Accountability

The Head of Creams Manufacturing is accountable for ensuring that this SOP is followed during the formulation process. Compliance with the cross-verification procedures is ultimately the responsibility of the Quality Assurance (QA) Manager.

5. Procedure

5.1 Preparation for Cross-Verification

1. Before starting the weighing process, ensure that the weighing equipment (e.g., balance, scale) is calibrated and clean. Confirm that the equipment is functioning correctly and is suitable for the materials being weighed.
2. Review the formulation recipe to confirm the required quantities of each material to be weighed. Check that all materials are available and labeled correctly.
3. Prepare the weighing area by ensuring it is free from contamination. All containers and utensils used for weighing should be clean and ready for use.

5.2 Weighing of Materials

1. Weigh the raw materials according to the formulation recipe. Ensure that the amounts of each material are measured precisely and are consistent with the recipe specifications.
2. Record the weight of each material in the Weighing Log, noting the batch number, material name, and the weight measured.
3. Once the materials are weighed, transfer them to a designated container for use in the cream formulation process. If there are any discrepancies in the weight, stop the process and consult the Quality Control team for further instructions.

5.3 Cross-Verification of Weighed Materials

1. The QC team will cross-verify the weight of each material before it is used in the formulation process. This involves comparing the weighed amount to the quantity specified in the formulation recipe.
2. If the weighed material does not match the required weight (within an acceptable tolerance), the QC team will initiate a re-weighing of the material and adjust the formulation quantities accordingly.
3. The QC team should also verify that the correct material has been weighed by matching the batch number and material name to the formulation recipe and the Material Identification Log.

5.4 Handling Discrepancies

1. In the event of discrepancies in the weight or material, the following actions must be taken:
   • Stop the formulation process immediately.
   • Report the discrepancy to the QA team.
   • Re-weigh the material to ensure the correct quantity.
   • Document the discrepancy in the Weighing Log, including the reason for the discrepancy, the corrective action taken, and the final verified weight.
2. If the error is due to a miscalculation or an equipment malfunction, the root cause should be investigated and corrective actions implemented to prevent future occurrences.

5.5 Documentation and Record-Keeping

1. All weighing activities, including cross-verification, must be documented in the Weighing Log. This log should include the material name, batch number, measured weight, verified weight, the names of the personnel involved in the weighing and verification process, and the time and date of each activity.
2. The Weighing Log should be reviewed by the QA team to ensure all records are complete and accurate. Any discrepancies should be flagged for investigation.
3. All records should be stored in accordance with GMP requirements and be available for audit by regulatory bodies or internal reviewers.

5.6 Final Review and Approval

1. After the cross-verification of all weighed materials, the QC team will provide a final review of the weighed quantities to ensure that they comply with the formulation requirements.
2. Once the cross-verification process is complete and no discrepancies are found, the materials are approved for use in the cream formulation process.
3. The QA team will document the approval of the materials and ensure that all required documentation is complete and accurate before the next stage of production begins.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• PO: Purchase Order
• GMP: Good Manufacturing Practices

7. Documents

1. Weighing Log (Annexure-1)
2. Weighing Verification Form (Annexure-2)

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 Weighing 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: Weighing Log

Material Name	Batch Number	Weighed Quantity	Verified Quantity	Verified By	Date
Active Ingredient X	12345	500g	500g	John Doe	10/03/2025
Excipient Y	67890	300g	300g	Jane Smith	10/03/2025

Annexure-2: Weighing Verification Form

Material Name	Batch Number	Weighed By	Verified By	Verification Date	Remarks
Active Ingredient X	12345	John Doe	Jane Smith	10/03/2025	No Issues
Excipient Y	67890	Jane Smith	John Doe	10/03/2025	No Issues

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