Document Control
Document Number: DQ-OSD-TCCF-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Design Qualification Protocol for Tablet/Capsule Counter Filler
Meta Description: This document outlines the Design Qualification Protocol for the Tablet/Capsule Counter Filler, focusing on equipment validation in the solid dosage form category.
Tags: Equipment Validation, DQ Protocol, Solid Dosage Form, Tablet Counter, Capsule Filler
Objective
The objective of this Design Qualification (DQ) Protocol is to ensure that the Tablet/Capsule Counter Filler is designed and operates in accordance with the specified requirements outlined in the User Requirement Specification (URS) Annex 11.
Scope
This protocol applies to the validation of the Tablet/Capsule Counter Filler used in the packaging area for counting and filling tablets and capsules into bottles.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Engineering: Responsible for providing technical support and equipment specifications.
Prerequisites
- Completion of the User Requirement Specification (URS).
- Installation and operational qualification of the Tablet/Capsule Counter Filler.
- Training of personnel on the operation of the equipment.
Equipment Description
The Tablet/Capsule Counter Filler is designed for counting and filling tablets and capsules into bottles. It operates with the following key critical parameters:
- Counting accuracy
- Speed
- Rejects
- Audit trail
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify counting accuracy | Count within ± 2% of actual | Test report |
| T2 | Measure speed of operation | Speed within specified limits | Performance log |
| T3 | Check reject functionality | No false rejects | Test report |
| T4 | Verify audit trail | Complete and accurate audit log | Audit log review |
Detailed Test Cases
Test Case T1: Verify Counting Accuracy
Procedure: Conduct a test with a known quantity of tablets/capsules and compare the count recorded by the equipment.
Acceptance Criteria: Count must be within ± 2% of the actual quantity.
Evidence: Documented test results and verification report.
Test Case T2: Measure Speed of Operation
Procedure: Measure the time taken to fill a specified number of bottles.
Acceptance Criteria: Speed must be within the specified operational limits.
Evidence: Performance log and time measurement report.
Test Case T3: Check Reject Functionality
Procedure: Introduce a known faulty item and verify that it is rejected by the system.
Acceptance Criteria: No false rejects should occur during the test.
Evidence: Documented test results.
Test Case T4: Verify Audit Trail
Procedure: Review the audit trail generated during operation.
Acceptance Criteria: The audit log should be complete and accurate.
Evidence: Audit log review report.
Deviations
Any deviations from the acceptance criteria must be documented and justified. A corrective action plan must be implemented for any critical deviations.
Approvals
Prepared by: [Name], [Title], [Date]
Reviewed by: [Name], [Title], [Date]
Approved by: [Name], [Title], [Date]