applies to all sterile injectable manufacturing machines, including filling machines, lyophilizers, autoclaves, vial washers, and packaging lines where critical parameters must be controlled to ensure process reliability.

3. Responsibilities

• Machine Operator: Monitor CCPs as per SOP and record in relevant logs.
• Production Supervisor: Verify compliance, escalate deviations, and ensure real-time corrective action.
• QA Officer: Review records and confirm corrective/preventive actions for non-conformities.

4. Accountability

The Head of Production is accountable for implementation and compliance with this SOP, while the QA Head ensures oversight and approval.

5. Procedure

5.1 Identification of Critical Control Points

1. Review the machine’s process flow diagram and identify stages where deviations may impact:
   • Product sterility
   • Filling accuracy
   • Sealing integrity
   • Equipment sterilization
2. Document the identified CCPs in the CCP Register (Annexure-1).

5.2 List of Common CCPs in Injectable Manufacturing

• Temperature and pressure in autoclaves
• Filling volume variation in vial and syringe filling machines
• Sealing force and crimp integrity
• HEPA filter airflow and cleanliness status in LAFs
• Vial washing pressure and WFI temperature
• Vacuum hold in lyophilizers during sublimation phase

5.3 Monitoring Frequency and Parameters

1. Operators must monitor parameters per batch or at defined intervals (e.g., hourly).
2. Use calibrated instruments or built-in system readouts.
3. Record readings in Machine CCP Monitoring Log (Annexure-2).

5.4 Handling Deviations in CCPs

1. Immediately pause the operation if CCP deviation is observed.
2. Inform Production Supervisor and QA for joint assessment.
3. Initiate deviation report and conduct impact assessment for affected product (Annexure-3).
4. Resume operations only after corrective action is implemented and authorized.

5.5 Preventive Maintenance and Verification

1. Perform preventive maintenance of machines as per equipment SOPs.
2. Verify CCP instrument calibration status before batch start-up.
3. Conduct mock failure drills during training sessions.

5.6 Documentation and Review

1. All CCP monitoring data must be reviewed daily by production supervision.
2. QA must audit CCP records weekly and during batch release.
3. Retain CCP logs as GMP records for at least 5 years.

6. Abbreviations

• SOP: Standard Operating Procedure
• CCP: Critical Control Point
• QA: Quality Assurance
• LAF: Laminar Air Flow
• WFI: Water for Injection

7. Documents

1. CCP Register – Annexure-1
2. Machine CCP Monitoring Log – Annexure-2
3. Deviation Assessment and CAPA Form – Annexure-3

8. References

• ICH Q10 – Pharmaceutical Quality System
• WHO Technical Report Series No. 986
• EU GMP Annex 1 (2022)

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: CCP Register

Machine	CCP	Parameter	Limit	Monitoring Frequency
Filling Machine	Filling Volume	Volume (mL)	±2%	Every hour

Annexure-2: Machine CCP Monitoring Log

Date	Machine	CCP	Value Observed	Operator	Remarks
24/06/2025	Vial Filler	Filling Volume	2.99 mL	Sunita Reddy	Within limit

Annexure-3: Deviation Assessment and CAPA Form

Date	Deviation	Root Cause	Corrective Action	Preventive Action	QA Verified
23/06/2025	Overfill Detected	Sensor Drift	Re-calibrated	Quarterly sensor check	Yes

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial version	New SOP	QA Head
24/06/2025	2.0	Updated annexures and scope	Annual Review	QA Head