in handling, transferring, and storing finished sterile injectable products across production, in-process storage, and finished goods warehouse areas.

3. Responsibilities

• Production Personnel: Ensure proper labeling and batch identification during transfer from manufacturing to storage.
• Warehouse Staff: Maintain physical segregation and record receipt in respective batch-wise logs.
• Quality Assurance: Verify segregation, labeling, and compliance during line clearance and storage checks.
• Head – Production: Ensure implementation and training of this SOP.

4. Accountability

The Head of Quality Assurance is accountable for ensuring compliance with segregation procedures and documentation accuracy.

5. Procedure

5.1 Batch Identification during Transfer

1. After final packaging and reconciliation, ensure all outer cartons are labeled with:
   • Product name
   • Batch number
   • Manufacturing and expiry date
   • Quantity per carton
2. Affix color-coded batch tags (Refer Annexure-1: Batch Tag Format).

5.2 Segregation Protocol in Storage Areas

1. Transport finished products to designated quarantine or finished goods area using sanitized trolleys.
2. Place batch lots in demarcated areas using batch separation boards or physical barriers.
3. Label rack or floor area with batch number and quarantine status.

5.3 Warehouse Storage and Logging

1. Verify product count, batch labels, and integrity before accepting into warehouse.
2. Log product details in Finished Product Receipt Logbook (Annexure-2).
3. Segregate products from other batches using color-coded zones or physical dividers.

5.4 QA Verification and Release Status

1. QA to verify labeling, storage location, and batch ID during in-process audit.
2. Only QA may update status from “Quarantine” to “Released” after final review and CoA approval.
3. Update status tags with green “Released” label (Refer Annexure-3: Status Label Format).

5.5 Handling Mixed Batch Returns or Rejections

1. Any returned or rejected items must be re-verified for batch identity and stored separately under “Hold” status.
2. Update Returned Product Log (Annexure-4).

5.6 Deviation and Non-Compliance Management

1. Any observation of mix-up, incorrect labeling, or improper segregation shall be logged as a deviation (Refer Annexure-5: Deviation Log).
2. Initiate CAPA based on root cause analysis.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• GMP: Good Manufacturing Practice
• CAPA: Corrective and Preventive Action

7. Documents

1. Batch Tag Format – Annexure-1
2. Finished Product Receipt Logbook – Annexure-2
3. Status Label Format – Annexure-3
4. Returned Product Log – Annexure-4
5. Deviation Log – Annexure-5

8. References

• WHO GMP Guidelines
• EU GMP Annex 15
• ICH Q10 – Pharmaceutical Quality System

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: Batch Tag Format

Batch No.	Product Name	Date	Quantity	Status
INJ/092/2025	Ceftriaxone 1g	22/06/2025	2000 Vials	Quarantine

Annexure-2: Finished Product Receipt Logbook

Date	Batch No.	Product	Qty	Storage Location	Received By
22/06/2025	INJ/092/2025	Ceftriaxone	2000	Rack A2	Sunil Mehra

Annexure-3: Status Label Format

Batch No.	INJ/092/2025
Status	Released
QA Approval	Sunita Reddy
Date	23/06/2025

Annexure-4: Returned Product Log

Date	Batch	Qty	Reason	Disposition
23/06/2025	INJ/089/2025	50	Seal Damage	Hold

Annexure-5: Deviation Log

Deviation No.	Date	Observation	Action Taken	Reviewed By
DEV-137-01	21/06/2025	Mixed batch labels found	Segregated and relabeled	QA Executive

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/07/2022	1.0	Initial release	New SOP	QA Head
24/06/2025	2.0	Expanded on QA verification steps	Periodic Review	QA Head