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The Importance of Leachables and Extractables Testing for a Successful Product Launch

The FDA guidance for industry, container closure systems for packaging human drugs and biologics addresses the review and evaluation of packaging requirements. According to this document, each new drug application (NDA) or abbreviated new drug application (ANDA) should contain enough information to demonstrate that a proposed container closure system and its components are suitable for its intended use. The type and extent of information required will depend on the dosage form and route of administration. Qualification and quality review is applied to packaging materials and to the actual dosage form. Packaging suitability is based on four attributes: protection, safety, compatibility and performance (function and/or drug delivery). For injectable dosage forms, the document outlines the tests required to show that interaction is not a problem. Associated components, such as those used only at the time a dosage is administered, self-adhesive labels and secondary packaging materials are also included in the review process.

Inhalation and injection drug products have the highest requirements. There are product-specific draft guidelines for metered dose inhalers (MDI), dry powder inhalers (DPI), nasal sprays and inhalation solutions, suspensions and spray drug products. The identity and concentration of leachables in inhalation and nasal drug products must be monitored throughout the dosage form's shelf life since the product consists of the dosage form and container closure system.


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By Frances DeGrazio, Vice President of Quality Assurance at West Pharmaceutical Services, Inc. Frances DeGrazio joined West Pharmaceutical Services in 1983 and has since held various positions of increasing responsibility in the field of elastomer technologies and analytical and customer technical support. In her current position as Vice President of Quality Assurance, Americas, she is responsible for quality assurance and quality control for nine manufacturing facilities and the core technology laboratories.
Frances is a member of the American Chemical Society, the American Association of Pharmaceutical Scientists, the Parenteral Drug Association, the Institute of Packaging Professionals, Women in Packaging, the Philadelphia Rubber Group, and the American Association of Pharmaceutical Scientists. She graduated Cum Laude with a BS in Chemistry from Cabrini College, Pennsylvania, in 1982.

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Frances DeGrazio
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