Design Qualification Protocol for the Roller Compactor in Dry Granulation

Objective

The objective of this Design Qualification (DQ) protocol is to verify that the Roller Compactor meets the specified requirements for its intended use in the Dry Granulation process of Solid Dosage Forms, ensuring compliance with regulatory standards and operational functionality.

Scope

This protocol applies to the Roller Compactor utilized in the Production area for Dry Granulation of Solid Dosage Forms. It encompasses the validation of critical parameters and compliance with the User Requirements Specification (URS) and Annex 11.

Responsibilities

• Validation Team: Responsible for executing the DQ protocol and documenting results.
• Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
• Production Team: Responsible for providing operational input and support during the DQ process.

Prerequisites

• Completion of Installation Qualification (IQ) for the Roller Compactor.
• Availability of User Requirements Specification (URS) and Annex 11 documentation.
• Training of personnel on the operation and maintenance of the Roller Compactor.

Equipment Description

The Roller Compactor is a critical piece of equipment used in the Dry Granulation process. It applies pressure to powder mixtures to form granules, enhancing flowability and compressibility for subsequent processing. Key features include:

• Roll pressure control
• Gap adjustment
• Speed control
• PLC integration for process monitoring

Test Plan

Detailed Test Cases

Test Case T1: Verify Roll Pressure Settings

Procedure: Adjust the roll pressure to the specified setting and record the actual value. Compare it against the URS.

Expected Outcome: The actual roll pressure should be within the specified range as per the URS.

Test Case T2: Check Gap Settings

Procedure: Measure the gap between the rolls using a calibrated gauge and compare it to the specifications.

Expected Outcome: The gap measurement should align with the specifications outlined in the URS.

Test Case T3: Test Speed Settings

Procedure: Set the Roller Compactor to the designated speed and ensure it operates within the specified range.

Expected Outcome: The speed should remain within operational limits during the test.

Test Case T4: Validate Feed Rate

Procedure: Measure the feed rate during operation and compare it to the URS requirements.

Expected Outcome: The feed rate should match the specifications outlined in the URS.

Deviations

Any deviations from the acceptance criteria must be documented and assessed for impact on the validation process. Corrective actions should be identified and implemented as necessary.

Approvals

This Design Qualification Protocol must be reviewed and approved by the Quality Assurance team and relevant stakeholders prior to execution.