Creams: SOP for Handling Rejected or Returned Materials in Dispensing – V 2.0

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Creams: SOP for Handling Rejected or Returned Materials in Dispensing – V 2.0

Standard Operating Procedure for Handling Rejected or Returned Materials in Dispensing

Department Creams
SOP No. SOP/CRM/019/2025
Supersedes SOP/CRM/019/2022
Page No. Page 1 of 5
Issue Date 30/05/2025
Effective Date 05/06/2025
Review Date 30/05/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the proper handling of rejected or returned materials during the dispensing process in cream manufacturing. This ensures that all returned or rejected materials are appropriately segregated, documented, and either reprocessed, discarded, or returned to their proper storage location according to GMP standards.

2. Scope

This SOP applies to all materials that are rejected or returned during the dispensing process in the Creams Department. It covers the procedures for identifying, segregating, documenting, and managing rejected or returned materials to prevent cross-contamination and ensure that the materials are either appropriately reprocessed or disposed of.

3. Responsibilities

  • Production Personnel: Responsible for identifying and segregating rejected or returned materials, ensuring that they are properly labeled and handled according to this SOP.
  • Quality Control (QC): Ensures that all rejected or returned materials are thoroughly inspected for contamination or quality issues. QC verifies that the materials are appropriately labeled, segregated, and documented.
  • Quality Assurance (QA): Oversees the handling of rejected or returned materials, ensuring compliance with this SOP. QA is responsible for reviewing documentation and approving the appropriate disposition of the materials.
  • Warehouse Personnel: Ensures that rejected or returned materials are stored in a designated area and that any materials returned to stock are properly documented and labeled.
See also  Creams: SOP for Material Transfer from Dispensing Area to Production Area - V 2.0

4. Accountability

The Head of Creams Manufacturing is responsible for ensuring that rejected or returned materials are properly handled according to this SOP. The QA Manager is responsible for overseeing the proper documentation, investigation, and final disposition of rejected or returned materials.

5. Procedure

5.1 Identification of Rejected or Returned Materials

  1. Materials are considered rejected or returned if they fail to meet the required specifications, are improperly labeled, or are inadvertently dispensed in excess or under the incorrect formulation.
  2. Rejected or returned materials can also result from discrepancies discovered during the weighing, dispensing, or inspection process, or due to environmental factors that may affect the integrity of the materials.
  3. Upon identification, rejected or returned materials must be immediately segregated from other materials to prevent contamination.

5.2 Segregation and Labeling

  1. Rejected or returned materials must be stored in a designated quarantine area to prevent accidental use or contamination with other materials.
  2. Each container of rejected or returned materials must be clearly labeled as “Rejected” or “Returned” with the following information:

    • Material name
    • Batch number
    • Reason for rejection or return
    • Date of rejection or return
    • Person responsible for the rejection/return
  3. Ensure that materials are not returned to production unless they are thoroughly inspected, cleared for re-use, and approved by the QA team.

5.3 Documentation of Rejected or Returned Materials

  1. All rejected or returned materials must be documented in the Rejected/Returned Materials Log. This log should include the following:

    • Material name
    • Batch number
    • Reason for rejection or return
    • Quantity rejected or returned
    • Actions taken (rework, disposal, etc.)
    • Personnel involved
  2. A Material Discrepancy Report must be generated for each rejected or returned material, detailing the nature of the discrepancy and any corrective actions taken.
  3. Ensure that all documentation is signed by the responsible personnel and reviewed by the QA team for completeness and accuracy.
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5.4 Disposition of Rejected or Returned Materials

  1. The QA team will review all rejected or returned materials to determine the appropriate disposition. The options for disposition include:

    • Reworking the material to bring it into specification
    • Returning the material to stock (only if it is still within its shelf life and properly documented)
    • Disposing of the material in accordance with safety and environmental regulations
  2. For materials that are to be reworked, ensure that all rework procedures are documented and the material is thoroughly tested to verify its compliance with specifications before being used in production.
  3. For materials that are to be disposed of, ensure that they are disposed of in a safe and environmentally responsible manner, in accordance with company policies and regulatory requirements.

5.5 Review and Approval

  1. The QA team will review all rejected/returned materials and the corresponding documentation to ensure that proper procedures were followed.
  2. Once the materials are disposed of, reworked, or returned to stock, the QA team will finalize the documentation, and the materials will be cleared for either re-use or disposal.
  3. The QA team will ensure that any trends or recurring issues with rejected or returned materials are analyzed and addressed through corrective actions or process improvements.
See also  Creams: SOP for Dispensing Raw Materials for Cream Formulations - V 2.0

6. Abbreviations

  • QC: Quality Control
  • QA: Quality Assurance
  • GMP: Good Manufacturing Practices

7. Documents

  1. Rejected/Returned Materials Log (Annexure-1)
  2. Material Discrepancy Report (Annexure-2)
  3. Corrective Action Report (Annexure-3)

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 Handling and Disposal

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/Returned Materials Log

Material Name Batch Number Quantity Reason for Rejection/Return Disposition Responsible Personnel
Colorant A 12345 200g Expired Disposed Jane Smith

Annexure-2: Material Discrepancy Report

Material Name Batch Number Discrepancy Description Corrective Action Taken Reported By Resolution Date
Preservative A 67890 Incorrect labeling Re-labeled and quarantined John Doe 01/06/2025

Annexure-3: Corrective Action Report

Deviation Corrective Action Taken Responsible Person Completion Date
Expired Material Reviewed supplier inventory, updated rotation system Jane Smith 02/06/2025

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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