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By Renée Bailey, BlackHägen Design | One of the most integral components in the development of drug-device combination products is the use-related risk analysis (URRA) and its applicability to the overall human factors engineering process. Deficiencies in the URRA are a leading cause of delays with FDA submissions. |
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| Your Approach To USP <382> For Your Drug Product Packaging | Article | West Pharmaceutical Services, Inc. | USP requirements for elastomeric components of container closure systems used for parenteral products are changing. Explore the implications for vial, syringe, and cartridge closure systems. |
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