Standard Operating Procedure for the Validation of VHP Decontamination Unit in Ophthalmics Production
Purpose: This SOP outlines the validation process for the VHP Decontamination Unit utilized in the production of sterile eye drops and eye ointments to ensure compliance with regulatory standards and product integrity.
Scope: This procedure applies to the VHP Decontamination Unit used in the production area for decontaminating barriers and rooms within the ophthalmics manufacturing environment.
Definitions:
- VHP: Vaporized Hydrogen Peroxide
- DQ: Design Qualification
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
Roles:
- Validation Team: Responsible for executing validation protocols.
- Quality Assurance: Ensures compliance with regulatory requirements.
- Production Personnel: Operate and maintain the equipment.
Lifecycle Procedure:
- Design Qualification (DQ): Assess requirements and specifications.
- Installation Qualification (IQ): Verify equipment installation meets specifications.
- Operational Qualification (OQ): Validate the operational parameters.
- Performance Qualification (PQ): Confirm the equipment performs as intended in a production environment.
GDP Controls: Good Documentation Practices must be followed throughout all validation phases, ensuring all records are complete and accurate.
Acceptance Criteria Governance: Acceptance criteria will be established based on User Requirements Specification (URS) and relevant guidelines from Annex 1 and Annex 11.
Calibration/PM Governance: The VHP Decontamination Unit must undergo regular calibration and preventive maintenance per the manufacturer’s recommendations and internal protocols to ensure continued compliance.
Change Control Triggers: Any modification to the equipment, process, or environment that may impact the validation status must initiate a change control process.
Revalidation Triggers and Periodic Review: Revalidation is required annually, or sooner if changes occur that may affect the equipment’s performance or compliance.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Calibration Records
- Maintenance Logs
- Change Control Documentation