overseeing the identification and resolution of process variations, ensuring that corrective and preventive actions (CAPA) are implemented and documented according to GMP standards.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed and that process variations are properly identified and addressed. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Identifying Process Variations

1. Monitor the production process at each stage to detect any variations from the established process parameters. Variations can include, but are not limited to:
   • Inconsistent product quality (e.g., color, viscosity, weight)
   • Equipment performance issues (e.g., incorrect speed, temperature fluctuations)
   • Variation in raw material quality
   • Environmental conditions affecting the manufacturing process
2. Operators should use process control charts, monitoring systems, and visual inspections to identify process variations.
3. In case of any deviation from the expected results, operators should stop the process and report the variation to the team leader or supervisor for further action.

5.2. Documenting Process Variations

1. Once a variation is detected, document the issue immediately in the Process Variation Report (Annexure-1). The report should include:
   • The type of variation detected
   • Batch number
   • Time and date of occurrence
   • Person(s) involved
   • Initial corrective action taken
2. Ensure that the variation report is signed by the operator and team leader before it is forwarded to the Quality Control (QC) and Quality Assurance (QA) teams for investigation.

5.3. Investigating Process Variations

1. The QC team, along with the production and maintenance teams, should conduct an investigation to identify the root cause of the process variation. Investigate the following areas:
   • Review of equipment settings and maintenance logs
   • Analysis of raw material quality and batch records
   • Environmental factors such as temperature, humidity, and airflow
   • Operator training and adherence to SOPs
2. The investigation should be documented in the Process Variation Investigation Report (Annexure-2), including all findings, potential causes, and contributing factors.
3. During the investigation, if the root cause is not immediately clear, implement additional testing, root cause analysis, or consult with relevant departments (e.g., R&D, equipment suppliers).

5.4. Corrective and Preventive Actions (CAPA)

1. Once the root cause of the process variation is identified, develop and implement corrective actions to address the issue. Corrective actions may include:
   • Adjustments to equipment settings or recalibration
   • Retraining of operators or process requalification
   • Changes to raw material specifications or handling procedures
   • Environmental controls to maintain stable conditions
2. Implement preventive actions to ensure that similar variations do not occur in the future. Preventive actions may include:
   • Revisions to SOPs or work instructions
   • Installation of automated monitoring systems or alarms
   • Periodic preventive maintenance schedules for equipment
3. Document all corrective and preventive actions in the Corrective Action and Preventive Action (CAPA) Log (Annexure-3). Include details of the action, the responsible person, the timeline, and verification steps.

5.5. Verification of Corrective Actions

1. Once corrective and preventive actions are implemented, monitor the process closely to verify that the actions have resolved the issue and that similar variations do not recur.
2. Conduct follow-up inspections, testing, and analysis to ensure the effectiveness of the corrective and preventive actions.
3. Record the results of the verification process in the CAPA Follow-Up Report (Annexure-4). If the corrective actions are effective, close the deviation report. If the issue persists, revisit the investigation and CAPA steps.

5.6. Documentation and Record-Keeping

1. Ensure that all documentation related to process variations, investigations, and corrective actions is complete, accurate, and securely stored according to the company’s document retention policy.
2. Ensure that records are available for internal and external audits and regulatory inspections.
3. Review the documentation regularly to ensure compliance with GMP guidelines and company policies.

6. Abbreviations

• GMP: Good Manufacturing Practice
• CAPA: Corrective and Preventive Actions
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure

7. Documents

1. Process Variation Report (Annexure-1)
2. Process Variation Investigation Report (Annexure-2)
3. CAPA Log (Annexure-3)
4. CAPA Follow-Up Report (Annexure-4)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems
• International Pharmacopoeia (Ph. Int.) – Aerosol Delivery

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Process Variation Report

Batch No.	Variation Description	Initial Action Taken	Operator Name	Time
12345	Temperature variation	Adjusted heater settings	Rajesh Patel	06/02/2025

Annexure-2: Process Variation Investigation Report

Batch No.	Investigation Findings	Root Cause	Corrective Actions	Responsible Person
12345	Heater malfunction	Electrical fault	Replaced faulty components	Rajesh Patel

Annexure-3: CAPA Log

Batch No.	Corrective Action	Preventive Action	Completion Date	Responsible Person
12345	Replaced heater components	Periodic equipment checks	06/02/2025	Rajesh Patel

Annexure-4: CAPA Follow-Up Report

Batch No.	Follow-Up Actions	Verification Results	Operator Name
12345	Verified equipment functionality	No recurrence	Rajesh Patel

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated process variation procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures