Standard Operating Procedure for Validating Coding Machines in Packaging
Purpose: This SOP outlines the validation process for coding machines (laser/inkjet) used in the packaging of prefilled syringes and cartridges, ensuring compliance with regulatory requirements and product quality standards.
Scope: This procedure applies to all coding machines utilized in the packaging area for printing batch and expiry information on prefilled syringes and cartridges.
Definitions:
- Equipment Validation: A documented process that ensures equipment operates as intended and produces consistent results.
- Criticality: The importance of equipment to product quality; in this case, critical due to direct product impact.
- DQ/IQ/OQ/PQ: Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification.
Roles:
- Validation Team: Responsible for executing and documenting validation activities.
- Quality Assurance: Ensures compliance with regulatory standards and internal policies.
- Maintenance Personnel: Conducts regular maintenance and calibration of equipment.
Lifecycle Procedure:
- Design Qualification (DQ): Document requirements and specifications for the coding machine.
- Installation Qualification (IQ): Verify installation against specifications and requirements.
- Operational Qualification (OQ): Test the machine under normal operating conditions to ensure it meets performance criteria.
- Performance Qualification (PQ): Validate the machine’s performance with actual product under real-world conditions.
GDP Controls: Ensure Good Documentation Practices are followed during all validation activities, including proper record-keeping and documentation of results.
Acceptance Criteria Governance: Acceptance criteria must adhere to User Requirement Specifications (URS) Annex 11, ensuring that all printed information meets regulatory and customer requirements.
Calibration/PM Governance: The coding machine must undergo calibration and preventive maintenance (PM) every 12 months, with records maintained in accordance with internal procedures.
Change Control Triggers: Any changes to the coding machine, including software updates or hardware modifications, must initiate a change control process, requiring revalidation as necessary.
Revalidation Triggers and Periodic Review: Revalidation is required every 12 months or when significant changes occur. A periodic review of the validation status and performance should be conducted annually.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Calibration Certificates
- Change Control Records
- Maintenance Logs