CORE OBJECTIVES OF ELSIE
- Advance principles of Quality by Design by enhancing the prospects for identifying potential safety issues at the initial stages of the development process, when container-closure materials are being screened and selected.
- Support member companies’ regulatory filings
- Reduce duplication of effort and minimize testing.
- Decrease the risk of substantial, unanticipated delays and associated costs.
THE NEED FOR AN EXTRACTABLES AND LEACHABLES DATABASE
Extractable and leachable
compounds from materials
used in container-closures for
and medical devices may be
toxic, carcinogenic, mutagenic,
teratogenic, or affect reproduction.
Assessing the safety of extractables
and leachables is an essential
element of the research and
development process. Detailed
assessments of these compounds
must be included in applications
submitted to health regulatory
Extensive extractables and
leachables safety data is publicly
available in peer-reviewed scientific
journals and government reports
and databases. This safety data
has never been incorporated into
a single comprehensive and readily
accessible database. Nor has there
been any industry-wide effort to
compile, organize, appraise and
summarize this data. Consequently,
each company must undertake
these efforts separately without
the benefit of the knowledge and
experience that could be gained
through collaboration with other
experts in industry and government,
and resulting in significant
duplication across companies.
If a safety issue related to
extractables or leachables is not
detected until the later stages of the
development process, a company
may experience substantial,
unanticipated delays in product
development, regulatory review,
and market introduction. These
delays could cost a company
millions of dollars in additional
development, lost market revenue,
and shortened patent exclusivity,
and could deprive patients of timely
access to their medications.
At the present time, industry and regulators have no central source of safety data on which to base decisions regarding the need for additional safety studies. Therefore, there is a risk that some such studies may be conducted unnecessarily.
The same or similar container closure
materials are used in many
different pharmaceuticals, biologics,
and medical devices. There is no
repository of extractables information
(e.g., controlled extractables data and chromatographic profiles, and study protocols) about these materials that could (i) provide a basis for screening and selecting materials for use in product development; and (ii) expedite further product-specific extraction and/or leachables studies.