Manufacturing Department of the pharmaceutical formulation facility.

3. Responsibilities

• Production Officer: Ensures proper labeling and physical transfer to the quarantine area.
• Quality Assurance (QA): Ensures compliance with labeling standards and authorizes movement out of quarantine.
• Warehouse Staff: Manages space and environmental controls in the quarantine area.

4. Accountability

The Head – Manufacturing is accountable for the effective implementation of this SOP and ensuring adherence during audits.

5. Procedure

5.1 Label Preparation and Information

1. After the completion of bulk manufacturing, prepare the quarantine label as per format provided in Annexure-1.
2. Label must include the following information:
   • Product Name
   • Batch Number
   • Manufacturing Date
   • Storage Conditions
   • Quantity
   • Status: “Quarantine”
3. Label should be printed or handwritten legibly using indelible ink.

5.2 Label Application

1. Affix the label securely on the container body (not lid) to ensure it remains visible during handling.
2. Use weather-resistant adhesive labels for stainless steel tanks or high-density plastic containers.
3. Place an additional tag with batch number on the tank handle using a cable tie.

5.3 Quarantine Transfer

1. Transfer the labeled container to the designated quarantine area in the warehouse or manufacturing block.
2. Maintain an updated entry in the Quarantine Storage Log – Annexure-2.
3. Ensure storage under specified conditions (temperature, humidity) as mentioned in the label.

5.4 Quarantine Area Management

1. Quarantine area must be clearly demarcated with access restricted to authorized personnel only.
2. Install signage such as “QUARANTINE AREA – NO UNAUTHORIZED ACCESS”.
3. Environmental monitoring should be conducted and recorded daily.

5.5 Release or Rejection

1. QA will review the batch documents and sampling results.
2. If compliant, QA will replace the “Quarantine” label with “Approved for Use” status tag.
3. In case of rejection, affix “Rejected” tag and initiate deviation investigation as per applicable SOP.

6. Abbreviations

• QA: Quality Assurance
• GMP: Good Manufacturing Practice
• SOP: Standard Operating Procedure

7. Documents

1. Quarantine Label Template – Annexure-1
2. Quarantine Storage Log – Annexure-2
3. Batch Manufacturing Record (BMR)

8. References

• Schedule M Guidelines for Quarantine Management
• WHO GMP Guidelines for Storage and Distribution

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 Label Template

This label should contain: Product Name, Batch No., Mfg. Date, Quantity, Storage Conditions, Status (“Quarantine”).

Annexure-2: Quarantine Storage Log

Details to include: Container ID, Product Name, Batch No., Date In, Date Out, Storage Location, Verified By QA.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/05/2022	1.0	Initial SOP release	New procedure	QA Head
02/06/2025	2.0	Added dual label system and annexure log	Process clarity	QA Head