Standard Operating Procedure for the Validation of Nitrogen Purging System in Ophthalmics Production
Purpose: To outline the validation process for the Nitrogen Purging System used in the production of sterile eye drops and eye ointments, ensuring compliance with regulatory requirements and product quality standards.
Scope: This SOP applies to the Nitrogen Purging System utilized in the production area for headspace purging in the manufacturing of ophthalmic products.
Definitions:
- DQ: Design Qualification
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
- CSV: Computer System Validation
Roles:
- Quality Assurance: Responsible for approving validation protocols and reports.
- Validation Team: Executes validation activities and documentation.
- Production Personnel: Operate the Nitrogen Purging System and adhere to SOPs.
Lifecycle Procedure:
- Conduct Design Qualification (DQ) to establish requirements.
- Perform Installation Qualification (IQ) to verify installation against specifications.
- Execute Operational Qualification (OQ) to ensure the system operates within defined limits.
- Complete Performance Qualification (PQ) to confirm the system produces the desired outcomes.
GDP Controls: Ensure Good Documentation Practices are followed throughout the validation process, maintaining traceability and integrity of records.
Acceptance Criteria Governance: Acceptance criteria will be governed by User Requirement Specifications (URS) in accordance with Annex 11 of the applicable regulations.
Calibration/PM Governance: The Nitrogen Purging System must undergo regular calibration and preventive maintenance as per the manufacturer’s recommendations and internal SOPs.
Change Control Triggers: Any changes to the Nitrogen Purging System, including software updates, hardware modifications, or process changes, will initiate a change control process.
Revalidation Triggers and Periodic Review: Revalidation of the Nitrogen Purging System will occur annually or upon significant changes to the system or production process.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Change Control Documents
- Calibration Certificates
- Maintenance Logs