Document Control Number: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Performance Qualification Protocol for Dose Metering Test System
Meta Description: This document outlines the Performance Qualification Protocol for the Dose Metering Test System used in the validation of nasal and otic products, ensuring compliance with URS Annex11.
Tags: Equipment Validation, Performance Qualification, Nasal Products, Otic Products
Objective
The objective of this protocol is to verify the delivered dose and spray characteristics of the Dose Metering Test System, ensuring compliance with regulatory requirements and product specifications.
Scope
This protocol applies to the validation of the Dose Metering Test System used in the QC/Production area for both sterile and non-sterile nasal and otic products.
Responsibilities
The following personnel are responsible for the execution of this protocol:
- Validation Team: Overall execution and documentation.
- Quality Assurance: Review and approval of the protocol and results.
- Production Team: Provide necessary samples and support during testing.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of necessary equipment and materials for testing.
- Training of personnel on the operation of the Dose Metering Test System.
Equipment Description
The Dose Metering Test System is an instrument designed to measure the spray pattern and shot weight of nasal and otic products. It allows for precise evaluation of dose uniformity and spray geometry, ensuring product quality and compliance.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TP-001 | Measure dose uniformity across multiple samples. | Mean dose within ±10% of target. | Recorded measurements and statistical analysis. |
| TP-002 | Evaluate spray geometry using calibrated imaging. | Spray pattern meets defined specifications. | Imaging results and analysis report. |
Detailed Test Cases
Test Case 1: Dose Uniformity
- Collect 10 samples from the production batch.
- Measure the delivered dose using the Dose Metering Test System.
- Calculate the mean and standard deviation.
- Document results in the validation report.
Test Case 2: Spray Geometry
- Set up the imaging system to capture spray pattern.
- Activate the Dose Metering Test System to produce spray.
- Analyze the captured images for consistency with specifications.
- Document findings in the validation report.
Deviations
Any deviations from the protocol must be documented and justified. A deviation report should be submitted to the Quality Assurance team for review and approval.
Approvals
The following signatures are required to approve this Performance Qualification Protocol:
- _________________________ (Validation Team Lead)
- _________________________ (Quality Assurance)
- _________________________ (Production Manager)
Data Integrity Checks
As CSV is required, the following data integrity checks will be implemented:
- Automated data logging of measurements with timestamps.
- Access controls to ensure only authorized personnel can modify data.
- Periodic audits of the data logs to verify compliance with established protocols.