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Identification and Risk-Assessment of Extractables and Leachables
- Article from:
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Pharmaceutical Technology
- Article date:
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January 1, 2006
- Author:
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Copyright informationCopyright Advanstar Communications, Inc. 2006. Provided by ProQuest LLC. (Hide copyright information)
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Extractable and leachable issues should be resolved early in the drug manufacturing process. Open communication is imperative for a successful study.
Drug manufacturers invest a tremendous amount of time and money to identify, quantify, and minimize impurities related to their drug products so that the US Food and Drug Administration can make informed decisions regarding drug product purity and safety. An area of increasing concern and scrutiny for FDA's Center for Drug Evaluation and Research (CDER) is the potential adulteration of drug products by extractable and leachable compounds that enter a drug from a container, closure system, disposable, or device.
Addressing this concern, 21 CFR ...