The presence of glass particles in ampoules is a critical quality concern in the manufacturing of injectable pharmaceutical products. Glass particles, even in minute quantities, pose serious risks to patient safety, including the potential for embolism, tissue irritation, or systemic inflammatory responses. Their occurrence compromises both the sterility and integrity of parenteral products, and as such, they are considered critical defects under regulatory guidelines.
This risk assessment is initiated in response to the observation of glass particulate matter during visual inspection of ampoules in a recent batch. The purpose of this assessment is to systematically evaluate the possible sources, severity, likelihood, and detectability of glass particle formation across the manufacturing lifecycle—from ampoule handling and sealing to inspection and packing.
The analysis considers key process inputs and variations using structured methodologies such as 6M analysis, FMEA, and FTA, in alignment with ICH Q9: Quality Risk Management and GMP principles. Contributing factors, including equipment performance, personnel practices, material quality, environmental conditions, and procedural compliance, are all taken into account.
Through this structured risk assessment, we aim to:
- Identify potential root causes of glass particle formation.
- Evaluate the impact on product quality and patient safety.
- Determine the effectiveness of current control measures.
- Recommend corrective and preventive actions (CAPA) to mitigate recurrence.
This document supports informed decision-making regarding batch disposition, regulatory reporting, and the implementation of robust quality controls to ensure product safety and compliance.