vials, ampoules, and prefilled syringes that require controlled temperature conditions during secondary and tertiary packaging.

3. Responsibilities

• Packaging Operators: Execute the packaging activity as per the SOP.
• QA Personnel: Verify temperature-sensitive packaging compliance and approve batch for dispatch.
• Warehouse Staff: Provide validated packaging materials and manage cold storage logistics.
• Engineering Team: Ensure temperature monitoring systems in packaging and storage areas are functional.

4. Accountability

The Head of Production and Head of Quality Assurance are accountable for ensuring adherence to this SOP and for maintaining packaging conditions suitable for temperature-sensitive injectable products.

5. Procedure

5.1 Preparation and Verification of Packaging Materials

1. Obtain the list of temperature-sensitive products to be packed from the production planner or batch processing record (BPR).
2. Ensure all secondary and tertiary packaging materials (insulated shippers, gel packs, thermal indicators) are available and validated for the specified temperature range (e.g., 2–8°C).
3. Check the calibration status of temperature monitoring devices (e.g., data loggers, IR thermometers).

5.2 Conditioning and Pre-Assembly

1. Precondition insulated shippers and gel packs as per vendor instructions or validation protocol.
2. Verify that conditioned materials are maintained within the required range before use.
3. Set up the packaging area within a temperature-controlled zone (if applicable) or monitor ambient temperature during the operation.

5.3 Packaging Process

1. Transfer labeled, packed primary units from cold room or refrigerated area to packaging area using validated cold boxes.
2. Insert temperature indicators or data loggers in each shipping unit as per the SOP.
3. Layer the secondary and tertiary components:
   • Line the insulated shipper with gel packs as per validated layout.
   • Place injectable units in sterile polybags or trays.
   • Insert product leaflet and label correctly.
   • Seal the shipper and apply external shipping label with temperature sensitivity warning.

5.4 Labeling and Documentation

1. Ensure that each package label includes:
   • Product name and strength
   • Batch number
   • Storage temperature range (e.g., “Store between 2°C and 8°C”)
   • Shipping and handling instructions
2. Record packaging details in the Temperature-Sensitive Packaging Log (Annexure-1).

5.5 Final QA Review and Release

1. QA shall:
   • Verify packaging against approved checklist
   • Confirm data logger configuration and functionality
   • Approve the release of final packed units

5.6 Transportation Coordination

1. Coordinate with the dispatch team and logistics provider to ensure cold chain continuity.
2. Review transportation SOP and instruct the carrier on necessary precautions.

5.7 Deviations and Corrective Actions

1. Record any observed temperature excursions in the deviation register.
2. Initiate CAPA and document findings in the deviation form (Annexure-2).

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• BPR: Batch Processing Record
• CAPA: Corrective and Preventive Action

7. Documents

1. Temperature-Sensitive Packaging Log – Annexure-1
2. Deviation Form – Annexure-2

8. References

• WHO Technical Report Series 961 – Annex 9: Model Guidance for the Storage and Transport of Time- and Temperature–Sensitive Pharmaceutical Products
• ICH Q10 – Pharmaceutical Quality System

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Packaging Executive	QA Executive	Head QA
Department	Sterile Injection Manufacturing	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Temperature-Sensitive Packaging Log

Date	Batch No.	Product	Pack Size	Shipper ID	Logger ID	Packaged By
24/06/2025	BTP-0256	Ceftriaxone 1g Injection	10 vials	SHIP-08	LOG-9234	Ravi Shankar

Annexure-2: Deviation Form

Deviation ID	Date	Description	Root Cause	CAPA	Closed By
DEV-074	24/06/2025	Temperature spike to 9°C during loading	Delay in cold van arrival	Vendor re-trained, response time SOP updated	Sunita Reddy

Revision History:

Revision Date	Revision No.	Revision Details	Reason	Approved By
01/05/2022	1.0	Initial release	New SOP	QA Head
24/06/2025	2.0	Updated procedure and annexures	Periodic Review	QA Head