Standard Operating Procedure for Monitoring Critical Process Parameters (CPPs)

Department	Tablet
SOP No.	SOP/TAB/196/2025
Supersedes	SOP/TAB/196/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To define the process for monitoring Critical Process Parameters (CPPs) during tablet manufacturing to ensure that processes remain within defined limits and meet product quality specifications.

2. Scope

This SOP applies to the monitoring of all Critical Process Parameters (CPPs) during the tablet manufacturing process, including granulation, compression, coating, and packaging, ensuring that the product is manufactured consistently within specified quality standards.

3. Responsibilities

• Production Team: Responsible for monitoring CPPs during tablet manufacturing and recording data for each batch.
• Quality Control (QC): Responsible for reviewing and validating CPP data, ensuring that the process remains in control and meets the acceptance criteria.
• Quality Assurance (QA): Responsible for ensuring that CPP monitoring is performed according to the established SOPs, conducting audits, and reviewing data for regulatory compliance.
• Engineering Team: Responsible for maintaining and calibrating equipment used to monitor CPPs to ensure accurate measurements.

4. Accountability

The QA Manager is accountable for ensuring that this SOP is followed and that CPP monitoring is performed properly. The Production Manager is responsible for ensuring that the correct CPPs are monitored and documented during tablet manufacturing.

5. Procedure

5.1 Identification of Critical Process Parameters (CPPs)

1. Identify CPPs based on their impact on the product quality and the manufacturing process. These may include parameters such as temperature, pressure, mixing time, and compression force.
2. CPPs should be defined for each stage of tablet manufacturing (e.g., granulation, compression, coating) and must be documented in the batch manufacturing record.
3. Review historical data, regulatory guidelines, and product specifications to identify which parameters are critical for maintaining product quality and process stability.

5.2 Monitoring of CPPs

1. Monitor the identified CPPs at specified intervals throughout the manufacturing process, ensuring that they remain within the predefined limits.
2. Use calibrated equipment to measure CPPs, ensuring accuracy and consistency of data collected during the process.
3. Document all CPP measurements, including time, value, and operator, in the appropriate batch records or monitoring logs (Annexure-1).
4. Monitor trends in CPPs to identify any variations that could indicate potential issues with the process.

5.3 In-Process Adjustments

1. If a CPP deviates from its specified limits, immediately investigate the cause of the variation.
2. Make necessary adjustments to bring the process back within control. This may include adjusting equipment settings, changing materials, or altering process conditions.
3. Ensure that any adjustments made are documented and that they comply with the approved process parameters (Annexure-2).

5.4 Review of CPP Data

1. At the end of each production run, review all CPP data to ensure that the process has remained within control limits and that the product meets the required quality attributes.
2. Any deviations or out-of-specification results should be investigated, and corrective actions should be implemented as necessary. These actions should be documented and tracked (Annexure-3).
3. The QC team should validate the CPP data and approve the batch for release or take action if the process was not in control.

5.5 Documentation and Record Keeping

1. Ensure that all CPP monitoring data, including measurements, trends, deviations, and corrective actions, are accurately documented and filed for each batch.
2. Maintain records of CPP monitoring logs for regulatory inspections and audits. These records should be retained for the required duration (e.g., five years) (Annexure-4).
3. Ensure that CPP data is easily accessible and stored in a manner that allows for quick retrieval during investigations or audits.

5.6 Equipment Calibration

1. Ensure that all equipment used to measure CPPs is calibrated according to the manufacturer’s specifications and company procedures.
2. Document all calibration activities, including the date of calibration, equipment used, and results, to ensure traceability (Annexure-5).

5.7 Review and Continuous Improvement

1. At regular intervals, review the CPP monitoring process to identify opportunities for improvement.
2. Assess whether additional CPPs should be monitored or if current monitoring processes need adjustments based on trends, feedback, or changes in regulations.
3. Implement improvements and update the monitoring plan accordingly. Document all changes in the procedure and communicate them to relevant personnel.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• GMP: Good Manufacturing Practice
• CPP: Critical Process Parameter

7. Documents

1. CPP Monitoring Log (Annexure-1)
2. In-Process Adjustment Log (Annexure-2)
3. Corrective Action Report (Annexure-3)
4. Equipment Calibration Record (Annexure-4)
5. CPP Data Review Report (Annexure-5)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• ISO 9001 – Quality Management Systems
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

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 Monitoring Log

Batch Number	CPP Parameter	Value	Time	Operator
Batch-12345	Compression Force	50 kN	12:00 PM	John Doe

Annexure-2: In-Process Adjustment Log

Batch Number	Adjustment Made	Reason for Adjustment	Operator	Time of Adjustment
Batch-12345	Increased compression force	To maintain tablet hardness	Jane Smith	12:10 PM

Annexure-3: Corrective Action Report

Action ID	Issue	Corrective Action	Completion Date
CAPA-001	Deviation in compression force	Re-calibrated tablet press	01/04/2026

Annexure-4: Equipment Calibration Record

Equipment Name	Calibration Date	Calibration Due Date	Calibration Result	Calibrated By
Tablet Press	01/02/2026	01/08/2026	Pass	John Doe

Annexure-5: CPP Data Review Report

Batch Number	CPP Parameter	Reviewed By	Comments	Status
Batch-12345	Compression Force	Jane Smith	All parameters are within the limit	Approved

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated CPP parameters	Process improvements	QA Head