Major Audit Findings about Equipment and Instruments
Major Audit Findings about Equipment and Instruments in Pharmaceuticals
Equipment and instruments are critical for ensuring product quality, reliability of test results, and compliance with cGMP. Regulatory inspections (FDA, EMA, MHRA, WHO) often highlight deficiencies in this area. Common findings include:
1. Qualification & Validation Issues
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Lack of DQ/IQ/OQ/PQ documentation.
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Periodic requalification not performed.
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Validation reports missing scientific justification or acceptance criteria.
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Using unqualified equipment for production or testing.
2. Calibration Deficiencies
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Overdue or missed calibrations.
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Inadequate calibration frequency or scope.
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Use of equipment after calibration failure without documented impact assessment.
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Lack of traceability to national/international standards.
3. Preventive Maintenance Gaps
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Maintenance not performed as per schedule.
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Incomplete or missing maintenance records.
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Equipment breakdowns handled with temporary fixes instead of root cause-based repairs.
4. Poor Cleaning and Sanitation
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Inadequate cleaning procedures for shared equipment.
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Cross-contamination risks due to improper cleaning validation.
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Missing or incomplete cleaning logs.
5. Data Integrity Concerns (Instruments in QC Labs)
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Lack of proper audit trails in computerized systems (HPLC, GC, UV, balances).
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Shared login credentials instead of individual user IDs.
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Unauthorized software access allowing data deletion or modification.
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Failure to back up raw data properly.
6. Improper Equipment Use
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Instruments used outside validated ranges.
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No SOPs or outdated SOPs for operation.
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Operators not trained or qualified on the equipment.
7. Environmental & Utility Control
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Uncontrolled environmental conditions (temperature, humidity, pressure).
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Utilities (compressed air, purified water, HVAC) not monitored or qualified.
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No alarm or alert systems for critical equipment.
8. Documentation & Record-Keeping Issues
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Incomplete logbooks (missing entries, overwriting, backdating).
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Equipment usage not traceable to specific batches.
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Lack of status labeling (e.g., “calibrated,” “under maintenance,” “out of service”).
9. Spare Parts and Change Control
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Use of non-approved or non-qualified spare parts.
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Lack of change control for equipment modifications.
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No impact assessment on product quality after changes.
10. Safety and Compliance Risks
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Missing safety interlocks or alarms.
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Equipment operating with known defects.
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Inadequate risk assessments for new equipment.
✅ Key Takeaway:
Audit findings about equipment and instruments usually stem from weak qualification, poor maintenance, calibration lapses, inadequate documentation, and data integrity issues. Ensuring strict control over the equipment lifecycle is essential for GMP compliance.
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