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By Erica Tullo, Ph.D.

December 21, 2016

Pharmaceutical industry focus on issues of extractables and leachables from packaging/delivery systems began during the mid-1990’s. Since then, regulatory agencies have become more educated, and drug product formulations have become more complex, which makes the need for a robust extractables and leachables program that much more critical. Failure to properly evaluate extractables and leachables has had a negative impact on many pharmaceutical companies, e.g., late-stage stability failures, submission delays, and recalls. To avoid this, the question is – where to start?