Flake Crusher (Post-Roller Compaction) – PQ Protocol

Document Control

Document Number: PQ-FC-001

Version: 1.0

Effective Date: [Insert Date]

Reviewed by: [Insert Reviewer Name]

Approval Date: [Insert Approval Date]

Performance Qualification Protocol for Flake Crusher in Solid Dosage Form Production

Objective

The objective of this Performance Qualification (PQ) protocol is to verify that the Flake Crusher operates according to the specified requirements and meets the acceptance criteria outlined in the User Requirement Specification (URS).

Scope

This protocol applies to the Flake Crusher used in the production area for dry granulation processes. It covers the testing of the equipment to ensure it meets the defined critical parameters.

Responsibilities

  • Validation Team: Responsible for executing the PQ protocol and documenting results.
  • Quality Assurance: Responsible for reviewing and approving the PQ documentation.
  • Production Team: Responsible for providing access to the equipment and supporting the validation activities.

Prerequisites

  • Completion of Installation Qualification (IQ) and Operational Qualification (OQ) for the Flake Crusher.
  • Availability of the necessary materials for testing.
  • Training of personnel on the operation of the Flake Crusher.

Equipment Description

The Flake Crusher is designed to crush ribbons/flakes generated from the roller compaction process. It operates within the production area and is critical for ensuring uniform particle size distribution necessary for subsequent processing steps.

Test Plan

Test ID Procedure Acceptance Criteria Evidence
TP-01 Measure the speed of the Flake Crusher during operation. Speed must be within the range specified in the URS. Calibration report and log of speed measurements.
TP-02 Evaluate the screen output particle size distribution (PSD). PSD must meet the specifications outlined in the URS. Particle size analysis report.
See also  Binder Solution Preparation Tank – OQ Protocol

Detailed Test Cases

Test Case 1: Speed Measurement

Procedure: Operate the Flake Crusher and record the speed using a calibrated tachometer.

Acceptance Criteria: Speed must be within the range specified in the URS.

Evidence: Speed logs and calibration certificates.

Test Case 2: Particle Size Distribution Analysis

Procedure: Collect samples of crushed material and analyze using a laser diffraction particle size analyzer.

Acceptance Criteria: The PSD must be within the specifications outlined in the URS.

Evidence: PSD analysis report.

Deviations

Any deviations from the protocol must be documented, including the reason for the deviation and the corrective actions taken. All deviations require approval from the Quality Assurance team.

Approvals

Prepared by: [Insert Name] – [Insert Title]

Approved by: [Insert Name] – [Insert Title]

“`

Also Check:

Vacuum Transfer System (Mobile) – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Vacuum Transfer System (Mobile) Subcategory: Solid Dosage Form (OSD) Area: Production/Material Transfer Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifier: [Equipment Identifier] Protocol Reference: [Protocol Reference] Execution Dates: [Execution…

Centrifugal Sifter – OQ Protocol

Document Control: Document Number: OQ-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Prepared by: [Insert Name] Approved by: [Insert Name] Operational Qualification Protocol for the Centrifugal Sifter Objective: To validate the operational performance of the Centrifugal Sifter…

Weighing Balance (Platform/Floor) – DQ Protocol

Document Number: DQ-OSD-WB-001 Version: 1.0 Effective Date: 2023-10-01 Review Date: 2024-10-01 Prepared By: [Your Name] Approved By: [Approver’s Name] Design Qualification Protocol for Weighing Balance in Solid Dosage Form Objective: To establish a Design Qualification (DQ) protocol for the Weighing…