line in the manufacturing department at [Company Name]. It includes setup, operation, visual inspection, labeling, and documentation.

3. Responsibilities

• Machine Operators: Operate, monitor, and record machine parameters and product status.
• Maintenance Team: Ensure maintenance, calibration, and troubleshooting of equipment.
• QA Officers: Ensure compliance with in-process controls and validate process conditions.

4. Accountability

The Manufacturing Head is accountable for execution of the SOP. QA Head is accountable for compliance with GMP and documentation integrity.

5. Procedure

5.1 Preparation

1. Ensure cleanroom gowning is complete and compliant with aseptic entry protocol.
2. Verify line clearance is performed and approved by QA before starting operations.
3. Review the batch manufacturing record (BMR) for accuracy and readiness.

5.2 Line Setup

1. Assemble machine components like plunger rods, finger flanges, barrels, and needle guards as per validated layout.
2. Verify prefilled syringes have passed through appropriate visual and leak integrity checks.
3. Load prefilled barrels, plungers, and accessories in designated hoppers.
4. Set parameters on the HMI panel, such as torque for plunger insertion, speed of belt drive, and rejection logic.

5.3 Operation

1. Initiate the process with machine interlock validation and start the main assembly sequence.
2. Monitor the following:
   • Insertion of plungers to correct depth
   • Fixing of finger flange components
   • Application of needle safety guard
3. Reject defective units via auto-rejection system and document rejections in Annexure-1.

5.4 In-Process Checks

1. Perform in-process checks every 30 minutes:
   • Plunger depth using go/no-go gauge
   • Plunger torque test
   • Component orientation verification
2. Document findings in In-Process Inspection Log (Annexure-2).

5.5 Environmental Monitoring

1. Verify differential pressure, temperature, and RH at start and every 2 hours.
2. Ensure Grade A/B compliance in the machine operation area.

5.6 Documentation

1. Ensure all machine logs, process observations, and incident logs are updated in real time.
2. QA reviews documentation and signs off after batch completion.

5.7 Line Clearance Post-Batch

1. After batch completion, perform visual clearance.
2. Document clearance in Line Clearance Form (Annexure-3).

6. Abbreviations

• SOP: Standard Operating Procedure
• PFS: Prefilled Syringe
• QA: Quality Assurance
• RH: Relative Humidity
• HMI: Human-Machine Interface
• BMR: Batch Manufacturing Record

7. Documents

1. Defect Rejection Log – Annexure-1
2. In-Process Inspection Log – Annexure-2
3. Line Clearance Form – Annexure-3

8. References

• EU-GMP Annex 1 – Manufacture of Sterile Medicinal Products
• WHO TRS 961 Annex 6
• ISO 11040 – Prefilled Syringes Standard

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: Defect Rejection Log

Date	Batch No.	Defect Type	Quantity	Operator
24/06/2025	PFS125A	Plunger Misalignment	15	Ravi Joshi

Annexure-2: In-Process Inspection Log

Date	Time	Check Parameter	Result	Checked By
24/06/2025	10:30 AM	Plunger Depth	Within Limit	Meena Iyer

Annexure-3: Line Clearance Form

Date	Batch No.	Cleared By	Remarks
24/06/2025	PFS125A	Sunita Reddy	Area Clean & Clear

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
10/01/2022	1.0	Initial Release	New Equipment	QA Head
24/06/2025	2.0	Format and Parameter Updates	Periodic Review	QA Head