Standard Operating Procedure for the Validation of Ophthalmic Compounding Vessel
Purpose: This SOP outlines the validation process for the Ophthalmic Compounding Vessel, ensuring compliance with regulatory requirements and product quality standards.
Scope: This procedure applies to the validation of the Ophthalmic Compounding Vessel used in the production of sterile eye drops and eye ointments within the production area.
Definitions:
- DQ: Design Qualification
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
- CSV: Computerized System Validation
Roles:
- Validation Team: Responsible for executing and documenting validation activities.
- Quality Assurance: Ensures compliance with validation requirements and regulatory standards.
- Production Staff: Operates the equipment and follows validated procedures.
Lifecycle Procedure:
- Design Qualification (DQ): Confirm that the design meets user requirements.
- Installation Qualification (IQ): Verify that the equipment is installed correctly and according to specifications.
- Operational Qualification (OQ): Test the equipment’s functionality under normal operating conditions.
- Performance Qualification (PQ): Validate the equipment’s performance in producing the required product quality.
GDP Controls: Good Documentation Practices (GDP) must be adhered to throughout the validation process to ensure traceability and compliance.
Acceptance Criteria Governance: Validation must comply with URS, Annex 1, Annex 11, and Annex 15 regulatory standards. Acceptance criteria will be defined during the DQ phase.
Calibration/PM Governance: The Ophthalmic Compounding Vessel must undergo regular calibration and preventive maintenance as per the manufacturer’s specifications and internal SOPs.
Change Control Triggers: Any modifications to the equipment, process, or materials that may impact product quality must initiate a change control process.
Revalidation Triggers and Periodic Review: Revalidation is required every 12 months or when significant changes occur that may affect the equipment’s performance or product quality.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Calibration Records
- Change Control Documentation
- Revalidation Schedules