Standard Operating Procedure for Equipment Validation of Coding/Printing Machines

Purpose: The purpose of this SOP is to outline the validation process for Coding/Printing Machines (Inkjet/Laser) used in the packaging of IV Infusions, ensuring compliance with regulatory requirements and maintaining product quality.

Scope: This SOP applies to all personnel involved in the validation and operation of Coding/Printing Machines within the Packaging/Primary area for IV Infusions (LVP/SVP – Bags/Bottles).

Definitions:

• IV Infusions: Intravenous solutions administered to patients.
• Criticality: The importance of equipment in ensuring product quality.
• DQ/IQ/OQ/PQ: Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification.
• CSV: Computerized System Validation.

Roles:

• Validation Team: Responsible for conducting validation activities and documentation.
• Quality Assurance: Ensures compliance with regulatory standards.
• Operations Personnel: Operates and maintains the equipment.

Lifecycle Procedure:

1. Design Qualification (DQ): Verify that the design meets user requirements.
2. Installation Qualification (IQ): Confirm that the equipment is installed correctly.
3. Operational Qualification (OQ): Assess the operational performance of the equipment.
4. Performance Qualification (PQ): Validate the equipment under actual operating conditions.

Good Documentation Practices (GDP) Controls:

• All validation documents must be completed, reviewed, and approved.
• Records should be maintained in a secure manner to ensure integrity and traceability.

Acceptance Criteria Governance:

• Acceptance criteria shall be defined in the User Requirement Specification (URS) Annex 11.
• All criteria must be met for successful validation.

Calibration/PM Governance:

• Calibration and preventive maintenance must be performed as per the schedule.
• Records of calibration and maintenance must be maintained and reviewed regularly.

Change Control Triggers:

• Any changes to the equipment, process, or materials that may affect performance must initiate a change control process.

Revalidation Triggers and Periodic Review:

• Revalidation is required annually or whenever significant changes occur.
• Periodic reviews must be conducted to ensure ongoing compliance and performance.

Records/Attachments List:

• Validation Protocols
• Validation Reports
• Calibration Certificates
• Maintenance Logs
• Change Control Records