Document Control:
Document Number: PQ-GLR-001
Version: 1.0
Date: 2023-10-01
Prepared By: [Your Name]
Approved By: [Approver’s Name]
Performance Qualification Protocol for Glass Lined Reactor in API Manufacturing
Meta Description: This document outlines the Performance Qualification (PQ) protocol for the Glass Lined Reactor used in API manufacturing, covering critical parameters and acceptance criteria.
Tags: Equipment Validation, Performance Qualification, API Manufacturing, Glass Lined Reactor
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Glass Lined Reactor (GLR) operates consistently and reliably within specified limits to ensure product quality and compliance with regulatory standards.
Scope
This protocol applies to the Glass Lined Reactor utilized in the chemical synthesis and purification of Active Pharmaceutical Ingredients (APIs) within the production area.
Responsibilities
The Validation Team is responsible for executing the PQ protocol, documenting results, and ensuring compliance with all applicable regulations. The Production Team will assist in the execution of the tests and provide necessary data.
Prerequisites
All prior validation activities, including Installation Qualification (IQ) and Operational Qualification (OQ), must be completed and documented before commencing this PQ protocol.
Equipment Description
The Glass Lined Reactor is designed for chemical synthesis reactions, featuring a robust glass lining to prevent contamination and facilitate easy cleaning. Key features include:
- Temperature Control
- Pressure Regulation
- Agitation System
- PLC Control System with Audit Trail
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TP-001 | Verify temperature control functionality | Temperature within ±2°C of set point | Temperature logs |
| TP-002 | Verify pressure control functionality | Pressure within ±5 psi of set point | Pressure logs |
| TP-003 | Verify agitation system performance | Agitation speed within ±10% of set point | Agitation logs |
| TP-004 | Verify PLC control and audit trail | Audit trail records all operations without gaps | PLC audit trail report |
Detailed Test Cases
Test Case 1: Temperature Control
Procedure: Set the reactor to a designated temperature and monitor for stability over 30 minutes. Record values at 5-minute intervals.
Expected Result: Temperature remains within ±2°C of the set point throughout the duration.
Test Case 2: Pressure Control
Procedure: Set the reactor to a designated pressure and monitor for stability over 30 minutes. Record values at 5-minute intervals.
Expected Result: Pressure remains within ±5 psi of the set point throughout the duration.
Test Case 3: Agitation System
Procedure: Set the reactor to a designated agitation speed and monitor for consistency over 30 minutes. Record values at 5-minute intervals.
Expected Result: Agitation speed remains within ±10% of the set point throughout the duration.
Test Case 4: PLC Control and Audit Trail
Procedure: Review the PLC audit trail for all operations during the test period.
Expected Result: The audit trail shows continuous logging of all operations without gaps.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan must be implemented to address any identified issues.
Approvals
By signing below, the following individuals approve this Performance Qualification protocol:
Prepared By: ______________________ Date: ___________
Approved By: ______________________ Date: ___________
Data Integrity Checks
Ensure that all recorded data is backed up and stored securely. Conduct regular audits of data logs to confirm accuracy and completeness.