QC Audit Checklist

1. General Documentation & Records

• SOPs for all QC activities (latest approved versions, controlled copies).

• Records of training, competency assessments, and analyst qualification.

• QC logbooks (instrument usage, calibration, maintenance).

• Change control records affecting QC methods or equipment.

• Data integrity compliance (audit trails, raw data storage, secure backups).

2. Sample Management

• Proper receipt, labeling, and storage of samples.

• Chain of custody documentation.

• Retention sample management and disposal procedures.

• Segregation of rejected and approved samples.

3. Testing & Methodology

• Approved test methods (validated/verified).

• System suitability and method performance checks.

• Handling of OOS, OOT, and deviations.

• Correct and consistent use of reference standards.

• Calibration of glassware and volumetric devices.

4. Instruments & Equipment

• Calibration schedules and certificates.

• Preventive maintenance records.

• Qualification documents (IQ, OQ, PQ).

• Cleaning and shutdown/startup procedures.

• Equipment logbooks updated and signed.

5. Reagents, Solvents & Mobile Phases

• Storage conditions (temperature, light protection).

• Expiry and requalification status.

• Labeling with preparation date, expiry, initials.

• Use of analytical-grade or specified quality solvents.

6. Laboratory Practices

• Compliance with safety procedures and PPE usage.

• Glassware cleaning SOPs followed.

• No cross-contamination between testing areas.

• Controlled environmental conditions (temperature, humidity).

• Waste disposal records and safety compliance.

7. Data Integrity & Reporting

• Original raw data preserved and accessible.

• No unauthorized changes in results.

• Electronic records with secure login and restricted access.

• Audit trails reviewed regularly.

• Proper review and approval by authorized personnel.

8. Stability Studies (if applicable)

• Approved stability protocols.

• Proper storage of stability chambers.

• Monitoring of environmental conditions.

• Stability data trending and review.