Major Audit Findings about Equipment and Instruments
🔎 Major Audit Findings – Equipment & Instruments
1. Qualification & Validation Issues
-
Missing or incomplete DQ/IQ/OQ/PQ records.
-
Equipment used without initial or periodic requalification.
-
Validation protocols not followed or not approved before execution.
-
Failure to perform periodic performance verification.
2. Calibration Deficiencies
-
Instruments not calibrated as per schedule.
-
Calibration records missing or incomplete.
-
Use of equipment beyond calibration due date.
-
Lack of traceability to national/international standards.
-
No documentation of calibration failure investigations.
3. Maintenance & Preventive Maintenance
-
Preventive maintenance not performed or not documented.
-
Breakdown maintenance logs incomplete.
-
Use of equipment without confirming maintenance status.
-
Inadequate spare parts or service support leading to downtime risks.
4. Cleaning & Cross-contamination Control
-
Lack of validated cleaning procedures.
-
Residue limits not scientifically justified.
-
Equipment not properly labeled as Cleaned / In-Use / To Be Cleaned.
-
Dirty equipment left unattended in production areas.
-
Poorly maintained surfaces leading to contamination risks.
5. Data Integrity & Instrument Software
-
Lack of audit trails in analytical instruments (HPLC, GC, UV, etc.).
-
Shared logins or no user access control.
-
Manual overrides or undocumented adjustments in results.
-
Inadequate backup and data security controls.
-
Missing electronic records supporting reported results.
6. Equipment Identification & Labeling
-
Equipment not uniquely identified with ID numbers.
-
Missing status labels (e.g., “Calibrated,” “Out of Service”).
-
Use of obsolete or defective instruments.
7. Documentation Gaps
-
Incomplete equipment usage logs.
-
Missing entries for batch-related equipment usage.
-
Unapproved or uncontrolled logbooks.
-
Discrepancies between actual usage and records.
8. Environmental & Utility Systems
-
HVAC and cleanroom monitoring instruments not calibrated.
-
Inadequate monitoring of temperature, humidity, or differential pressure.
-
Compressed air/water systems not qualified.
-
Poorly maintained sensors and gauges.
9. Spare / Backup Instruments
-
Backup balances, pH meters, or HPLCs not calibrated but used.
-
Use of non-validated instruments during breakdowns.
10. Risk & Change Management
-
Equipment changes (replacement of parts, upgrades, relocation) not assessed for impact.
-
Lack of risk assessment before introducing new instruments.
🎓 Discover one of the best Complete Pharmaceutical Quality Assurance Course available —click below to explore the course that’s shaping future in QA Course skills.