Standard Operating Procedure for Equipment Validation of Glass Lined Reactor
Purpose: This SOP outlines the procedures for validating the Glass Lined Reactor (GLR) used in API manufacturing to ensure compliance with regulatory standards and product quality.
Scope: This SOP applies to the validation of the Glass Lined Reactor utilized in the chemical synthesis and purification processes within the production area.
Definitions:
- GLR: Glass Lined Reactor, an equipment used for chemical synthesis.
- Validation: The process of establishing documented evidence that a system or process meets its intended use.
- DQ: Design Qualification.
- IQ: Installation Qualification.
- OQ: Operational Qualification.
- PQ: Performance Qualification.
Roles:
- Validation Team: Responsible for executing the validation protocol.
- Quality Assurance: Ensures compliance with regulatory standards and reviews validation documentation.
- Production Personnel: Operate the GLR and provide input during the validation process.
Lifecycle Procedure:
- Conduct Design Qualification (DQ) to ensure the GLR meets user requirements.
- Perform Installation Qualification (IQ) to verify the equipment is installed correctly.
- Execute Operational Qualification (OQ) to confirm the GLR operates within specified parameters.
- Complete Performance Qualification (PQ) to validate the GLR’s performance during actual production conditions.
GDP Controls: Good Documentation Practices must be adhered to throughout the validation process, ensuring all records are clear, accurate, and complete.
Acceptance Criteria Governance: Acceptance criteria will be established based on User Requirements Specifications (URS) and in accordance with Annex 11 and Annex 15 of the applicable regulations.
Calibration/PM Governance: The GLR must undergo regular calibration and preventive maintenance as per the manufacturer’s recommendations and internal policies to ensure ongoing compliance and performance.
Change Control Triggers: Any modifications to the GLR or its operating procedures must initiate a change control process to assess the impact on validation status.
Revalidation Triggers and Periodic Review: Revalidation is required every 12 months or whenever significant changes occur that may affect the GLR’s performance or compliance.
Records/Attachments List:
- Validation Protocols (DQ/IQ/OQ/PQ)
- Calibration and Maintenance Records
- Change Control Documentation
- Periodic Review Reports