Ointments: SOP for Addressing Deviations in Dispensed Quantities – V 2.0

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SOP for Addressing Deviations in Dispensed Quantities – V 2.0

Procedure for Addressing Deviations in Dispensed Quantities

Department Production/Quality Assurance (QA)/Quality Control (QC)/Warehouse
SOP No. SOP/Ointment/179
Supersedes V 1.0
Page No. Page X of Y
Issue Date [Insert Issue Date]
Effective Date [Insert Effective Date]
Review Date [Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a structured approach for identifying, investigating, and addressing deviations in dispensed raw material quantities. Proper handling of deviations ensures batch consistency, prevents formulation errors, and maintains compliance with Good Manufacturing Practices (GMP) and regulatory requirements.

2. Scope

This SOP applies to all personnel responsible for weighing, dispensing, verifying, and approving raw materials in the Production, Quality Assurance (QA), Quality Control (QC), and Warehouse departments.

3. Responsibilities

  • Dispensing Operator: Ensures proper weighing and reports any deviations immediately.
  • QA Officer: Reviews and approves corrective actions for any deviations.
  • QC Analyst: Verifies dispensed quantities and investigates potential issues.
  • Warehouse Supervisor: Ensures materials are correctly labeled and stored after weighing.
  • Production Supervisor: Oversees the dispensing process and coordinates deviation resolution.
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4. Accountability

The QA Manager is accountable for ensuring that all deviation handling activities comply with GMP, FDA, ICH, WHO, and company policies.

5. Procedure

5.1 Identification of Dispensing Deviations

A deviation occurs when the dispensed quantity of raw material does not match the prescribed amount in the Batch Manufacturing Record

(BMR) within the approved tolerance limit.

  • Common causes of deviations include:
    • Operator error in weighing.
    • Weighing balance calibration issues.
    • Material loss during transfer.
    • Environmental factors affecting material stability.
  • Deviation categories:
    • Minor Deviation: Dispensed weight is within a ±1% variance.
    • Major Deviation: Dispensed weight exceeds ±1% variance.
    • Critical Deviation: Dispensed weight leads to non-compliance or affects product quality.

5.2 Immediate Actions Upon Identifying a Deviation

  • Stop the dispensing process immediately.
  • Segregate and label the affected material as **”Hold for Investigation.”**
  • Notify the QA department and Production Supervisor.
  • Record the deviation in the **Dispensing Deviation Log (Annexure-1).**
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5.3 Investigation of Deviation

  • QA must review the **weighing logs, equipment calibration records, and environmental monitoring data.**
  • QC must reweigh the material to verify accuracy.
  • If equipment malfunction is suspected:
    • The balance must be recalibrated immediately.
    • All materials dispensed using the faulty balance must be reviewed.
  • If operator error is confirmed:
    • The operator must be retrained on proper weighing techniques.
    • A Corrective and Preventive Action (CAPA) plan must be implemented.

5.4 Corrective and Preventive Actions (CAPA)

  • Corrective Actions:
    • Reweigh the material under QA supervision.
    • Adjust the batch formulation accordingly.
    • Quarantine and dispose of excess or contaminated material.
  • Preventive Actions:
    • Ensure regular calibration of weighing balances.
    • Implement double-checking of weights by a second operator.
    • Improve documentation and material handling procedures.

5.5 Post-Deviation Documentation

  • Ensure that all deviations and corrective actions are documented in the **Deviation Report (Annexure-2).**
  • QA must review and approve all corrective actions before the batch is released for further processing.
  • Retain records for **five years** for audit and compliance purposes.
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6. Abbreviations

  • GMP – Good Manufacturing Practices
  • QA – Quality Assurance
  • QC – Quality Control
  • BMR – Batch Manufacturing Record
  • FDA – Food and Drug Administration
  • ICH – International Council for Harmonisation

7. Documents

  • Dispensing Deviation Log (Annexure-1)
  • Deviation Report (Annexure-2)

8. References

  • ICH Q7 – GMP for Active Pharmaceutical Ingredients
  • WHO Guidelines on Raw Material Handling
  • FDA Guidance on Pharmaceutical Manufacturing

9. SOP Version

Version 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Dispensing Deviation Log

Date Material Name Batch No. Dispensed Quantity Deviation Type Operator QA Review
02/02/2025 API X SOP/Ointment/1001 5.2 kg Overweight John Doe Approved

Annexure-2: Deviation Report

Date Material Name Batch No. Deviation Type Root Cause Corrective Action QA Approval
02/02/2025 API X SOP/Ointment/1001 Overweight Operator Error Reweighed and Adjusted Approved

12. Revision History

Revision Date Revision No. Details Reason Approved By
02/02/2025 2.0 Expanded Deviation Handling Procedures Improved Compliance QA Head
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