverse selection of methodologies and applications.

Intertek has over 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.

Find out more:
Pittcon 2015 Short Course Program - Course Number:152
Date:Thursday, March 12, 2015 Start Time: 08:30 AM - 05:00 PM

Dr Lorna Kettle, Marketing Manager, Intertek Pharmaceutical Services
Tel.:+44 161 721 1476
Email: lorna.kettle@intertek.com

About Intertek
Intertek is a leading quality solutions provider to industries worldwide. From auditing and inspection, to testing, training, advisory, quality assurance and certification, Intertek adds value for its customers by helping improve the quality and safety of their products, assets and processes. With a network of more than 1,000 laboratories and offices and over 36,000 people in more than 100 countries, Intertek supports companies’ success in the global marketplace, by helping customers to meet end users’ expectations for safety, sustainability, performance, integrity and desirability in virtually any market worldwide. Visit www.intertek.com.  

Related Links
Pittcon - The importance of trace level testing and validation
Intertek Pharmaceutical Services (Whitehouse, NJ)
Extractables and Leachables Testing
GLP and cGMP Method Development, Validation and Remediation