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Area of Science:

  • Pharmaceutical Science
  • Quality Control
  • Risk Management

Background:

  • Visual inspection of pharmaceuticals is a long-standing compendial requirement.
  • Current methods categorize particles by size, source, and type.
  • Existing visible particle control strategies have seen limited advancement.

Purpose of the Study:

  • To propose a more risk- and science-based approach for evaluating visible particles in parenteral products.
  • To outline a method for determining the patient safety impact of these particles.
  • To enhance consistency in handling particle observations within pharmaceutical quality systems.

Main Methods:

  • Utilizing forensic data, toxicological/medical opinions, and prior knowledge.
  • Developing an outline for assessing patient safety impact.
  • Defining potential actions for lot disposition based on risk assessment.

Main Results:

  • A framework for evaluating visible particles based on scientific data and risk assessment.
  • Potential actions for quality systems regarding lot disposition.
  • Improved focus on patient safety risks associated with visible particles.

Conclusions:

  • A risk- and science-based approach offers a more robust method for visible particle evaluation.
  • This approach enhances the use of prior knowledge and improves consistency in quality systems.
  • Prioritizing patient safety impact is crucial for pharmaceutical quality control.