Standard Operating Procedure for Risk-Based Monitoring of Manufacturing Processes

Department	Tablet
SOP No.	SOP/TAB/216/2025
Supersedes	SOP/TAB/216/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

This SOP outlines the procedure for implementing risk-based monitoring during tablet manufacturing processes. The goal is to focus resources on critical process parameters (CPPs) and critical quality attributes (CQAs) to mitigate risks that could impact product quality, compliance, and patient safety.

2. Scope

This SOP applies to all tablet manufacturing processes where risk-based monitoring is required. It covers identifying critical process parameters, assessing associated risks, and setting up monitoring strategies to ensure that process deviations are promptly detected and controlled.

3. Responsibilities

• Quality Assurance (QA) Manager: Responsible for overseeing the implementation of risk-based monitoring, reviewing risk assessments, and ensuring compliance with this SOP.
• Production Manager: Responsible for identifying CPPs, implementing risk mitigation strategies, and ensuring the process is closely monitored during production.
• Quality Control (QC) Team: Responsible for providing input into the risk assessments, conducting necessary tests, and monitoring key quality attributes throughout production.
• Risk Management Team: Responsible for performing risk assessments, determining the level of risk, and implementing mitigation plans.

4. Accountability

The QA Manager is accountable for ensuring that risk-based monitoring is effectively implemented throughout the manufacturing process. The Production and QC teams are responsible for executing monitoring activities, while the Risk Management team is responsible for risk assessments and mitigation.

5. Procedure

5.1 Identifying Critical Process Parameters (CPPs)

1. Collaborate with the production and QC teams to identify the critical process parameters (CPPs) for each tablet manufacturing process (e.g., temperature, pressure, flow rate, etc.).
2. Evaluate the impact of each CPP on the final product quality to determine which parameters should be monitored more closely.
3. Document all identified CPPs, including justification for their criticality (Annexure-1).

5.2 Risk Assessment

1. Conduct a risk assessment to determine the likelihood and severity of risks associated with the identified CPPs and CQAs.
2. Utilize a risk matrix or other tools to categorize the risk level (e.g., high, medium, low) for each CPP (Annexure-2).
3. Prioritize monitoring efforts on high-risk areas to ensure that resources are allocated efficiently.
4. Document the risk assessment results and mitigation strategies (Annexure-3).

5.3 Monitoring Strategy Development

1. Develop a monitoring plan based on the identified risks and critical parameters. The plan should include:
   • Frequency of monitoring
   • Methods of monitoring (manual or automated)
   • Accepted control limits for each CPP and CQA
   • Corrective actions for deviations
2. Ensure that monitoring systems are in place to collect real-time data on the identified parameters (Annexure-4).
3. Communicate the monitoring plan to all relevant personnel involved in the production process.

5.4 Monitoring During Production

1. Implement the monitoring plan during tablet production, ensuring that critical parameters are regularly checked and recorded.
2. Monitor key process variables, such as mixing times, granulation temperature, tablet compression force, and coating thickness.
3. Immediately report any deviations outside of predefined acceptable limits to the QA Manager and the production team for corrective action.
4. Record all monitoring data for traceability and future audits (Annexure-5).

5.5 Corrective and Preventive Actions

1. If deviations are detected during the manufacturing process, initiate corrective actions to return the process to within acceptable limits.
2. Investigate the root cause of the deviation and implement preventive measures to avoid recurrence.
3. Document all corrective actions, preventive measures, and follow-up results (Annexure-6).

5.6 Documentation and Record Keeping

1. Ensure all risk assessments, monitoring plans, monitoring data, corrective actions, and preventive actions are fully documented and stored securely.
2. Retain all records for a minimum of 5 years or as required by regulatory standards (Annexure-7).

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• GMP: Good Manufacturing Practice
• CAPA: Corrective and Preventive Action
• CPP: Critical Process Parameter
• CQA: Critical Quality Attribute

7. Documents

1. Risk Assessment Documentation (Annexure-2)
2. Monitoring Plan (Annexure-4)
3. Corrective and Preventive Action Documentation (Annexure-6)
4. Monitoring Data (Annexure-5)
5. Risk Assessment and Monitoring Records (Annexure-7)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• ISO 9001 – Quality Management Systems
• ICH Q10 – Pharmaceutical Quality System

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: CPP Identification and Justification

CPP	Justification
Granulation Temperature	Impacts tablet hardness and dissolution rate

Annexure-2: Risk Assessment

Parameter	Risk Level (High/Medium/Low)	Mitigation Strategy
Tablet Compression Force	High	Continuous monitoring and control

Annexure-3: Risk Assessment Summary

Parameter	Risk Level	Monitoring Frequency
Tablet Disintegration Time	Medium	Twice per batch

Annexure-4: Monitoring Plan

CPP	Monitoring Method	Control Limits
Granulation Time	Manual Time Log	10-15 mins

Annexure-5: Monitoring Data

Parameter	Result	Pass/Fail
Tablet Hardness	7 kg	Pass

Annexure-6: Corrective and Preventive Actions

Issue	Corrective Action	Preventive Action
Granulation Temperature Out of Range	Calibrate temperature equipment	Increase frequency of calibration checks

Annexure-7: Risk-Based Monitoring Records

Batch Number	Parameter Monitored	Monitoring Result	Corrective Action Taken
Batch123	Granulation Temperature	Within Limits	None

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial SOP creation	New process	QA Head
01/02/2025	2.0	Added risk mitigation strategies	Annual review	QA Head