Performance Qualification Protocol for High Shear Granulator (HSG)

Document Control:

Document Number: PQ-HSG-001

Version: 1.0

Date: [Insert Date]

Prepared by: [Insert Name]

Reviewed by: [Insert Name]

Approved by: [Insert Name]

Objective

The objective of this Performance Qualification (PQ) protocol is to establish that the High Shear Granulator (HSG) operates consistently and reliably within predefined parameters during the wet granulation process, ensuring product quality and compliance with regulatory requirements.

Scope

This protocol applies to the High Shear Granulator (HSG) used in the production area for the wet granulation of solid dosage forms. It encompasses the qualification of equipment and processes to ensure direct product impact and criticality.

Responsibilities

The following personnel are responsible for the execution and oversight of this protocol:

• Validation Team: Responsible for protocol execution and data collection.
• Quality Assurance: Responsible for review and approval of the protocol and results.
• Production Team: Responsible for operating the HSG and documenting the process.

Prerequisites

• Completion of Installation Qualification (IQ) for HSG.
• Training of personnel on HSG operation.
• Availability of all necessary materials and resources.

Equipment Description

The High Shear Granulator (HSG) is designed for wet granulation processes, providing efficient mixing and granulation of powders. Key features include:

• Speed control for optimal mixing.
• Torque measurement for process validation.
• PLC integration for automated operations.

Test Plan

Detailed Test Cases

Test Case 1: Speed Verification

• Procedure: Set the HSG to the specified speed and record the actual speed.
• Acceptance Criteria: Speed must be within the specified range.
• Evidence: Calibration logs to be attached.

Test Case 2: Time Monitoring

• Procedure: Start the granulation process and record the time taken.
• Acceptance Criteria: Time must not exceed the predefined limit.
• Evidence: Batch records to be attached.

Test Case 3: Torque Measurement

• Procedure: Monitor and record torque during granulation.
• Acceptance Criteria: Torque readings must be consistent with URS Annex11.
• Evidence: Torque measurement logs to be attached.

Test Case 4: Binder Addition

• Procedure: Add binder according to the protocol and document the process.
• Acceptance Criteria: Binder must be added within the specified time frame and quantity.
• Evidence: Batch records to be attached.

Deviations

Any deviations from the protocol must be documented and justified. A deviation report must be submitted for review and approval.

Approvals

This protocol must be approved by the following personnel:

• Validation Manager: ______________________ Date: __________
• Quality Assurance: ______________________ Date: __________
• Production Manager: ______________________ Date: __________

Data Integrity Checks

• Ensure all data is recorded in real-time during the granulation process.
• Review logs for consistency and completeness.
• Implement electronic signatures for all critical documentation.