Standard Operating Procedure for Equipment Validation of RABS/Isolator in Ophthalmics
Purpose: To establish a standardized approach for the validation of RABS/Isolator equipment used in the production of sterile eye drops and ointments, ensuring compliance with regulatory requirements and product safety.
Scope: This SOP applies to the validation of RABS/Isolator equipment utilized in the aseptic filling process for ophthalmic products within the production area.
Definitions:
- RABS: Restricted Access Barrier System – a controlled environment designed to minimize contamination risks during aseptic processing.
- Isolator: A containment system that provides a sterile environment for the production of pharmaceutical products.
- CSV: Computerized System Validation – a process to ensure that computer systems are validated for their intended use.
Roles:
- Validation Team: Responsible for executing validation activities and documentation.
- Quality Assurance: Ensures compliance with regulatory standards and approves validation protocols.
- Production Personnel: Operate the RABS/Isolator and adhere to SOPs.
Lifecycle Procedure:
- Design Qualification (DQ): Assess the design of the RABS/Isolator against user requirements.
- Installation Qualification (IQ): Verify that the equipment is installed according to specifications.
- Operational Qualification (OQ): Confirm that the equipment operates within specified limits.
- Performance Qualification (PQ): Validate the equipment’s performance under actual production conditions.
GDP Controls: Good Documentation Practices must be followed throughout the validation process to ensure traceability and accountability.
Acceptance Criteria Governance: Acceptance criteria shall align with URS, Annex 1, and Annex 11 regulatory requirements to ensure product impact is directly addressed.
Calibration/PM Governance: Regular calibration and preventive maintenance must be performed as per the manufacturer’s recommendations and documented accordingly.
Change Control Triggers: Any modifications to the RABS/Isolator equipment or processes must initiate a change control process to assess impact on validation status.
Revalidation Triggers and Periodic Review: Revalidation is required annually (12M) or upon significant changes to equipment or processes. Periodic reviews will ensure ongoing compliance and performance.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Calibration Records
- Maintenance Logs
- Change Control Documentation