Across the pharmaceutical
and medical device
industry, regulations are in place to protect patients, as well as the well-being of those administering medical care to patients. There are many global organizations and regulators that have recommendations for the execution of extractables and leachables (E&L) testing programs
, including FDA, BPOG, EMEA, ISO
, USP, ASTM
and Ph. Eur.
In the article below, our experts share which standards related to E&L testing you need to focus on, and how a considered approach to E&L testing will help to get new medical devices and pharmaceutical products to market efficiently.
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