FDA Releases Guidance on Safety Considerations and Product Design

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The agency issues safety guidance to minimize medication errors relating to product design and container closure design.

FDA has issued guidance providing best practices and detailing a systems approach to minimize medication errors associated with product design and container closure design. The guidance applies broadly to drug development and is intended for investigational new drug applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs), abbreviated new drug applications (ANDAs), and over-the-counter monograph drugs. 

The guidance is the first in a series of guidance documents focused on minimizing medication errors and improving product safety. Included in the guidance are examples of product designs that have resulted in postmarketing errors. According to FDA, “many medication errors can be avoided at the design stage by drawing on lessons learned from past medication errors and by conducting proactive risk assessments before marketing.”

FDA states that CGMP concepts, such as corrective action and preventive action and risk management, can be applied to the overall design of a drug product to identify design features that could possible result in medication errors. The guidance states, “in order to identify and assess potential medication errors, the product designer must understand how the drug product will be used, including who will handle or use the product, the chronicity of use, the environments of use, and how the end users will interact with the drug product (e.g., the product, container closure, container label, and accompanying labeling).”

FDA recommends manufacturers consider the following throughout a product’s design and development:


  • End user and environments of use. There can be multiple end users with different levels in training across multiple environments of care, which could also include sub-environments. FDA suggests manufacturers “consider how the use of the product may differ in varying typical environments of use for the product under development.”

  • Drug product-user interface. “A well-designed user interface facilitates correct actions and prevents or discourages actions that could result in medication error.” FDA details points to consider for solid-dosage oral forms, tablet scoring, transdermal systems, product strength, intravenous products, and container closure design.

  • FDA also addresses proactive risk assessments such as failure mode and effects analysis and simulated use testing.

Additional guidance documents in this series will focus on risks associated with container and carton labeling and selecting proposed proprietary names. 

Source: FDA