Standard Operating Procedure for Equipment Validation of Coding/Printing Machine
Purpose: This SOP outlines the validation process for the Coding/Printing Machine used in the packaging of Sterile Eye Drops and Eye Ointments, ensuring compliance with regulatory requirements and product quality standards.
Scope: This SOP applies to the validation of the Coding/Printing Machine in the Packaging/Primary area for the production of ophthalmic products.
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 the validation activities.
- Quality Assurance: Ensures compliance with regulatory requirements and reviews validation documentation.
- Operations: Provides operational insights and assists in the validation process.
Lifecycle Procedure:
- Design Qualification (DQ): Assess user requirements and ensure the design meets specifications.
- Installation Qualification (IQ): Verify that the equipment is installed correctly and according to manufacturer specifications.
- Operational Qualification (OQ): Validate that the equipment operates within specified limits.
- Performance Qualification (PQ): Confirm that the equipment performs effectively under normal operating conditions.
GDP Controls: Ensure Good Documentation Practices are followed throughout the validation process, including proper record-keeping and version control.
Acceptance Criteria Governance: Acceptance criteria will be established based on User Requirements Specification (URS) Annex 11, ensuring all critical parameters are met.
Calibration/PM Governance: The Coding/Printing Machine will undergo regular calibration and preventive maintenance as per the manufacturer’s recommendations and internal policies.
Change Control Triggers: Any changes to the equipment, processes, or materials that may affect product quality will initiate a change control process.
Revalidation Triggers and Periodic Review: Revalidation will occur every 12 months or in response to significant changes in processes or equipment.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Calibration Records
- Change Control Records
- Periodic Review Documentation