Operational Qualification Protocol for Glass Lined Reactor in API Manufacturing
Document Number: OQ-GLR-001
Version: 1.0
Date: 2023-10-01
Prepared by: [Your Name]
Approved by: [Approver’s Name]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Glass Lined Reactor (GLR) operates according to predefined specifications and meets the requirements set forth in the User Requirement Specification (URS) and regulatory guidelines including Annex 11 and Annex 15.
Scope
This protocol applies to the Glass Lined Reactor (GLR) used in the production area for chemical synthesis reactions impacting product quality directly. The OQ will cover all critical parameters associated with the operation of the GLR.
Responsibilities
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the OQ documentation.
- Production Personnel: Responsible for operating the GLR during the qualification process.
Prerequisites
- Installation Qualification (IQ) must be completed and approved.
- All necessary training for personnel operating the GLR must be completed.
- All required materials and tools must be available for testing.
Equipment Description
The Glass Lined Reactor (GLR) is designed for chemical synthesis and purification processes. It features a glass-lined interior that provides excellent resistance to corrosive chemicals and offers a controlled environment for reactions.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-GLR-001-T1 | Verify temperature control functionality | Temperature maintained within ±2°C of set point | Temperature log |
| OQ-GLR-001-T2 | Verify pressure control functionality | Pressure maintained within specified limits | Pressure log |
| OQ-GLR-001-T3 | Verify agitation performance | Agitation speed within ±10% of set point | Agitation log |
| OQ-GLR-001-T4 | Verify reaction control via PLC | PLC audit trail shows accurate recording of parameters | PLC audit report |
Detailed Test Cases
Test Case 1: Temperature Control
Procedure: Set the GLR to a specific temperature and monitor the actual temperature. Record the data over a specified period.
Acceptance Criteria: Temperature maintained within ±2°C of set point.
Evidence: Temperature log showing set point and actual readings.
Test Case 2: Pressure Control
Procedure: Set the GLR to a specific pressure and monitor the actual pressure. Record the data over a specified period.
Acceptance Criteria: Pressure maintained within specified limits.
Evidence: Pressure log showing set point and actual readings.
Test Case 3: Agitation Performance
Procedure: Set the agitation speed and monitor the actual speed. Record the data over a specified period.
Acceptance Criteria: Agitation speed within ±10% of set point.
Evidence: Agitation log showing set point and actual readings.
Test Case 4: PLC Reaction Control
Procedure: Initiate a reaction and monitor the PLC for proper recording of parameters.
Acceptance Criteria: PLC audit trail shows accurate recording of parameters.
Evidence: PLC audit report showing recorded parameters during the reaction.
Deviations
Any deviations from the acceptance criteria will be documented and assessed for impact on the qualification status. A root cause analysis will be performed, and corrective actions will be implemented as necessary.
Approvals
This protocol must be reviewed and approved by the Quality Assurance department prior to execution. All results must be documented and reviewed following the completion of the OQ testing.