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 safety 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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