Operational Qualification Protocol for Pin Mill in Solid Dosage Form
Document Number: OQ-PM-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Pin Mill operates according to defined specifications and meets the acceptance criteria as outlined in the User Requirement Specification (URS).
Scope
This protocol applies to the Pin Mill located in the Production/Milling area, utilized for fine milling in the manufacturing of solid dosage forms. The focus is on direct product impact with major criticality.
Responsibilities
It is the responsibility of the Validation Team to execute this OQ protocol, ensuring compliance with regulatory requirements and internal standards.
Prerequisites
All personnel involved in the execution of this protocol must be trained in Good Manufacturing Practices (GMP) and familiar with the operation of the Pin Mill.
Equipment Description
The Pin Mill is a high-speed milling device designed to produce fine particle sizes in solid dosage forms. Key features include adjustable disc speed, temperature control, and a robust design for continuous operation.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-PM-01 | Verify disc speed output | Disc speed within specified range | Calibration report |
| OQ-PM-02 | Measure particle size distribution (PSD) | PSD meets URS specifications | Test results |
| OQ-PM-03 | Monitor temperature during operation | Temperature remains within specified limits | Temperature log |
Detailed Test Cases
Test Case 1: Verify Disc Speed Output
Procedure: Set the Pin Mill to the desired operating speed and record the output speed using a calibrated tachometer. Compare against the specified range in the URS.
Acceptance Criteria: Disc speed must be within the specified range as per URS.
Evidence: Calibration report and recorded measurements.
Test Case 2: Measure Particle Size Distribution (PSD)
Procedure: Collect samples during milling and analyze using a laser diffraction particle size analyzer.
Acceptance Criteria: PSD must meet the specifications outlined in the URS.
Evidence: Test results report from the particle size analyzer.
Test Case 3: Monitor Temperature During Operation
Procedure: Continuously monitor the temperature of the milling chamber during operation and log data.
Acceptance Criteria: Temperature must remain within the specified limits as per URS.
Evidence: Temperature log and compliance report.
Deviations
Any deviations from the protocol must be documented and justified. A deviation report will be generated for review and approval.
Approvals
All test results and deviations must be reviewed and approved by the Validation Team Lead and Quality Assurance.