Ophthalmic Bottle Washing Machine – Equipment Validation SOP

Standard Operating Procedure for the Validation of Ophthalmic Bottle Washing Machines

Purpose

The purpose of this SOP is to outline the validation process for the Ophthalmic Bottle Washing Machine, ensuring compliance with regulatory requirements and quality standards.

Scope

This SOP applies to the validation of the Ophthalmic Bottle Washing Machine used in the production area for sterile eye drops and eye ointments.

Definitions

  • DQ: Design Qualification
  • IQ: Installation Qualification
  • OQ: Operational Qualification
  • PQ: Performance Qualification
  • CSV: Computerized System Validation
  • URS: User Requirements Specification

Roles

Key roles involved in the validation process include:

  • Validation Manager
  • Quality Assurance Personnel
  • Production Personnel
  • Maintenance Personnel

Lifecycle Procedure

  1. Conduct Design Qualification (DQ) to ensure the design meets user requirements.
  2. Perform Installation Qualification (IQ) to verify that the equipment is installed correctly.
  3. Execute Operational Qualification (OQ) to confirm that the equipment operates according to specifications.
  4. Carry out Performance Qualification (PQ) to validate the equipment’s performance under actual production conditions.

GDP Controls

Good Documentation Practices (GDP) must be followed throughout the validation process, ensuring all records are accurate, complete, and legible.

Acceptance Criteria Governance

Acceptance criteria will be based on User Requirements Specification (URS) Annex 11, ensuring that all requirements are met prior to equipment release.

Calibration/PM Governance

Calibration and preventive maintenance (PM) schedules must be established and adhered to, ensuring the equipment remains in a validated state.

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Change Control Triggers

Any changes to the equipment, processes, or materials that may impact the validation status must trigger a change control process.

Revalidation Triggers and Periodic Review

Revalidation is required every 12 months or whenever significant changes occur that may affect the validated state of the equipment.

Records/Attachments List

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

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