There are many factors that go into an extractables and leachables risk assessment for the pharmaceutical market. For example, the larger and more frequent the doses are, the greater the risk a patient will be exposed to these risks. Whether the product is in solid or liquid form also factors into these assessments.

Boston Analytical’s leachables materials risk assessment process includes a risk assessment of all primary and secondary contact materials with the drug product. This can include both packaging and processing component materials. Vendor information is collected and reviewed to determine the leachables risk for each contact material. A test plan is devised that addresses the documented risk and ensures testing is not duplicated. This plan is appropriate for inclusion with regulatory filings to document the proactive, risk-based approach. This plan follows the direction of the FDA to use a Risk Based Approach to Extractables & Leachables testing.

Our comprehensive understanding of the regulations and requirements at play make us the ideal source for a USP <1663> assessment of extractables as well as USP <1644> for leachables.

We assist in evaluating the level of data collection and testing required to determine the risk assessment for extractables and leachables, with the goal of streamlining the process to avoid delays to market. Our team includes experts familiar with FDA review and approval. Boston Analytical provides support that assures patient safety and prompt product approval.

Risk Management Services