product integrity and regulatory compliance.

2. Scope

This SOP applies to trained production personnel operating automatic or semi-automatic vial/syringe filling machines in the sterile injectable manufacturing area.

3. Responsibilities

• Machine Operator: Operates the filling machine as per validated parameters and records necessary observations.
• Production Supervisor: Verifies setup, ensures readiness of the equipment, and monitors operational compliance.
• QA Officer: Performs in-process checks and verifies batch-related documentation.

4. Accountability

The Head of Production is accountable for ensuring that filling machines are operated only by trained personnel and as per validated procedures.

5. Procedure

5.1 Pre-Operation Checks

1. Ensure the machine is clean and labeled with “CLEANED” status tag.
2. Verify the availability of the approved Batch Manufacturing Record (BMR).
3. Check the line clearance and ensure the area is free from previous product residues.
4. Verify the calibration and validation status of the filling machine.
5. Ensure HEPA filter airflow and environmental conditions meet Class 100/ISO 5 standards.

5.2 Machine Setup

1. Install the filling needles, peristaltic pump tubing, and sensors as per equipment configuration.
2. Adjust the filling speed, volume, dwell time, and nozzle height as per the batch-specific requirements.
3. Secure vial/syringe nests or conveyor alignment according to container format.
4. Record all setup parameters in the Equipment Setup Log (Annexure-1).

5.3 Operation

1. Switch ON the machine and run a dry cycle for 10 seconds to confirm smooth operation.
2. Load the sterile injectable solution under LAF in aseptic conditions.
3. Begin the fill operation with initial 10 vials as trial run. Verify volume accuracy with digital scale.
4. Start production fill cycle once QA confirms trial batch.
5. Maintain visual inspection of fill level, drips, and machine performance continuously.
6. In case of vial jam, leakage, or misfill, press emergency stop and resolve with QA intimation.

5.4 Post-Fill Activity

1. Remove all unused materials from the filling area.
2. Print and attach “Filling Completed” status label to machine.
3. Clean the machine as per SOP for cleaning and record the activity.
4. Document fill weight results and line stoppages in the Filling Log (Annexure-2).

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• LAF: Laminar Airflow

7. Documents

1. Equipment Setup Log – Annexure-1
2. Filling Operation Log – Annexure-2
3. Machine Cleaning Checklist – Annexure-3

8. References

• WHO TRS 961 – Annex 6: GMP for Sterile Pharmaceutical Products
• EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
• ICH Q9 – Quality Risk Management

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: Equipment Setup Log

Date	Batch No.	Volume Set	Speed	Operator
18/06/2025	IV-2045	5.0 mL	60 bpm	Rajesh Kumar

Annexure-2: Filling Operation Log

Time	Start Count	End Count	Observations	Checked By
10:00	0000	0500	Normal Operation	Sunita Reddy

Annexure-3: Machine Cleaning Checklist

Step	Activity	Done By	Date	Remarks
1	Wipe filling nozzles with 70% IPA	Ajay Verma	18/06/2025	Done

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
05/01/2022	1.0	Initial Issue	New SOP	QA Head
18/06/2025	2.0	Updated procedure steps and annexures	Periodic Review	QA Head