and ensuring that all documentation is correct and complete. QA will also review all deviations from in-process control standards.

Laboratory Supervisor: Responsible for ensuring that the risk-based in-process controls are identified and assessed for each batch. They must also ensure that any corrective actions required are taken in a timely manner.

4. Accountability

The Production Manager is accountable for ensuring that risk-based in-process controls are performed during the manufacturing process. The QA Manager is responsible for overseeing the risk management process and ensuring compliance with all relevant procedures. The QC Manager is accountable for the accuracy and completeness of in-process control records.

5. Procedure

5.1 Risk Assessment for In-Process Controls

1. Before the start of production, identify critical process parameters (CPPs) based on a risk assessment of the manufacturing process. CPPs include parameters that have the highest impact on the quality, safety, and efficacy of the cream product.
2. Perform a risk-based analysis to determine which parameters need to be monitored during production. This analysis should be based on factors such as product characteristics, raw material variability, and process complexities.
3. Document the identified CPPs and corresponding in-process control limits in the Batch Manufacturing Record (BMR) and ensure that the team is trained on these parameters.
4. Risk assessments should be reviewed regularly to ensure they remain relevant and up-to-date with any process or product changes.

5.2 Performing In-Process Control Monitoring

1. During production, continuously monitor and document the identified CPPs at specified intervals (e.g., temperature, pH, viscosity, etc.) as per the BMR instructions.
2. Use automated or manual systems to track the process parameters, ensuring that the readings are within the defined acceptable limits. If the parameters go beyond the acceptable range, stop the process immediately and take corrective actions.
3. For each parameter, ensure that the monitoring equipment is calibrated and functioning properly. Calibration should be performed according to the manufacturer’s recommendations and GMP guidelines.
4. Verify that any adjustments made to the process parameters are documented, including the reason for the adjustment and the corrective actions taken.

5.3 Handling Deviations from In-Process Control Limits

1. If an in-process control deviation occurs, stop the process immediately and investigate the cause. Deviations could include out-of-range pH levels, temperature fluctuations, or incorrect ingredient ratios.
2. Identify the root cause of the deviation and perform corrective actions. Corrective actions may include adjusting process parameters, recalibrating equipment, or reprocessing raw materials.
3. Once the issue is resolved, resume production and continue to monitor the parameters to ensure they remain within the acceptable range.
4. Document all deviations, corrective actions, and rework in the Deviation Report (Annexure-1) and ensure that the report is reviewed by the QA team.

5.4 Post-Production Activities

1. Once the production run is complete, review the in-process control records and verify that all CPPs were monitored, documented, and maintained within specified limits.
2. Ensure that all in-process control data is reviewed and approved by the QC team. The data should be stored in the batch record for future reference and audits.
3. If no deviations were recorded, approve the batch for the next stage (e.g., packaging, labeling). If deviations were recorded, review the corrective actions taken and verify that the product meets quality standards before moving forward.

5.5 Documentation and Record-Keeping

1. Document all in-process control activities in the Batch Manufacturing Record (BMR) and ensure that each parameter is logged correctly. The documentation should include time, operator details, and values observed for each critical parameter.
2. Record any deviations, corrective actions, and investigations in the Deviation Report (Annexure-1). This ensures that all issues are properly documented and addressed.
3. Ensure that all records are reviewed by the QC team for accuracy and completeness. Store all documentation for the required retention period (typically two years or as specified by local regulations).

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• CPP: Critical Process Parameter
• BMR: Batch Manufacturing Record
• PPE: Personal Protective Equipment

7. Documents

1. Annexure-1: Deviation Report
2. Annexure-2: In-Process Control Log

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• FDA Guidance for Industry: Process Control and Risk-Based Approaches in Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Deviation Report

Batch Number	Deviation Description	Corrective Action	Resolved By
12345	Temperature exceeded specified limit	Adjusted heating temperature, resumed production
12345	Temperature exceeded specified limit	Adjusted heating temperature, resumed production	Michael Lee

Annexure-2: In-Process Control Log

Batch Number	Time	Parameter	Measured Value	Operator	Remarks
12345	09:00 AM	pH	5.2	John Doe	Within specification
12345	09:30 AM	Viscosity	1200 cP	Jane Smith	Within specification
12345	10:00 AM	Temperature	80°C	Michael Lee	Above specification, corrective action taken

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head