Completes the packing records in real-time and ensures legibility and accuracy.

IPQA Officer: Verifies the completeness of the packing documents and ensures compliance with SOP requirements.

Production Pharmacist: Ensures all documents are reviewed and forwarded to QA on batch completion.

4. Accountability

The Head of Quality Assurance is accountable for reviewing and approving packing documentation for compliance and release of the product.

5. Procedure

5.1 Documentation Requirements

1. All packing activities must be documented in the respective Packing Batch Manufacturing Record (PBMR).
2. Entries must be made in black or blue indelible ink, legibly, without overwriting. Any corrections must be signed, dated, and justified.
3. Use only authorized templates provided by the QA department for all packing logs and records.

5.2 Documents to be Maintained

1. Primary and secondary packaging material usage log.
2. Machine cleaning and line clearance checklist (Annexure-1).
3. Carton, label, and insert reconciliation sheet (Annexure-2).
4. Packing area environmental monitoring data.
5. In-process checks for label placement, seal integrity, batch coding accuracy.

5.3 Real-Time Entry

1. All activities must be recorded immediately after completion of the respective task.
2. Ensure that start and end times of each packing operation (e.g., vial labeling, syringe insertion) are recorded with operator signatures.

5.4 Verification and Review

1. The IPQA officer shall verify each completed entry, including:
   • Correct label and carton match to product specification.
   • Reconciliation data for packaging components.
2. Discrepancies shall be recorded in the deviation form and escalated as per the deviation management SOP.

5.5 Record Submission and Retention

1. Upon batch completion, the packaging records shall be submitted to the QA department within 24 hours.
2. Records must be retained in the designated archival area for a minimum of 5 years or as per regulatory requirement.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• PBMR: Packing Batch Manufacturing Record
• IPQA: In-Process Quality Assurance

7. Documents

1. Machine Cleaning and Line Clearance Checklist – Annexure-1
2. Carton and Label Reconciliation Sheet – Annexure-2
3. Packing Activity Log Sheet – Annexure-3

8. References

• EU GMP Part I Chapter 4 – Documentation
• WHO Technical Report Series No. 996
• 21 CFR Part 211.188 – Batch production and control records

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: Machine Cleaning and Line Clearance Checklist

Date	Machine ID	Cleaned By	Checked By	Status
15/06/2025	PKG-01	Sunil Patil	Manoj Yadav	Clear

Annexure-2: Carton and Label Reconciliation Sheet

Batch No.	Cartons Issued	Cartons Used	Labels Issued	Labels Used	Balance
INJ-098	10,000	9,950	10,000	9,950	50

Annexure-3: Packing Activity Log Sheet

Date	Activity	Start Time	End Time	Performed By
15/06/2025	Vial Labeling	09:00	11:30	Deepika Mehra

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
10/03/2022	1.0	Initial version	New SOP	Head QA
18/06/2025	2.0	Format update and inclusion of real-time entry guideline	Periodic Review	Head QA