A typical pharmaceutical or biopharma production site utilizes scales and balances from material dispensing through quality control to packaging. This Performance Verification Checklist provides an overview of the relevant aspects that can help you implement a compliant and efficient quality management plan.
Download the checklist to discover how to:
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The legally mandated periodic performance verification of each weighing instrument not only requires significant resources but is also a source of possible compliance issues that might surface during an audit.
Having a set plan in place along with a calendar of when to perform specific checks can help ensure a successful audit and keep product quality consistent at all times. The Checklist is an excellent starting point to develop your plan.
Much like defensive driving, a risk-based approach is designed to consider every possible risk from the beginning to the end of a process. This ensures that preventative actions are put in place before they are even needed, proactively preventing problems before they occur.
Based on the determined risk level, an appropriate interval for calibration and testing activities can be established. Facilities producing products where tight levels of accuracy are critical are at a higher risk and, thus, should test more often. If weighing accuracy is less likely to affect final product quality, less risk is associated, and testing intervals can be further apart.
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Calibration is performed when a scale's current performance is measuring outside of the allowed tolerance for its purpose. A qualified technician performs the calibration using certified calibrated test weights constructed from a suitable material for the environment. Routine tests or functional tests are conducted in addition to regular calibrations to verify the performance of the weighing equipment at more frequent intervals, depending on the risk assessment of the weighing process. The equipment operator usually conducts routine tests with calibrated and certified test weights.
Depending on the risk assessment, define the required calibration intervals to ensure accurate measurements over time. Typical calibration schedules go from once per year to four times a year for higher risk weighing processes.
When your weighing risk is higher, routine tests help verify measurement performance in-between calibration intervals. The higher the weighing risk, the more routine tests should be scheduled. Testing should be increased in environments of rough handling, frequent temperature changes, or when production material can impact the scale’s performance.
