Extractables & Leachables Regulatory Guidance Services

All regulatory bodies require extractables and leachables assessments and testing to be conducted according to the most current regulations and best practices. Element’s extractables and leachables regulatory guidance services help keep you up to date with changes in guidelines and industry requirements to ensure quality, safety, and efficacy.

New specifications are continually incorporated into the existing standards to ensure that medicines are appropriately manufactured, stored, distributed and dispensed. The ultimate goal is to guide the industry to effective and safe product development, hence protecting public health.

Our Engaged Experts carry out extractables and leachables (E&L) studies in compliance with regional guidance and regulatory specifications including Food and Drug Administration (FDA), United States Pharmacopeia (USP), and European Medicines Agency (EMA) requirements. We also follow best practice guidelines outlined by the Product Quality Research Institute (PQRI), BioPhorum Operations Group (BPOG) and Extractables and Leachables Safety Information Exchange (ELSIE). 

Extractables and leachables assessments 

We conduct E&L assessments to demonstrate product and material in accordance with new regulations and requirements; examples of new regulations are:

• <661> Containers – Plastics. The extractables and leachables testing is now a component of USP <661.2> Plastic Packaging Systems for Pharmaceutical Use
• General chapters for E&L testing
• USP <1663> Assessment of Extractbales Associated with Pharmaceutical Packaging/Delivery Systems
• USP <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging / Delivery Systems
• Extractables Testing for Plastic Manufacturing Equipment – USP <665>, formerly <661.3>
• PQRI best practices for parenteral and ophthalmic drug products – Final Recommendations Issued

Risk-based approach

When developing study plans for extractables and leachables testing, a “risk-based approach” is expected to be taken. Lower risk dosage forms, such as oral and topical drug products, typically do not require formal E&L testing for the packaging and manufacturing components if their materials of construction comply with the FDA food contact regulations. 

The Element advantage 

Element’s scientists are active participants in the working groups that have developed the current extractables and leachables best practices such as PQRI, USP Expert Panels, ELSIE, and BPOG. We know when actual E&L testing is expected and when an assessment report will be sufficient to meet the regulatory guidelines, so when testing is required, we can design efficient, customized protocols to meet your needs. 

For more information about our extractables and leachables regulatory guidance services or to request a quote, contact us today.