Regulatory considerations: E&L testing to ensure compliance

Regulatory considerations: E&L testing to ensure compliance

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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Smithers-What-Regulatory-Considerations-Do-You-Need-to-Ensure-Compliance

Download the article:

Smithers-What-Regulatory-Considerations-Do-You-Need-to-Ensure-Compliance

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