Equipment Validation SOP for Case Packer in IV Infusions
Purpose: To ensure the Case Packer used for packaging IV Infusions (LVP/SVP – Bags/Bottles) is validated in accordance with regulatory requirements and internal quality standards.
Scope: This SOP applies to the validation of the Case Packer located in the Packaging/Secondary area, focusing on its use for packing cartons into shippers.
Definitions:
- Equipment Validation: A documented process to ensure that equipment operates as intended and produces consistent results.
- IV Infusions: Intravenous solutions provided in large volume parenterals (LVP) or small volume parenterals (SVP).
- CSV: Computerized System Validation.
Roles:
- Validation Team: Responsible for the execution and documentation of validation activities.
- Quality Assurance: Ensures compliance with regulatory requirements and internal policies.
- Operations: Provides operational support and input during validation activities.
Lifecycle Procedure:
- Design Qualification (DQ): Assess the design specifications of the Case Packer.
- Installation Qualification (IQ): Verify that the Case Packer is installed correctly and according to manufacturer specifications.
- Operational Qualification (OQ): Confirm that the Case Packer operates within predetermined limits.
- Performance Qualification (PQ): Validate the Case Packer’s performance in actual operational conditions.
GDP Controls: Good Documentation Practices must be followed at all stages of the validation process to ensure traceability and accountability.
Acceptance Criteria Governance: Acceptance criteria for validation will be governed by the User Requirement Specification (URS) as per Annex 11 guidelines.
Calibration/PM Governance: The Case Packer must undergo regular calibration and preventive maintenance as per the manufacturer’s recommendations and internal procedures.
Change Control Triggers: Any changes to the Case Packer, including software updates or modifications, must initiate a change control process to assess potential impacts on validation status.
Revalidation Triggers and Periodic Review: Revalidation is required every 12 months, or when significant changes occur that may impact the equipment’s validated state.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Change Control Documentation
- Calibration and PM Records
- Training Records