Extractables & Leachables in OINDP Testing Regulations

    Although there aren’t specific regulations stating that extractables & leachables testing must be carried out on any drug product, its importance is still noted by regulatory organizations. Most of the regulations defined today involve extractables & leachables testing in OINDP because these drug products carry the most risk. Process equipment, medical devices and medicinal products are each subject to different regulations for extractables & leachables testing.

    • Process Equipment Extractables & Leachables Testing Regulations: This area of extractables & leachables testing requires the assessment of the impurities and their toxicological effects, as well as assessing how suitable the container is in relation to the product it contains.
    • Medical Devices Extractables & Leachables Testing Regulations: Regulations state that manufacturers must consider the risks associated with product contamination to anyone involved with the device, the risk of substances leaking from the device, and the risks posed by the unintentional entrance of substances into the device.
    • Medicinal Product Extractables & Leachables Testing Regulations: It is recommended that drug manufacturers test for extractable materials in container closure systems for pharmaceutical preparations, and to assess any potential for these to interact with the product and become leachables within the product during product stability studies.

    There are many organizations that provide guidance documents on extractables & leachables testing, including:

    • Federal Drug Administration (FDA)
    • The European Agency for the Evaluation of Medical Products (EMEA)
    • International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use (ICH)
    • Product Quality Research Institute (PQRI)
    • Orally Inhaled and Nasal Drug Products (OINDP)
    • Parenteral and Ophthalmic Drug Products group (PODP)
    • Bio-Process Systems Alliance (BPSA)
    • International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS)
    • Parenteral Drug Association (PDA)
    • The Extractables and Leachables Safety Information Exchange (ELSIE)

    By employing a thorough extractables & leachables testing methodology, Smithers Rapra ensures that drug products manufactured by our clients will meet regulatory standards. Request a quote for our extractables & leachables testing in OINDP & PODp’s.