Performance Qualification Protocol for Roller Compactor in Solid Dosage Form

Objective

The objective of this Performance Qualification (PQ) protocol is to verify that the Roller Compactor operates according to defined specifications and meets the acceptance criteria outlined in the User Requirement Specification (URS) Annex 11.

Scope

This protocol applies to the Roller Compactor used in the production area for dry granulation of solid dosage forms (OSD). The qualification will cover the critical parameters impacting product quality.

Responsibilities

• Validation Team: Responsible for executing the PQ protocol and documenting results.
• Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
• Production Personnel: Responsible for providing access to the equipment and necessary operational support.

Prerequisites

• Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
• Training of personnel on the operation of the Roller Compactor.
• Availability of all necessary materials and equipment for testing.

Equipment Description

The Roller Compactor is designed for the dry granulation process, featuring adjustable roll pressure, gap settings, and PLC-controlled operational parameters. Key critical parameters include roll pressure, gap, speed, and feed rate.

Test Plan

Detailed Test Cases

Test Case: PQ-RC-01 – Verify Roll Pressure

Procedure: Set the roll pressure to the specified value and record the actual pressure. Compare with acceptance criteria.

Acceptance Criteria: Roll pressure must be within the limits defined in URS Annex 11.

Evidence: Calibration records and pressure readings.

Test Case: PQ-RC-02 – Check Gap Settings

Procedure: Measure the gap settings using a calibrated gauge. Document the measurements.

Acceptance Criteria: Gap settings must match specifications outlined in the URS.

Evidence: Measurement logs and calibration certificates.

Test Case: PQ-RC-03 – Assess Speed and Feed Rate

Procedure: Monitor the speed and feed rate during operation. Record the values.

Acceptance Criteria: Both parameters must be within the defined ranges.

Evidence: Operational logs and monitoring data.

Test Case: PQ-RC-04 – PLC Functionality Test

Procedure: Run the PLC through a series of operational tests to ensure functionality.

Acceptance Criteria: No errors should occur during operation.

Evidence: PLC test records and error logs.

Deviations

Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions must be implemented.

Approvals

Prepared by: ___________________ Date: ___________

Approved by: ___________________ Date: ___________

Data Integrity Checks

• Ensure all data recorded is time-stamped and attributed to the responsible personnel.
• Implement electronic signatures for critical parameters in the CSV system.
• Regular backup of data to prevent loss.