SOP Guide for Pharma

Creams: SOP for Cross-Verification of Weighed Materials – V 2.0

Auditor

Creams: SOP for Cross-Verification of Weighed Materials – V 2.0

Standard Operating Procedure for Cross-Verification of Weighed Materials

Department Creams
SOP No. SOP/CRM/003/2025
Supersedes SOP/CRM/003/2022
Page No. Page 1 of 6
Issue Date 10/03/2025
Effective Date 15/03/2025
Review Date 10/03/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for the cross-verification of weighed materials during the cream formulation process. This ensures that the quantities of raw materials used in the formulation are accurate and comply with the specified formulation recipe, thereby preventing errors and ensuring product consistency.

2. Scope

This SOP applies to all raw materials that are weighed for the preparation of cream formulations within the Creams Department. It includes the process of weighing materials, cross-verifying the quantities, and ensuring the accuracy of measurements before materials are used in production.

3. Responsibilities

4. 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.

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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.
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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.
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6. Abbreviations

7. Documents

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

8. References

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
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