Impact on industry practice from consortia dealing with container closure safety (E&L)

23 November 2011

 

In light of a remarkable landscape of consortia dealing with container closure safety (E&L), what impact have these consortia had with respect to current industry practice? Thomas Egert, Boehringer Ingelheim Pharma explains...

 

Since the first guidance for safety qualification of container closure systems (E&L) were issued by the US FDA, the scientific community has covered a considerable part of the road towards greater transparency and to a situation with more straight-forward and efficient strategies to address the issue. I consider those days when expectations had been apparent but not clearly specified as the most challenging periods. In an industry development team it often takes remarkable resources to arrive at an appropriate approach when guidance on how to move forward as well a clear picture of regulatory agency expectations are lacking.

Meanwhile significant publication, both with scientific and regulatory focus accompanied by recommendations from working groups, have generated some sort of a toolbox to be employed for a c/cs safety qualification exercise. This means such a project can be designed on sound scientific principles and decision points. Nevertheless and most importantly, these principles can be considered as widely acknowledged by regulators.

Moving forward and considering the main stakeholders in an E&L qualification exercise, I see a number of trends.
In the material sourcing process, suppliers often demonstrate considerable awareness and knowledge in the field while their behaviour towards proactive support increase. In chemistry (analytics) and toxicology, dedicated databases are evolving and will become accessible for the scientific community. As leachables represent an enormous but coincidentally specific and recurrent universe of chemical entities, it is obvious that substantial benefit is attained when this information can be made accessible in a structured and searchable manner. As the credibility of such data is mandatory, I consider initiatives like ELSIE (Extractables and Leachables Safety Information Exchange) of substantial value.

As far as the future of the regulatory landscape is concerned we might see a situation of more stringent and binding rules as, for example, current best practices and thresholds might find their way into compendial standards.

Extractables and Leachables 2011 will provide a perfect platform for representatives from industry, working groups and agencies to meet and to exchange information about the current industry situation and - needs. Such feedback is undoubtedly of high value, not only for the outcome of various consortia activities.

Thomas Egert, Chemical Characterisation, Drug Delivery Department, Boehringer Ingelheim Pharma will be co-chairing Extractables & Leachables 2011. He will also be providing an update at the conference on the status of PQRI PODP efforts to develop best demonstrated practices for extractables testing and toxicological assessment.

Find out more on his presentation and other topics being discussed at E&L 2011 from the full agenda. You can also view full details on all speakers here.

To hear further insight on extractables and leachables from Thomas Egert and many other industry leading experts register here for the conference.