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Ointments: SOP for Handling Rejected Packed Units – V 2.0

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SOP for Handling Rejected Packed Units – V 2.0

Procedure for Handling Rejected Packed Units

Department Packaging/Quality Assurance (QA)/Production
SOP No. SOP/Ointment/100
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 systematic process for handling rejected packed units in ointment packaging. This ensures product quality, compliance with Good Manufacturing Practices (GMP), and proper documentation of non-conforming products.

2. Scope

This SOP applies to all personnel in the Packaging, Quality Assurance (QA), and Production departments responsible for identifying, segregating, investigating, and disposing of rejected packed units.

3. Responsibilities

  • Packaging Operator: Identifies and segregates rejected packed units.
  • Packaging Supervisor: Records and reports rejected units for further investigation.
  • Quality Assurance (QA) Officer: Evaluates rejection reasons and recommends corrective actions.
  • QA Manager: Approves final disposition of rejected packed units.
See also  Ointments: SOP for Using a Homogenizer in Ointment Production - V 2.0

4. Accountability

The QA and Packaging Managers are accountable for ensuring that rejected packed units are properly handled, documented, and disposed of per regulatory requirements.

5. Procedure

5.1 Identification of Rejected Packed Units

  • Conduct routine inspections to identify defective or non-conforming packed units.
  • Common rejection reasons include:
    • Incorrect or missing labels
    • Damaged or leaking ointment tubes
    • Misprinted batch numbers or expiry dates
    • Improper sealing or tamper evidence issues
    • Packaging material defects (e.g., torn cartons, misaligned inserts)

5.2 Segregation and Quarantine

  • Place rejected packed
units in a designated rejection area.
  • Clearly label rejected units with “REJECTED – DO NOT USE” tags.
  • Maintain a rejection log for traceability.
  • 5.3 Investigation and Root Cause Analysis

    • QA must analyze rejection trends to determine potential root causes.
    • Use Corrective and Preventive Action (CAPA) to address recurring issues.
    • Perform re-evaluation if required and document findings.

    5.4 Disposition of Rejected Units

    • Based on QA evaluation, rejected units may be:
      • Reprocessed (if feasible and within GMP limits)
      • Reworked (e.g., re-labeling, repackaging)
      • Destroyed (if unfit for use and beyond salvage)
    • QA must approve and document the final disposition method.

    5.5 Documentation and Record Keeping

    • Record all rejected packed units in the Rejection Log.
    • Maintain documentation for regulatory audits and traceability.
    • Ensure final approval and closure of the rejection case by QA.

    6. Abbreviations

    • GMP – Good Manufacturing Practices
    • QA – Quality Assurance
    • QC – Quality Control
    • CAPA – Corrective and Preventive Action

    7. Documents

    • Rejected Packed Units Log (Annexure-1)
    • Final Disposition Report (Annexure-2)

    8. References

    • WHO GMP Guidelines for Pharmaceutical Manufacturing
    • ICH Q10 – Pharmaceutical Quality System
    • USP <41> – Weights and Balances

    9. SOP Version

    Version 2.0

    10. Approval Section

    Prepared By Checked By Approved By
    Signature
    Date
    Name
    Designation
    Department

    11. Annexures

    Annexure-1: Rejected Packed Units Log

    Date Batch Number Rejection Reason Quantity Rejected Recorded By Remarks
    01/02/2025 OINT-101 Leaking Tube 10 Packaging Supervisor Segregated
    01/02/2025 OINT-102 Incorrect Expiry Date 5 QA Officer To be reworked

    Annexure-2: Final Disposition Report

    Date Batch Number Rejection Category Disposition Method Final Approval
    01/02/2025 OINT-101 Packaging Defect Destroyed QA Manager
    02/02/2025 OINT-102 Labeling Error Reworked QA Manager

    12. Revision History:

    Revision Date Revision No. Details of Revision Reason for Revision Approved By
    01/01/2024 1.0 Initial Version New SOP QA Head
    01/02/2025 2.0 Updated SOP Format Standardization of Document QA Head
    Ointments V 2.0 Tags:Ointment application SOP, Ointment batch record SOP, Ointment compounding SOP, Ointment dispensing SOP, Ointment filling SOP, Ointment formulation SOP, Ointment manufacturing SOP, Ointment microbiological testing SOP, Ointment pH testing SOP, Ointment production SOP, Ointment quality control SOP, Ointment stability study SOP, Pharmaceutical ointment SOP, SOP for ointment homogenization, SOP for ointment labeling, SOP for ointment mixing, SOP for ointment packaging, SOP for ointment preparation, SOP for ointment raw material testing, SOP for ointment shelf-life determination, SOP for ointment stability testing, SOP for ointment sterilization, SOP for ointment storage, SOP for ointment testing, SOP for ointment viscosity testing

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    Standard Operating Procedures V 1.0

    • Aerosols
    • Analytical Method Development
    • Bioequivalence Bioavailability Study
    • Capsule Formulation
    • Clinical Studies
    • Creams
    • Data Integrity
    • Dental Dosage Forms
    • Drug Discovery
    • Environment, Health and Safety
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    • Powder & Granules
    • Purchase Departments
    • Quality Assurance
    • Quality Control
    • Raw Material Stores
    • Regulatory Affairs
    • Tablet Manufacturing
    • Rectal Dosage Forms
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    • Validations and Qualifications

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    NEW! Revised SOPs – V 2.0

    • Aerosols V 2.0
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    • BA-BE Studies V 2.0
    • Capsules V 2.0
    • Creams V 2.0
    • Ointments V 2.0
    • Raw Material Warehouse V 2.0
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