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Pharmaceutical Manufacturing and Packing Sourcer

Testing for 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 to meet 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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Frances L DeGrazio has been with West since 1983. Throughout her tenure she has served in various roles with the analytical laboratory and research and development areas. She is a member of the Parenteral Drug Association (PDA), American Chemical Society (ACS) and the American Association of Pharmaceutical Scientists (AAPS). Fran holds a BS degree in Chemistry from Cabrini College in Radnor, Pennsylvania, US.
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Frances L DeGrazio
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