In the EMA newsletter published in September 2019, the pharma industry was given a wake-up call regarding the request to evaluate the risk of the presence of nitrosamine impurities in human medicinal products containing chemically synthesised active pharmaceutical ingredients. This presentation will look at case studies of analytical testing in the three-step request to review the risk for presence of nitrosamines in medicinal products process issued by EMA/FDA.
- Nitrosamine testing of packaging materials found ‘at risk’ and ‘Fill the gap’ testing to support the paper-based Risk evaluation/assessment
- Analytical challenges for Confirmatory testing
- Routine testing as part of changes to the marketing authorization
Ank Reumer– Senior Study Director, Quantitative Methods- Nelson Labs Europe
Bio: Ank Reumer received her Ph.D. from the Faculty of Sciences at the University of Leuven (Belgium). As a PostDoc at the Mass Spectrometry Facility of Leuven, she developed methods for peptide biomarker discovery. In 2014 she started working at Nelson Labs. Currently she is senior Study Director in the Quantitative methods team. The main focus points of this group are method development and validation for evaluation of leachables and nitrosamines in Drug Products, as well as in use stability testing of drug-medical device combinations and stability testing of Drug Products.
Andrew Teasdale, PhD– Senior Principal Scientist Impurities Management Astra Zeneca
Andrew Teasdale PhD has over 25 years’ experience in the pharmaceutical industry as an analytical chemist and within quality assurance and regulatory roles. In his current role he chairs AstraZeneca’s Impurity Advisory Group. Dr Teasdale has published a number of papers relating to extractables and leachables, mutagenic impurities and other impurity related matters. He is currently the chair of the Extractables and Leachables safety Information exchange (ELSIE) and also led a number of industry expert groups; these include both safety and quality groups within Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), Product Quality Research Institute (PQRI) . Andrew has also represented EFPIA in ICH Q3C, Q3D and Q3E Expert working groups. He has also advanced a number of key scientific advancements in the control of impurities as the inventor of the purge factor concept and the instigator of the development of Elemental Impurities database for excipients. With over 50 scientific papers, he has also written 2 books:
Genotoxic Impurities – Strategies for Identification and control. Editor A Teasdale. Publisher Wiley. ISBN 978-0-470-49919-1
ICH Quality Guidelines – An Implementation Guide. Editors A Teasdale, D Elder, R W Nims. Publisher Wiley. ISBN 978-1-118-97111-6.