Extractables and Leachables Studies

Regulatory agency expectations are continually evolving with ever more stringent requirements for the evaluation of drug product packaging associated with each new product. Our extractables and leachables scientists based at our GMPscientists conduct E&L analysis studies in accordance with regional guidance and nationally/internationally recognized standards including Good Manufacturing Practice (GMP), Product Quality Research Institute - PQRI extractables and leachables guidelines, United States Pharmacopeia (USP) requirements (e.g. USP extractable and leachable USP chapters <665>, <1665>, <1663>, <1664>, and <1664.1>), European Medicines Agency (extractables and leachables EMA guidance), US Food and Drug Administration, FDA extractables and leachables guidance, the BioPhorum/ BPOG Guidance, and ISO 10993-18 extractables and leachables guidelines (Part 18).

E&L Strategies

As an initial step, we aim to gather all information about your packaging system in order to build a robust picture of potential sources of leachables. The combination of our experience in method development for a controlled extractables study, coupled with our vast knowledge of leachable compounds and guidelines, means that we can anticipate and identify potential sources of risk associated with leachable impurities through strategic screening studies.
Typical study types include extractables assessment of container closure systems and packaging components, leachables evaluations of drug products from stability testing, and leachables evaluations of manufacturing surfaces or single-use processing materials /bioprocessing equipment.

We provide leachables method validation compliant to Good Manufacturing Practice (GMP) for use in GMP stability testing and storage programs and can support a wide range of closure or drug delivery systems such as pre-filled syringes, large volume parenteral products, orally inhaled and nasal drug products (OINDP), single-use and disposable medical equipment, printed packaging or secondary packaging migration behavior (labels, inks and dyes). Leachables associated with medical devices (ISO10993-18), drug delivery systems, implantable medical devices and other devices such as e-cigarettes are also assessed.

https://www.intertek.com/pharmaceutical/analysis/extractables-leachables/