compliance.

2. Scope

This SOP applies to all machines involved in sterile manufacturing including filling machines, lyophilizers, autoclaves, inspection machines, capping equipment, and auxiliary utilities used during injectable production.

3. Responsibilities

• Machine Operator: Perform machine operation as per validated procedures and GMP principles.
• Production Supervisor: Ensure machine readiness and adherence to GMP requirements.
• QA Personnel: Perform routine checks and verify GMP compliance documentation.

4. Accountability

The Production Manager is accountable for compliance to GMP in machine operations. The QA Manager ensures oversight and timely audit verification.

5. Procedure

5.1 Pre-Operation Checks

1. Ensure the area is clean and all surfaces are disinfected per the Area Cleaning SOP.
2. Verify the line clearance from QA is completed and recorded before starting operations.
3. Check machine calibration status, cleanliness, and pre-use inspection checklist (Annexure-1).

5.2 Equipment Setup and Operation

1. Follow validated procedures for assembling machine components using sterile tools and gloves.
2. Use SOP-defined machine settings and parameters verified during qualification.
3. Start the machine and verify:
   • Alarms and safety interlocks
   • Lubrication levels (where applicable)
   • Visual and mechanical function

5.3 GMP Operational Practices

1. Do not make unauthorized changes to machine settings.
2. Maintain hygienic practices: gowning, no jewelry, no makeup in cleanrooms.
3. Use only approved and qualified tools and utilities.
4. Avoid touching sterile surfaces; handle components with sterile gloves.
5. Ensure continuous documentation of critical process steps in logbooks.

5.4 Monitoring During Operation

1. Continuously observe for:
   • Abnormal vibration or noise
   • Rejects or fill weight deviations
   • Sealing, capping, or labeling defects
2. Perform hourly in-process checks and record in Annexure-2: GMP Operation Log.
3. Report any abnormality immediately and raise deviation report if required.

5.5 Post-Operation Requirements

1. Clean equipment as per Cleaning SOP and document in the Equipment Cleaning Log.
2. Ensure status labeling (Cleaned, To be Cleaned, Under Maintenance).
3. Close daily logbooks with signatures and submit for QA review.

5.6 Audit and GMP Compliance Checks

1. QA to perform GMP walkthroughs at least once per shift.
2. All non-conformances must be logged, evaluated, and closed with corrective actions.
3. Record all audit observations in Annexure-3: GMP Compliance Checklist.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practices
• QA: Quality Assurance
• CAPA: Corrective and Preventive Action

7. Documents

1. Machine Pre-Use Inspection Checklist – Annexure-1
2. GMP Operation Log – Annexure-2
3. GMP Compliance Checklist – Annexure-3

8. References

• WHO TRS 986 Annex 2 – GMP Guidelines for Sterile Pharmaceutical Products
• ICH Q10 – Pharmaceutical Quality System
• EU-GMP Guidelines – Part I Chapter 5

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: Machine Pre-Use Inspection Checklist

Machine	Checklist Item	Status	Remarks
Filler	Calibrated & Clean	OK
Lyophilizer	Door Lock Verification	OK	Secure

Annexure-2: GMP Operation Log

Date	Machine	Observation	Operator	Remarks
24/06/2025	Sealer	Cap Pressure Verified	Rajesh Kumar	Acceptable

Annexure-3: GMP Compliance Checklist

Date	Area	Checklist Item	Compliance	QA Auditor
24/06/2025	Filling Room	Operator Gowning	Yes	Sunita Reddy

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial release	New SOP	QA Head
24/06/2025	2.0	Updated annexures and compliance structure	Periodic Review	QA Head