Document Control
Document Number: PQ-PM-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Performance Qualification Protocol for Pin Mill in Solid Dosage Form Production
Meta Description: This document outlines the Performance Qualification Protocol for the Pin Mill used in the production of Solid Dosage Forms, detailing objectives, scope, and test plans.
Tags: Performance Qualification, Equipment Validation, Pin Mill, Solid Dosage Form, Pharmaceutical Manufacturing
Objective
The objective of this Performance Qualification (PQ) protocol is to ensure that the Pin Mill operates consistently and reliably within predetermined specifications to produce solid dosage forms.
Scope
This protocol applies to the Performance Qualification of the Pin Mill used in the Production/Milling area for fine milling of solid dosage forms.
Responsibilities
The following responsibilities are assigned:
- Validation Team: Prepare and execute the PQ protocol.
- Quality Assurance: Review and approve the PQ protocol and results.
- Production Team: Provide operational support during testing.
Prerequisites
- Installation Qualification (IQ) completed and approved.
- Operational Qualification (OQ) completed and approved.
- Personnel trained on the Pin Mill operation.
Equipment Description
The Pin Mill is a mechanical device used for fine milling of solid dosage forms. It utilizes a pair of rotating discs to achieve the desired particle size distribution (PSD) through impact and shear forces.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TP-01 | Measure disc speed during operation. | Disc speed within specified range as per URS. | Calibration report and operational log. |
| TP-02 | Assess output PSD. | PSD meets specifications detailed in URS. | Particle size analysis report. |
| TP-03 | Monitor temperature during milling. | Temperature remains within acceptable limits as per URS. | Temperature log during operation. |
Detailed Test Cases
Test Case 1: Disc Speed Measurement
Procedure: Measure the disc speed using a calibrated tachometer during normal operation.
Acceptance Criteria: The disc speed must be within the range specified in the URS.
Evidence: Record the measurements in the logbook and attach the calibration certificate.
Test Case 2: Output PSD Assessment
Procedure: Collect samples of the milled product and perform particle size analysis using a laser diffraction method.
Acceptance Criteria: The PSD must meet the specifications outlined in the URS.
Evidence: Attach the particle size analysis report to the protocol.
Test Case 3: Temperature Monitoring
Procedure: Continuously monitor the temperature of the milling chamber during operation.
Acceptance Criteria: The temperature must remain within the limits specified in the URS.
Evidence: Log temperature readings and attach them to the protocol.
Deviations
Any deviations from the established protocols must be documented and justified. A deviation report should be submitted to Quality Assurance for review.
Approvals
This protocol must be approved by the following individuals:
- Validation Manager: ____________________ Date: ____________
- Quality Assurance Manager: _______________ Date: ____________