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 pharmaceuticals, biologics 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 authorities.

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.