Operational Qualification Protocol for Fitz Mill in Solid Dosage Form Production

Objective: To validate the operational performance of the Fitz Mill in the production of solid dosage forms by verifying critical parameters and ensuring compliance with established acceptance criteria.

Scope: This protocol applies to the operational qualification of the Fitz Mill used for size reduction in the production area.

Responsibilities:

• Validation Team: Execute the protocol and document results.
• Quality Assurance: Review and approve the protocol and final report.
• Production Personnel: Ensure equipment is set up and maintained as per standard operating procedures.

Prerequisites:

• Completion of Installation Qualification (IQ).
• Training of personnel on Fitz Mill operation.
• Availability of necessary documentation (URS, SOPs, etc.).

Equipment Description: The Fitz Mill, also known as a Comminuting Mill, is designed for size reduction of materials in the production of solid dosage forms. It operates by utilizing a high-speed rotating blade to achieve the desired particle size distribution (PSD).

Detailed Test Cases:

• Test Case OQ-001:
  • Procedure: Set the Fitz Mill to the specified speed as per the URS.
  • Acceptance Criteria: Speed should be within the defined limits in the URS.
  • Evidence: Document speed settings and calibration results.
• Test Case OQ-002:
  • Procedure: Conduct a particle size analysis of the output material using appropriate testing methods.
  • Acceptance Criteria: Particle size distribution should conform to the URS requirements.
  • Evidence: Provide PSD analysis report, including raw data and analysis methods used.

Deviations: Any deviations from the established acceptance criteria must be documented and justified. A formal deviation report should be created and submitted for review.

Approvals:

• Prepared by: ____________________ Date: ___________
• Reviewed by: ____________________ Date: ___________
• Approved by: ____________________ Date: ___________