Standard Operating Procedure for In-Process Checks during Packaging Operations
| Department | Sterile Injectable Manufacturing |
|---|---|
| SOP No. | SOP/SIM/100/2025 |
| Supersedes | SOP/SIM/100/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 18/06/2025 |
| Effective Date | 20/06/2025 |
| Review Date | 18/06/2026 |
1. Purpose
To establish a standardized procedure for conducting in-process checks during the packaging of sterile injectable products to ensure compliance with GMP and product specifications.
2. Scope
This SOP is applicable to all packaging lines used for sterile injectable vials, ampoules, and prefilled syringes in
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
- Visual inspection of vials, ampoules, or prefilled syringes for:
- Cracks, particles, color changes
- Incorrect labeling or orientation
- Label verification and legibility
- Overprinting verification (Batch No., Mfg Date, Exp Date)
- Sealing integrity of vials or syringes
- Carton count and packaging insert verification
- Shipper and pallet labeling checks
5.2 Frequency of Checks
- Conduct in-process checks at the beginning of the batch and then at every 30-minute interval or as per SOP/SIM/XXX/2025.
- Immediately record the results in Annexure-1.
5.3 Acceptable Criteria
- All printed information must be legible and correct.
- No leaks, broken containers, or improper seals.
- Carton contents must match batch packaging record.
5.4 Handling of Deviations
- Stop the packaging activity if any deviation is observed.
- Inform the QA officer and initiate deviation report (Annexure-2).
- Only resume after CAPA approval from QA.
5.5 Reconciliation
- Ensure proper reconciliation of:
- Primary packaging components
- Printed secondary materials
- Document the reconciliation in Annexure-3.
5.6 Review and Documentation
- QA must review and sign off all in-process check records.
- 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
- In-Process Packaging Check Sheet – Annexure-1
- Deviation Report – Annexure-2
- 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 |