Nasal/Otic Compounding Vessel (Jacketed SS) – Equipment Validation SOP

Standard Operating Procedure for Validation of Nasal/Otic Compounding Vessel

Purpose

This SOP outlines the validation process for the Nasal/Otic Compounding Vessel to ensure compliance with regulatory requirements and to guarantee product quality and safety.

Scope

This procedure applies to the validation of the Nasal/Otic Compounding Vessel used in the production area for preparing nasal and otic bulk solutions or suspensions.

Definitions

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

Roles

The following roles are involved in the validation process:

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

Lifecycle Procedure

  1. Conduct Design Qualification (DQ) to ensure the equipment meets user requirements.
  2. Perform Installation Qualification (IQ) to verify the equipment is installed correctly.
  3. Execute Operational Qualification (OQ) to confirm the equipment operates as intended.
  4. Carry out Performance Qualification (PQ) to demonstrate the equipment produces the desired results.

Good Documentation Practices (GDP) Controls

All validation documents must be completed accurately, signed, and dated, following Good Documentation Practices (GDP).

Acceptance Criteria Governance

Acceptance criteria must align with URS requirements and comply with Annex 1, Annex 11, and Annex 15 of the relevant regulations.

Calibration and Preventive Maintenance Governance

Calibration and preventive maintenance must be conducted according to the defined schedule and documented appropriately.

Change Control Triggers

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

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Revalidation Triggers and Periodic Review

Revalidation is required annually or upon significant changes to the equipment or processes. Periodic reviews should be conducted to ensure ongoing compliance.

Records and Attachments List

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

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