Water System (PW/WFI) – Point of Use for LVP – Equipment Validation SOP

Standard Operating Procedure for Water System Validation in IV Infusions

Purpose

The purpose of this SOP is to outline the validation process for the Water System (PW/WFI) used at the point of use for LVP/SVP compounding, ensuring compliance with regulatory requirements and maintaining product quality.

Scope

This SOP applies to the validation of the Water System (PW/WFI) utilized for compounding and cleaning in place (CIP) processes within the Utilities area, impacting the quality of IV infusions.

Definitions

  • PW: Purified Water
  • WFI: Water for Injection
  • IV: Intravenous
  • LVP: Large Volume Parenterals
  • SVP: Small Volume Parenterals
  • CSV: Computerized System Validation

Roles

  • Validation Team: Responsible for conducting validation activities and documenting results.
  • Quality Assurance: Ensures compliance with regulatory standards and reviews validation documentation.
  • Maintenance Personnel: Conducts routine maintenance and calibration of the Water System.

Lifecycle Procedure

  1. Design Qualification (DQ): Ensure design meets user requirements.
  2. Installation Qualification (IQ): Verify installation meets specifications.
  3. Operational Qualification (OQ): Confirm system operates within defined parameters.
  4. Performance Qualification (PQ): Validate system performance under actual operating conditions.

GDP Controls

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

Acceptance Criteria Governance

Acceptance criteria shall be established based on User Requirements Specification (URS) and in accordance with Annex 11 and Annex 15 of the applicable regulatory guidelines.

Calibration/PM Governance

Calibration and preventive maintenance (PM) shall be performed in accordance with established schedules and documented in the maintenance log to ensure ongoing compliance and functionality of the Water System.

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Change Control Triggers

Any changes to the Water System or its operating procedures that may impact product quality or system performance must be evaluated through the change control process.

Revalidation Triggers and Periodic Review

Revalidation is required annually or upon significant changes to the system, processes, or product formulations. A periodic review of the validation status shall be conducted to ensure continued compliance.

Records/Attachments List

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

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