until they are released by the Quality Assurance department.

3. Responsibilities

• Warehouse Personnel: Store packaged gels in the designated quarantine area and maintain inventory logs.
• Quality Assurance: Inspect and approve or reject batches for release from quarantine.
• Production Staff: Ensure correct transfer of finished goods to quarantine zone.
• Store Supervisor: Ensure SOP compliance and coordination with QA for timely release.

4. Accountability

The Head – Manufacturing is accountable for the integrity and regulatory compliance of packaged gel storage operations.

5. Procedure

5.1 Transfer to Quarantine Area

1. Upon completion of packaging and labeling, production staff must transfer the packaged gels to the quarantine area.
2. Ensure each shipper/carton is labeled with batch number, product name, packaging date, and “QUARANTINE” status.
3. Fill out the transfer record and inform QA for acknowledgment (Annexure-1).

5.2 Quarantine Area Conditions

1. Maintain temperature and humidity as specified in product storage requirements (typically 15–25°C, <60% RH).
2. Segregate batches physically to prevent mix-ups and cross-contamination.
3. Prohibit access to unauthorized personnel.
4. Monitor environmental parameters continuously and record in the Quarantine Storage Log (Annexure-2).

5.3 Handling During Quarantine

1. Do not move, sample, or ship any product from the quarantine area without QA clearance.
2. Place damaged or suspected units in a separate “Hold” zone with appropriate labels.
3. Conduct routine cleaning and pest control as per SOPs for warehouse hygiene.

5.4 Batch Release

1. QA will conduct batch review, visual inspection, and verify test reports.
2. If approved, QA will issue a Batch Release Certificate and remove the “Quarantine” tag.
3. Update the quarantine log and transfer the batch to the released goods area for dispatch.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• RH: Relative Humidity
• BMR: Batch Manufacturing Record

7. Documents

1. Quarantine Transfer Record – Annexure-1
2. Quarantine Environmental Log – Annexure-2
3. Batch Release Certificate
4. Cleaning Logbook for Storage Area

8. References

• WHO TRS 961 – Good Storage Practices
• Schedule M – Storage Section
• FDA CFR 21 Part 211.142 – Warehousing Procedures

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Quarantine Transfer Record

Date	Batch No.	Product Name	No. of Units	Transferred By	Received By	Remarks

Annexure-2: Quarantine Environmental Log

Date	Time	Temperature (°C)	RH (%)	Recorded By	Remarks

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
03/06/2022	1.0	Initial Release	New SOP	QA Head
02/06/2025	2.0	Updated quarantine handling and temperature range	Periodic Review	QA Head