AstraZeneca on regulatory uncertainty and its potential impact

Ahead of his presentation at this November's Extractables and Leachables Europe. we spoke to Andrew Teasdale, Senior Principal Scientist at AstraZeneca, to discuss regulatory uncertainty, its potential impact, industry influences, future opportunities and more.

Q1. You will be discussing 'Regulatory uncertainty and its potential impact' this November, could you give us a sneak peek?

Unlike other major impurity classes i.e. mutagenic impurities, elemental impurities, solvents etc. there are no internationally agreed guidelines covering requirements for E&Ls.  Instead we have a plethora of regional guidelines, industry consortia papers i.e. PQRI ONIDP guidance and a number of other relevant documents e.g. Pharmacopoeial monographs .  The challenge is how to piece this together to deliver a compliant risk assessment.  The presentation will examine this challenge and look, through example, at the issues that arise from this uncertainty.

Q2. What changes have you seen in the E&L market in the last 5 years and how does that influence your current strategy? 

We have certainly seen wider regulatory scrutiny relating to E&Ls both in respect to container closure systems and materials used in the manufacturing process.

Q3. Where do you foresee the industry headed in the next 5 years and why?

Ultimately in my view there is a need for clear coherent guidance, ideally driven through adoption as an ICH topic.

Q4. What are you most looking forward to at E&L Europe 2018? 

The opportunity to network with experts in the field and to understand and discuss their challenges and hear their insights.

Andrew will be presenting as part of the Regulatory Landscape, Standards and Impact session at E&L Europe this November. Other presenters in the session include MHRA, US FDA, and Eakins and Associates


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