Document Control Number: PQ-OSD-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Performance Qualification Protocol for Co-Mill / Conical Mill in Solid Dosage Form Production
Objective: To validate the performance of the Co-Mill / Conical Mill to ensure its capability to meet defined specifications for de-agglomeration and sizing of solid dosage forms.
Scope: This protocol applies to the performance qualification of the Co-Mill / Conical Mill used in the production area for solid dosage forms. It details the necessary steps to ensure the equipment operates within specified parameters.
Responsibilities:
- Validation Team: Execute and document the PQ protocol.
- Production Team: Provide access to the equipment and assist in test execution.
- Quality Assurance: Review and approve the PQ documentation.
Prerequisites:
- Equipment installation qualification (IQ) must be completed.
- Standard operating procedures (SOPs) for equipment operation must be available.
- Personnel must be trained on equipment use and safety procedures.
Equipment Description: The Co-Mill / Conical Mill is designed for de-agglomeration and sizing of solid dosage forms. It operates using an impeller and screen system to achieve desired particle size distribution (PSD).
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Measure impeller speed at maximum load. | Impeller speed must be within specified range as per URS. | Calibration report, speed measurement logs. |
| PQ-02 | Evaluate screen size impact on output PSD. | Output PSD must meet specifications outlined in URS. | PSD analysis report, screen size documentation. |
| PQ-03 | Assess output product quality post-milling. | Product must meet established quality criteria. | Quality control test results, product samples. |
Detailed Test Cases:
- Test Case 1: Verify impeller speed at different settings to ensure compliance with URS.
- Test Case 2: Test various screen sizes and document the resultant PSD to confirm that it meets product specifications.
- Test Case 3: Collect samples of the milled product and conduct quality testing to ensure it adheres to standards.
Deviations: Any deviations from the acceptance criteria must be documented, investigated, and resolved prior to final approval of the PQ protocol.
Approvals:
- ____________________ (Validation Team Lead)
- ____________________ (Production Manager)
- ____________________ (Quality Assurance Manager)