GMP standards and operational excellence.

2. Scope

This SOP is applicable to all sterile injectable filling lines within the manufacturing facility. It covers the monitoring of line speed, filling accuracy, reject rate, equipment alarms, line stoppages, and key process metrics during routine production operations.

3. Responsibilities

• Machine Operators: Continuously monitor HMI screens, fill volumes, and alert supervisors of any anomalies.
• Production Supervisors: Analyze real-time data and implement minor corrections. Maintain production logs.
• Quality Assurance (QA): Review process parameters and deviations. Conduct spot checks.
• Engineering: Maintain SCADA systems, handle alarms, calibrate sensors, and conduct diagnostics.

4. Accountability

The Production Manager is accountable for ensuring that real-time filling line monitoring is operational, documented, and integrated with corrective action protocols.

5. Procedure

5.1 System Requirements

1. Ensure SCADA/HMI/PLC systems are operational and calibrated before initiating the batch.
2. Confirm all sensors and indicators (e.g., fill weight, temperature, volume sensors) are functioning.

5.2 Monitoring Parameters

1. Parameters to monitor:
   • Line speed (vials/minute or syringes/minute)
   • Fill weight or volume per unit
   • Rejection rate (%)
   • Downtime and cause
   • Number of interventions

5.3 Real-Time Display and Alerts

1. Monitor all data through HMI or SCADA displays mounted on the filling line.
2. Configure alerts for:
   • Fill volume deviation beyond ±2%
   • Reject rate >3%
   • Unexpected line stoppage >2 minutes
3. Log each alert in the Performance Monitoring Log (Annexure-1).

5.4 Documentation

1. Fill in hourly performance log:
   • Output per hour
   • Cumulative rejects
   • Line downtime duration
2. Attach printouts from SCADA systems for record-keeping.
3. Highlight anomalies and record actions taken.

5.5 Reconciliation and Review

1. At batch end, calculate:
   • Total units filled
   • Total rejects
   • Yield percentage
2. QA to review the logs, SCADA reports, and investigate any trend shifts or repeated issues.

5.6 Corrective and Preventive Action (CAPA)

1. If reject trends exceed target limits, initiate CAPA.
2. Include maintenance checks, training refreshers, or review of operating SOPs if necessary.

5.7 Handling Alarms and Stoppages

1. Operators must record all alarms and stoppages in the SCADA alarm summary log.
2. Post-intervention checks must be verified by QA before restarting the line.

6. Abbreviations

• SOP: Standard Operating Procedure
• SCADA: Supervisory Control and Data Acquisition
• HMI: Human-Machine Interface
• QA: Quality Assurance
• CAPA: Corrective and Preventive Action

7. Documents

1. Performance Monitoring Log – Annexure-1
2. Alarm Summary Log – Annexure-2
3. SCADA Summary Report – Annexure-3

8. References

• WHO GMP Guidelines
• ICH Q8 – Pharmaceutical Development
• 21 CFR Part 11 – Electronic Records and Signatures

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: Performance Monitoring Log

Time	Units Produced	Rejects	Downtime (min)	Remarks
10:00–11:00	1800	30	0	Normal
11:00–12:00	1750	42	5	Sensor misalignment

Annexure-2: Alarm Summary Log

Time	Alarm	Description	Resolved By	Action Taken
11:15	Volume Low	Filler nozzle clogged	Arjun Patel	Cleaned and flushed

Annexure-3: SCADA Summary Report

Time	Fill Volume (mL)	Speed (units/min)	Reject %
10:00	5.02	90	1.6%
11:00	4.96	88	2.4%

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/09/2022	1.0	Initial Release	New SOP	QA Head
24/06/2025	2.0	SCADA integration and alarm response updates	Periodic Review	QA Head