Standard Operating Procedure for Validation of Prefilled Syringe Filling Machine
Purpose: This SOP outlines the validation process for the Prefilled Syringe Filling Machine used in the production of sterile drugs to ensure compliance with regulatory standards and maintain product integrity.
Scope: This procedure applies to the validation of the Prefilled Syringe Filling Machine in the production area, covering all phases of the validation lifecycle including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Definitions:
- Equipment Validation: A documented process that demonstrates that a piece of equipment consistently produces results meeting predetermined specifications.
- Criticality: The significance of the equipment in impacting product quality, categorized as Critical for this machine.
- CSV: Computer System Validation, required for systems associated with the equipment.
Roles:
- Validation Team: Responsible for planning and executing the validation process.
- Quality Assurance: Oversees compliance and ensures validation documentation is maintained.
- Production Personnel: Operate the equipment and provide feedback during the validation process.
Lifecycle Procedure:
- Design Qualification (DQ): Evaluate the design specifications against user requirements.
- Installation Qualification (IQ): Confirm that the equipment is installed correctly and according to specifications.
- Operational Qualification (OQ): Test the equipment under operational conditions to ensure it functions as intended.
- Performance Qualification (PQ): Validate the equipment’s performance with actual product to ensure it meets quality standards.
GDP Controls: Good Documentation Practices (GDP) must be adhered to throughout all stages of validation to ensure traceability and compliance.
Acceptance Criteria Governance: Acceptance criteria will follow the guidelines set forth in URS, Annex 1, and Annex 11, ensuring all validation activities meet regulatory requirements.
Calibration/PM Governance: The equipment must undergo regular calibration and preventive maintenance according to the manufacturer’s specifications and internal quality standards.
Change Control Triggers: Any changes to the equipment, software, or processes must initiate a change control process, including revalidation as necessary.
Revalidation Triggers and Periodic Review: Revalidation is required every 12 months or whenever significant changes occur that may impact the equipment’s performance or product quality.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Calibration Records
- Change Control Documentation
- Periodic Review Records