Performance Qualification Protocol for Oscillating Granulator
Document Control Number: PQ-OSD-OG-001
Version: 1.0
Effective Date: YYYY-MM-DD
Reviewed By: [Name]
Approved By: [Name]
Objective: To validate the performance of the Oscillating Granulator to ensure it meets the specified requirements for size reduction of wet/dry mass in the production of solid dosage forms.
Scope: This protocol applies to the Oscillating Granulator used in the production area for solid dosage forms, focusing on critical parameters impacting product quality.
Responsibilities:
- Validation Team: Execute the protocol and document results.
- Quality Assurance: Review and approve the validation documentation.
- Production Personnel: Operate the equipment as per the protocol requirements.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Training of personnel on the use of the Oscillating Granulator.
Equipment Description: The Oscillating Granulator is a piece of equipment used for the size reduction of wet and dry masses in the production of solid dosage forms. It operates by oscillating a screen to achieve the desired particle size distribution (PSD).
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Verify speed settings during operation. | Speed must be within specified range as per URS. | Calibration logs and operational records. |
| PQ-02 | Check screen size used for granulation. | Screen size must match specifications outlined in URS. | Screen specifications and visual inspection. |
| PQ-03 | Assess output particle size distribution (PSD). | Output PSD must conform to specifications detailed in URS. | PSD analysis report. |
Detailed Test Cases:
- Test Case PQ-01: Operate the granulator at specified speeds and document the readings. Ensure that the speed remains within the acceptable range.
- Test Case PQ-02: Inspect the installed screen size and verify against the specifications. Document any discrepancies.
- Test Case PQ-03: Collect samples of granulated material and perform PSD analysis. Compare results to the acceptance criteria.
Deviations: Any deviations from the acceptance criteria must be documented and justified. A deviation report should be submitted to Quality Assurance for review.
Approvals:
- _____________________
[Name]
Validation Team Lead - _____________________
[Name]
Quality Assurance