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〈1661〉 Evaluation of Plastic Packaging Systems for Pharmaceutical Use and Their Materials of Construction

Drug products can chemically interact with their associated packaging systems and/or the system's plastic materials of construction while the drug product is being manufactured, shipped, stored, and administered. The magnitude of these interactions should not adversely affect the suitability of the packaged drug product, which includes both quality aspects and performance aspects such as efficacy, stability, purity, and compendial compliance.

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