SOP Guide for Pharma

Creams: SOP for Handling Discrepancies in Dispensing Weights – V 2.0

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Creams: SOP for Handling Discrepancies in Dispensing Weights – V 2.0

Standard Operating Procedure for Handling Discrepancies in Dispensing Weights

Department Creams
SOP No. SOP/CRM/017/2025
Supersedes SOP/CRM/017/2022
Page No. Page 1 of 5
Issue Date 20/05/2025
Effective Date 25/05/2025
Review Date 20/05/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide the process for handling discrepancies in dispensing weights during cream manufacturing. It ensures that any deviations from the prescribed quantities are identified, documented, and corrected in a timely and effective manner to maintain product quality and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all dispensing activities within the Creams Department, specifically focusing on discrepancies related to the weight of ingredients dispensed during cream formulation. It includes the identification, reporting, and corrective actions associated with any weight discrepancies.

3. Responsibilities

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.

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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.
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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.
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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

7. Documents

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

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: 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
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