Checkweigher (Inline) – Equipment Validation SOP

Standard Operating Procedure for Equipment Validation of Inline Checkweigher in Ophthalmics

Purpose: This SOP outlines the validation process for the Inline Checkweigher used in the packaging of sterile eye drops and ointments to ensure compliance with regulatory requirements and product quality.

Scope: This procedure applies to the validation of the Inline Checkweigher within the Packaging/Primary area for ophthalmic products.

Definitions:

  • Equipment Validation: The process of ensuring that the equipment operates according to its intended use and meets specified requirements.
  • Criticality: The importance of the equipment in maintaining product quality; classified as Critical for the Inline Checkweigher.
  • DQ/IQ/OQ/PQ: Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification.

Roles:

  • Validation Team: Responsible for the execution of validation activities.
  • Quality Assurance: Ensures compliance with regulatory standards and reviews validation documentation.
  • Maintenance Team: Conducts calibration and preventive maintenance as per schedule.

Lifecycle Procedure:

  1. Design Qualification (DQ): Document user requirements and specifications.
  2. Installation Qualification (IQ): Verify installation and documentation compliance.
  3. Operational Qualification (OQ): Test operational parameters and functionality.
  4. Performance Qualification (PQ): Validate equipment performance under actual operating conditions.

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

Acceptance Criteria Governance: Acceptance criteria will be governed by the User Requirements Specification (URS) as per Annex 11 compliance.

Calibration/PM Governance: The Inline Checkweigher will undergo calibration and preventive maintenance every 12 months, with records maintained as per company policy.

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Change Control Triggers: Any changes in equipment, processes, or materials that may impact the validation status will trigger a change control process.

Revalidation Triggers and Periodic Review: Revalidation will occur every 12 months or upon significant changes to the equipment or process.

Records/Attachments List:

  • Validation Protocols
  • Calibration Certificates
  • Change Control Records
  • Periodic Review Reports
  • Training Records

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