GMP Audit Checklist – Weighing & Dispensing

1. Area & Environment

• Weighing/dispensing area dedicated, controlled, and clearly labeled.

• Differential pressure maintained between adjacent areas.

• Environmental conditions (temperature, humidity, cleanliness) monitored.

• Cleanliness of area maintained before and after each activity.

• Access restricted to authorized personnel.

2. Equipment & Balances

• Balances calibrated and within valid calibration period.

• Balance verification performed daily/ before use.

• Equipment cleaned before and after use; cleaning records maintained.

• Use of dedicated scoops, spatulas, and containers.

• Equipment ID labels available (Cleaned/In-use/To be cleaned).

3. Materials

• Raw materials received with proper status labels (Quarantine/Approved/Rejected).

• Materials transferred to dispensing area with proper authorization.

• Containers properly cleaned, intact, and sealed before dispensing.

• Materials stored under defined conditions.

• Material identification verified against batch manufacturing record (BMR).

4. Dispensing Process

• Dispensing performed as per approved SOP and BMR.

• Personnel trained and qualified for weighing/dispensing activity.

• Two-person verification followed (one performs, one checks).

• Line clearance obtained before starting dispensing.

• Use of clean, labeled, and dedicated containers/bags for dispensed material.

• Cross-contamination controls in place (segregation, unidirectional flow).

5. Documentation

• Material requisition and dispensing records available.

• All weighing entries recorded in logbook/BMR with signatures.

• Corrections made as per ALCOA+ principles.

• Labels on dispensed material include:

  • Material name

  • Batch/lot number

  • Quantity dispensed

  • Date & signature of operator/checker

• Reconciliation performed for issued vs. dispensed quantities.

6. Controls & Compliance

• Use of barcode/RFID systems (if applicable) for traceability.

• SOPs available for weighing, dispensing, cleaning, and operation of balances.

• Deviations, OOS, or discrepancies reported and investigated.

• Access control for weighing area (e.g., airlocks, restricted entry).

• No expired/rejected materials present in the area.

7. Safety

• PPE worn by all personnel (gloves, masks, gowns, goggles).

• Dust extraction/containment system functioning properly.

• Spill control procedure in place.

• Material safety data sheets (MSDS) available in dispensing area.

✅ Key Audit Focus Points:

• Observe gowning and hygiene of personnel.

• Check calibration and use of balances.

• Verify reconciliation and traceability of dispensed material.

• Ensure segregation and contamination control during dispensing.

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