Performance Qualification Protocol for Induction Sealing Machine in Solid Dosage Form
Document Control:
Document Number: PQ-IS-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Approved By: [Insert Name]
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Induction Sealing Machine operates consistently and reliably within specified limits to ensure the integrity of seals on solid dosage form products.
Scope
This protocol applies to the Induction Sealing Machine utilized in the packaging area for sealing liners of solid dosage forms. The validation will cover the critical parameters that impact product quality.
Responsibilities
The Validation Team is responsible for the execution of this protocol. The Quality Assurance (QA) department will review and approve the final report.
Prerequisites
All necessary equipment and materials must be available and calibrated. Personnel must be trained on the operation of the Induction Sealing Machine and the validation process.
Equipment Description
The Induction Sealing Machine is designed to seal liners on containers using induction heating technology. It operates within specified parameters to ensure seal integrity for solid dosage forms.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| TP-01 | Measure power conveyor speed | Within specified limits | Calibration report |
| TP-02 | Perform seal integrity tests | 100% seal integrity | Seal integrity test results |
Detailed Test Cases
Test Case 1: Power Conveyor Speed
Procedure: Measure the speed of the conveyor during operation. Ensure it is within the specified limits.
Acceptance Criteria: Speed must be within the range established in the URS Annex11.
Evidence: Record of speed measurements and calibration certificates.
Test Case 2: Seal Integrity
Procedure: Conduct seal integrity tests using a standardized method. Document all results.
Acceptance Criteria: All seals must pass integrity tests with no leaks.
Evidence: Test results and any photographs of the seals.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis will be performed, and corrective actions will be implemented as necessary.
Approvals
This protocol must be reviewed and approved by the QA department before execution.