Document Number: DQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Design Qualification Protocol for Capsule/Blister Filler for Inhaled NDDS Powders
Meta Description: This document outlines the Design Qualification Protocol for the Capsule/Blister Filler used in the production of inhalation powder dose units, focusing on critical parameters and compliance.
Tags: Equipment Validation, Design Qualification, NDDS, DPI
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Capsule/Blister Filler for inhaled NDDS powders meets the specified requirements and functions as intended in the production environment.
Scope
This protocol applies to the Capsule/Blister Filler used in the production area for filling inhalation powder dose units. It covers the validation of equipment critical to product quality and compliance with regulatory expectations.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Production Team: Responsible for providing operational input and support during the qualification process.
Prerequisites
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) must be completed prior to DQ execution.
- Staff training on equipment operation and safety protocols.
Equipment Description
The Capsule/Blister Filler is designed to fill inhalation powder dose units with engineered particles. It is critical for ensuring fill weight uniformity and maintaining product integrity.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T01 | Verify fill weight uniformity | Fill weight must meet specifications within ±5% of target | Weight logs, calibration certificates |
| T02 | Audit reject logic | Reject logic must function correctly with documented audit trail | Audit trail logs, system screenshots |
Detailed Test Cases
Test Case T01: Verify Fill Weight Uniformity
Procedure: Conduct fill weight measurements on a sample of filled capsules. Compare results against specified target weights.
Acceptance Criteria: All samples must fall within ±5% of the target fill weight.
Evidence: Documented weight measurements and compliance report.
Test Case T02: Audit Reject Logic
Procedure: Execute a series of fill operations and intentionally trigger reject logic. Verify that the system logs the rejection correctly.
Acceptance Criteria: The system must record an accurate audit trail of all rejected operations.
Evidence: Audit trail logs and system verification report.
Deviations
Any deviations from the protocol must be documented and justified. A corrective action plan should be developed and executed to address any issues identified during testing.
Approvals
Approved By: [Name]
Date of Approval: [Date]