Performance Qualification Protocol for Capsule/Blister Filler Used in Inhaled NDDS Powders
Document Control:
Document Number: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Objective
The objective of this Performance Qualification (PQ) protocol is to demonstrate that the Capsule/Blister Filler for inhalation powder dose units operates consistently within established parameters to ensure product quality and compliance with regulatory requirements.
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 critical parameters that impact product quality.
Responsibilities
The Validation Team is responsible for executing this protocol, documenting results, and reporting any deviations. The Quality Assurance team will review and approve the final report.
Prerequisites
All personnel involved must be trained on the operation of the Capsule/Blister Filler and have a clear understanding of the validation process. Equipment must be calibrated and maintained per the manufacturer’s specifications.
Equipment Description
The Capsule/Blister Filler is designed for filling inhalation powder dose units with engineered particles. It operates under controlled conditions to ensure fill weight uniformity.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Fill Weight Uniformity Test | All filled units must be within ±5% of target weight | Weight records, calibration certificates |
| PQ-02 | Reject Logic Audit Trail Verification | Audit trail must show all rejects and corrective actions | System logs, audit trail reports |
Detailed Test Cases
Test Case: Fill Weight Uniformity
1. Set the target weight for the inhalation powder dose unit.
2. Fill a batch of units and record the weight of each unit.
3. Calculate the average weight and standard deviation.
4. Compare results against acceptance criteria.
Test Case: Reject Logic Audit Trail
1. Trigger reject logic by simulating a weight deviation.
2. Review the audit trail for accurate recording of the reject.
3. Ensure corrective actions are documented.
Deviations
Any deviations from the protocol must be documented, investigated, and resolved. A deviation report must be generated for review.
Approvals
This protocol must be approved by the Quality Assurance Manager and the Validation Lead before execution.
Data Integrity Checks
1. Ensure that all data entries are timestamped and attributed to the user.
2. Regularly back up system data to prevent loss.
3. Conduct periodic reviews of data logs to ensure compliance with regulatory standards.