Standard Operating Procedure for Equipment Validation of Liquid Manufacturing Vessel
Purpose: This SOP outlines the validation process for the Liquid Manufacturing Vessel used in the production of non-sterile liquids, ensuring compliance with regulatory standards and product quality.
Scope: This procedure applies to the validation of the Liquid Manufacturing Vessel (SS Jacketed Tank) utilized in the compounding of oral liquids, syrups, and suspensions in the Production/Manufacturing area.
Definitions:
- DQ: Design Qualification
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
- CSV: Computerized System Validation
Roles:
- Validation Team: Responsible for executing the validation process.
- Quality Assurance: Ensures compliance with regulatory requirements.
- Production Personnel: Operate the equipment and provide input during validation.
Lifecycle Procedure:
- Conduct Design Qualification (DQ) to ensure the equipment meets user requirements.
- Perform Installation Qualification (IQ) to verify that the equipment is installed correctly.
- Execute Operational Qualification (OQ) to confirm the equipment operates within specified limits.
- Carry out Performance Qualification (PQ) to demonstrate the equipment consistently produces quality product.
GDP Controls: Good Documentation Practices must be followed throughout the validation process, ensuring all records are complete, accurate, and traceable.
Acceptance Criteria Governance: Acceptance criteria will be established based on User Requirement Specifications (URS) and Annex 11 compliance to ensure product impact is direct and critical.
Calibration/PM Governance: The Liquid Manufacturing Vessel must undergo regular calibration and preventive maintenance as per the manufacturer’s recommendations and internal SOPs.
Change Control Triggers: Any changes to the equipment, process, or product must initiate a change control process to assess potential impacts on validation status.
Revalidation Triggers and Periodic Review: Revalidation is required every 24 months or when significant changes occur, including equipment modifications or changes in manufacturing processes.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Calibration Certificates
- Change Control Records
- Periodic Review Records