Vision System (Code/Label Verification) – Equipment Validation SOP

Standard Operating Procedure for the Validation of Vision System in IV Infusions

Equipment Validation,
IV Infusions,
Vision System,
Packaging,
Inspection

Purpose

This SOP provides guidelines for the validation of the Vision System used for code and label verification in IV Infusions, ensuring compliance and product integrity.

Scope

This procedure applies to the validation of the Vision System utilized in the Packaging and Inspection areas for both Large Volume Parenterals (LVP) and Small Volume Parenterals (SVP) in bags and bottles.

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 process.
  • Quality Assurance: Ensures compliance with regulatory requirements.
  • Operations: Provides input on operational requirements and system use.

Lifecycle Procedure

  1. Design Qualification (DQ): Document user requirements and specifications.
  2. Installation Qualification (IQ): Verify installation meets specifications.
  3. Operational Qualification (OQ): Test system operation under simulated conditions.
  4. Performance Qualification (PQ): Validate system performance with actual product.

GDP Controls

Good Documentation Practices (GDP) must be followed throughout the validation process to ensure traceability and compliance.

Acceptance Criteria Governance

Acceptance criteria must align with User Requirements Specification (URS) Annex 11 to ensure compliance and product safety.

Calibration/PM Governance

Regular calibration and preventive maintenance (PM) must be conducted as per the manufacturer’s guidelines and documented accordingly.

Change Control Triggers

Any changes to the Vision System or its operating procedures must trigger a change control process, including re-evaluation of validation status.

See also  Vision System – Qualification Execution Checklist

Revalidation Triggers and Periodic Review

Revalidation is required every 12 months or when significant changes occur. Periodic reviews should assess system performance and compliance.

Records/Attachments List

  • Validation Protocols
  • Validation Reports
  • Calibration Certificates
  • Change Control Documentation
  • Periodic Review Reports

Also Check:

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