Standard Operating Procedure for Transfer of Materials to Quarantine Area Post Dispensing

Department	Elixir Department
SOP No.	SOP/ELX/023/2025
Supersedes	SOP/ELX/023/2022
Page No.	Page 1 of 8
Issue Date	13/04/2025
Effective Date	15/04/2025
Review Date	13/04/2026

1. Purpose

To define the procedure for the safe, traceable, and compliant transfer of remaining or partially used raw materials to the quarantine area after dispensing in the Elixir Department, as per GMP requirements.

2. Scope

This SOP applies to all remaining raw material containers (API, excipients, solvents) after dispensing activity is completed for any batch in the Elixir manufacturing unit.

3. Responsibilities

• Dispensing Operator:
  • Ensure remaining materials are properly labeled, sealed, and handed over for quarantine.
• Warehouse Staff:
  • Transport materials back to the quarantine area with proper documentation.
• QA Officer:
  • Verify labeling, segregation, and storage conditions in the quarantine area.

4. Accountability

The Head of QA and Head of Warehouse are accountable for implementation and verification of this procedure.

5. Procedure

5.1 Preparation of Material for Return

1. Immediately after completion of dispensing:
   • Close the container securely using tamper-evident closures or lids.
   • Wipe the outer surface using a lint-free cloth soaked in 70% IPA.
2. Affix “Partially Used” label with the following details:
   • Material Name
   • Batch Number
   • Remaining Quantity
   • Date of Dispensing
   • Signature of Operator

5.2 Documentation

1. Record the return of materials in the Material Movement Register (Annexure-1).
2. QA to cross-check with the original Material Issue Slip and Dispensing Log.
3. Enter the following in the log:
   • Material Code
   • Returned Qty
   • Container ID
   • Returned By
   • Verified By

5.3 Transport to Quarantine Area

1. Ensure transport trolley is clean and covered.
2. Use dedicated pathways to avoid mix-ups with approved materials.
3. Hand over materials to the quarantine storekeeper and obtain acknowledgment.

5.4 Storage in Quarantine Area

1. Store returned materials in a designated quarantine rack or section.
2. Separate materials by status – ‘To Be Re-tested,’ ‘To Be Disposed,’ or ‘For Re-approval.’
3. Maintain controlled temperature and humidity as per material specification.

5.5 Further Actions

1. QA to decide disposition:
   • If within expiry and uncontaminated – send for re-testing or re-approval.
   • If expired or not suitable for reuse – dispose as per SOP for waste handling.
2. Record final decision in Material Disposition Register.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• IPA: Isopropyl Alcohol

7. Documents

1. Material Movement Register (Annexure-1)
2. Partial Use Label Template
3. Material Disposition Register

8. References

• WHO TRS 986 Annex 2 – GMP for Non-Sterile Pharmaceuticals
• 21 CFR Part 211 – Subpart E

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 Movement Register

Date	Material Name	Batch No.	Returned Qty	Returned By	Verified By	Remarks
13/04/2025	Sorbitol	SB0425	2.0 kg	Rajesh Kumar	Sunita Reddy	Sealed and labeled

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
10/01/2022	1.0	Initial Release	New SOP	QA Head
13/04/2025	2.0	Added material status segregation and disposition tracking	Audit Requirement	QA Head