the sterile manufacturing facility.

3. Responsibilities

• Packaging Operator: Perform assigned checks and document results.
• IPQA Officer: Independently verify in-process checks, document deviations, and initiate CAPA if required.
• Packaging Supervisor: Ensure compliance with in-process checking protocol.

4. Accountability

The Head – Quality Assurance shall be accountable for implementation, compliance, and revision of this SOP.

5. Procedure

5.1 Types of In-Process Checks

1. Visual inspection of vials, ampoules, or prefilled syringes for:
   • Cracks, particles, color changes
   • Incorrect labeling or orientation
2. Label verification and legibility
3. Overprinting verification (Batch No., Mfg Date, Exp Date)
4. Sealing integrity of vials or syringes
5. Carton count and packaging insert verification
6. Shipper and pallet labeling checks

5.2 Frequency of Checks

1. Conduct in-process checks at the beginning of the batch and then at every 30-minute interval or as per SOP/SIM/XXX/2025.
2. Immediately record the results in Annexure-1.

5.3 Acceptable Criteria

1. All printed information must be legible and correct.
2. No leaks, broken containers, or improper seals.
3. Carton contents must match batch packaging record.

5.4 Handling of Deviations

1. Stop the packaging activity if any deviation is observed.
2. Inform the QA officer and initiate deviation report (Annexure-2).
3. Only resume after CAPA approval from QA.

5.5 Reconciliation

1. Ensure proper reconciliation of:
   • Primary packaging components
   • Printed secondary materials
2. Document the reconciliation in Annexure-3.

5.6 Review and Documentation

1. QA must review and sign off all in-process check records.
2. Ensure completeness and correctness before batch release.

6. Abbreviations

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

7. Documents

1. In-Process Packaging Check Sheet – Annexure-1
2. Deviation Report – Annexure-2
3. Reconciliation Record – Annexure-3

8. References

• WHO TRS 986 Annex 6: GMP for Sterile Products
• 21 CFR Part 211 – Finished Pharmaceuticals
• EudraLex Volume 4 – Annex 1

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: In-Process Packaging Check Sheet

Date	Time	Parameter Checked	Result	Checked By
18/06/2025	10:00	Label Alignment	OK	Sunita Rao

Annexure-2: Deviation Report

Date	Deviation Observed	Immediate Action	CAPA Proposed	QA Reviewed
18/06/2025	Faded overprint	Stopped Line	Printer calibration	Ramesh Iyer

Annexure-3: Reconciliation Record

Material	Issued	Used	Returned	Destroyed	Checked By
Labels	10000	9800	150	50	Sneha Kulkarni

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
15/03/2022	1.0	Initial SOP Release	New SOP	Head QA
18/06/2025	2.0	Added reconciliation and frequency update	Annual Review	Head QA