Performance Qualification Protocol for the Suppository Stripping Machine
Document Control:
Document Number: PQ-SS-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Suppository Stripping Machine operates in accordance with predefined specifications and meets the acceptance criteria outlined in the User Requirement Specification (URS) Annex 11.
Scope
This protocol applies to the Performance Qualification of the Suppository Stripping Machine used in the production area for the removal of suppositories from molds. This validation is critical as it directly impacts product quality.
Responsibilities
The Validation Team is responsible for executing the PQ protocol, documenting results, and ensuring compliance with applicable regulations. The Production Team will assist in the operation of the equipment during the qualification process.
Prerequisites
1. Completion of Installation Qualification (IQ) and Operational Qualification (OQ) protocols.
2. Availability of necessary materials and resources for testing.
3. Training of personnel on equipment operation and data recording.
Equipment Description
The Suppository Stripping Machine is designed to efficiently remove suppositories from molds while ensuring minimal risk of damage. Key features include:
- Automated stripping mechanism
- Adjustable stripping alignment
- Reject logic for non-conforming products
- Audit trail functionality for compliance tracking
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001 | Verify stripping alignment | Alignment within specified tolerance | Calibration report |
| PQ-002 | Audit trail validation | All actions logged accurately | Audit trail report |
Detailed Test Cases
Test Case ID: PQ-001
Objective: To ensure proper alignment of the stripping mechanism.
Procedure: Run the machine with test suppositories and measure the alignment.
Acceptance Criteria: Stripping alignment must be within +/- 0.5 mm.
Expected Outcome: All suppositories stripped without damage.
Test Case ID: PQ-002
Objective: To verify that the audit trail captures all relevant actions.
Procedure: Perform a series of operations and review the audit trail.
Acceptance Criteria: All actions must be logged with timestamps and user IDs.
Expected Outcome: Complete and accurate audit trail is generated.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed to determine corrective actions.
Approvals
Prepared By: [Name] – Validation Specialist
Reviewed By: [Name] – Quality Assurance
Approved By: [Name] – Operations Manager
Data Integrity Checks
1. Ensure all data entries are time-stamped and user-identified.
2. Regularly back up audit trail data to prevent loss.
3. Conduct periodic reviews of data for accuracy and completeness.