and secondary packaging materials including labels, cartons, inserts, trays, caps, seals, vials, and prefilled syringe components received and stored at the sterile injectable manufacturing site.

3. Responsibilities

• Store Assistant: Receives and stores packaging materials as per defined protocol.
• Quality Control: Performs sampling and inspection of received materials.
• Quality Assurance: Approves materials for use and ensures GMP compliance.

4. Accountability

The Head of Stores is accountable for implementation and adherence to this SOP.

5. Procedure

5.1 Receipt and Initial Handling

1. Receive packaging materials against approved purchase orders.
2. Check the consignment for physical damage, labeling, and quantity against delivery challan.
3. Quarantine received materials in a designated area with “UNDER TEST” status labels (Annexure-1).
4. Update the Packaging Material Receipt Log (Annexure-2).

5.2 Sampling and Quality Control Testing

1. QC personnel shall draw samples as per SOP/QC/PM/022 for testing.
2. Samples shall be identified with “SAMPLE UNDER TEST” tags.
3. After approval, QA will affix “APPROVED” or “REJECTED” labels accordingly.

5.3 Segregation and Labeling

1. Store approved, rejected, and under-test materials in physically segregated areas.
2. Ensure clear visual identification with color-coded status labels.
3. Maintain FIFO (First In, First Out) system for inventory rotation.

5.4 Storage Conditions

1. Store materials at defined temperature and humidity conditions as specified in supplier CoA or internal SOPs.
2. Monitor and record environmental conditions twice daily using calibrated data loggers (Annexure-3).
3. Do not stack materials beyond specified pallet heights.

5.5 Issuance for Use

1. Issue only “APPROVED” packaging materials based on material requisition slips.
2. Update the Packaging Material Issuance Log (Annexure-4) accordingly.
3. Cross-verify material name, item code, batch number, and quantity before dispatch to production.

5.6 Handling of Rejected Materials

1. Store rejected materials in a separate lock-and-key area labeled “REJECTED.”
2. Initiate material return or destruction as per SOP/WHS/004.

5.7 Record Keeping

1. All records including receipt logs, test status, label history, and issuance records must be retained for a minimum of five years or as per regulatory requirements.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• FIFO: First In First Out
• CoA: Certificate of Analysis

7. Documents

1. Status Label Log – Annexure-1
2. Packaging Material Receipt Log – Annexure-2
3. Storage Condition Monitoring Log – Annexure-3
4. Packaging Material Issuance Log – Annexure-4

8. References

• WHO TRS 986 Annex 2: GMP for Pharmaceutical Products
• EU GMP Guidelines – Chapter 5: Production
• 21 CFR Part 211 – Subpart G: Packaging and Labeling Control

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Status Label Log

Material Name	Label Applied	Date	By Whom
Glass Vials 10 mL	UNDER TEST	17/06/2025	Sunita Reddy

Annexure-2: Packaging Material Receipt Log

Date	Material	Qty	Batch No.	Received By
16/06/2025	Labels 1 mL Vial	20,000	LBL-2025-012	Rajesh Kumar

Annexure-3: Storage Condition Monitoring Log

Date	Time	Temperature (°C)	Humidity (%)	Checked By
18/06/2025	10:00 AM	24.0	50	Ravi Deshmukh

Annexure-4: Packaging Material Issuance Log

Material	Issued Qty	Batch No.	Date	Issued To
Cartons 1 mL Vial	10,000	INJ-096	18/06/2025	Production – Line 1

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
02/04/2022	1.0	Initial SOP	New release	Head QA
18/06/2025	2.0	Storage log and issuance log formats updated	GMP alignment	Head QA