Personnel: Ensures that materials are stored properly and accessible for accurate dispensing, and verifies the materials are not expired before use.

4. Accountability

The Head of Creams Manufacturing is responsible for ensuring that the procedure for handling dispensing discrepancies is followed correctly. The QA Manager is responsible for ensuring that discrepancies are addressed, and corrective actions are implemented in compliance with this SOP.

5. Procedure

5.1 Identification of Discrepancies in Dispensing Weights

1. Discrepancies in dispensing weights may be identified by production personnel during the weighing process, or they may be noticed during post-dispensing checks by QC personnel.
2. If the weight of the dispensed material deviates by more than ±2% from the prescribed amount in the formulation, it should be considered a discrepancy and reported immediately.
3. Discrepancies can occur due to various factors, such as equipment malfunctions, incorrect calibration, or human error. All discrepancies must be documented, including the material name, batch number, and the deviation noted.

5.2 Reporting Discrepancies

1. Production personnel must immediately report any weight discrepancies to the QA team using the Material Discrepancy Report. This report should include details such as:
   • Material name and batch number
   • Actual weight dispensed
   • Expected weight as per formulation
   • The cause, if known
   • Person responsible for the dispensing
2. The QA team will assess the reported discrepancy and determine if it requires immediate corrective action or if it can be addressed in a subsequent review.

5.3 Investigating Discrepancies

1. Once a discrepancy is reported, the QA team will investigate the cause of the deviation. The investigation will include:
   • Reviewing the calibration of dispensing equipment
   • Assessing the materials for any issues (e.g., moisture content affecting weight)
   • Interviewing personnel involved in the dispensing process to identify any procedural issues
2. Based on the investigation, the QA team will determine if the discrepancy is a result of equipment malfunction, human error, or material issues. This will guide the corrective action plan.

5.4 Corrective Actions

1. If the discrepancy is determined to be within the acceptable limits (±2%), the material can be used for the batch, but it must be clearly noted in the Material Dispensing Log and reviewed by QA.
2. If the discrepancy exceeds the acceptable limits (more than ±2%), the material must not be used in the batch, and the QA team must decide on the corrective actions. The material will be segregated, and a reweighing or resampling may be required.
3. The corrective actions could include re-calibrating equipment, retraining personnel, or reviewing and updating procedures to prevent future discrepancies.
4. Once corrective actions are implemented, a Corrective Action Report should be completed, outlining the cause of the discrepancy, the actions taken, and the steps to prevent recurrence.

5.5 Documentation

1. All discrepancies, investigations, and corrective actions must be documented in the Material Discrepancy Report and the Corrective Action Report.
2. The Material Dispensing Log should be updated to reflect any changes or adjustments made to the dispensed quantity, as well as the final decision on whether the material was accepted or discarded.
3. Ensure that all documentation is reviewed and signed off by the QA team to confirm that all discrepancies have been addressed and that corrective actions are completed.

5.6 Post-Dispensing Checks

1. Once corrective actions are completed, perform a post-dispensing check to ensure that future discrepancies are minimized. This includes regular calibration of dispensing equipment and periodic training for all personnel involved in the dispensing process.
2. The effectiveness of the corrective actions should be monitored over time to ensure that no further discrepancies occur.

5.7 Final Approval

1. After addressing all discrepancies and implementing corrective actions, the batch can proceed to the next stage of production if the materials are within acceptable limits.
2. The QA team will provide the final approval for the batch to ensure compliance with all regulatory requirements and internal standards.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• GMP: Good Manufacturing Practices

7. Documents

1. Material Discrepancy Report (Annexure-1)
2. Corrective Action Report (Annexure-2)
3. Material Dispensing Log (Annexure-3)

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• Internal SOP for Material Handling and Dispensing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Material Discrepancy Report

Material Name	Batch Number	Discrepancy Description	Corrective Action Taken	Reported By	Resolution Date
Viscosity Modifier A	12345	Incorrect weight dispensed	Re-weighed, retrained staff	John Doe	20/05/2025

Annexure-2: Corrective Action Report

Deviation	Corrective Action Taken	Responsible Person	Completion Date
Incorrect Dispensing	Reviewed procedures, recalibrated scale	John Doe	21/05/2025

Annexure-3: Material Dispensing Log

Material Name	Batch Number	Quantity Dispensed	Dispensed By	Time/Date
Colorant B	12346	100g	John Doe	20/05/2025

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head