Purified Water Generation System (PW System) – Equipment Validation SOP

Standard Operating Procedure for Validation of Purified Water Generation Systems

Purpose

This Standard Operating Procedure (SOP) defines the validation process for the Purified Water Generation System (PW System) to ensure it meets regulatory requirements and functions effectively in producing purified water for pharmaceutical use.

Scope

This SOP applies to the validation of the Purified Water Generation System used in the Utilities area for generating purified water, impacting product quality directly.

Definitions

  • DQ: Design Qualification
  • IQ: Installation Qualification
  • OQ: Operational Qualification
  • PQ: Performance Qualification
  • CSV: Computerized System Validation

Roles

The following roles are involved in the validation process:

  • Validation Team: Responsible for executing validation activities.
  • Quality Assurance: Ensures compliance with regulatory requirements.
  • Engineering: Provides technical support for equipment and systems.

Lifecycle Procedure

  1. Design Qualification (DQ): Document requirements and specifications.
  2. Installation Qualification (IQ): Verify that the system is installed correctly.
  3. Operational Qualification (OQ): Test the system’s operational capabilities.
  4. Performance Qualification (PQ): Confirm the system performs as intended under actual conditions.

Good Documentation Practices (GDP) Controls

All documentation related to the validation process must adhere to Good Documentation Practices to ensure accuracy and traceability.

Acceptance Criteria Governance

Acceptance criteria must align with User Requirement Specifications (URS), and comply with regulatory guidelines outlined in Annex 11 and Annex 15.

Calibration and Preventative Maintenance Governance

Calibration and maintenance schedules must be established and documented to ensure the system remains in a validated state.

Change Control Triggers

Any changes to the system, processes, or equipment that may impact the validated state must initiate a change control process.

See also  Ophthalmic Sterile Filtration Skid (0.22 µm) – IQ Protocol

Revalidation Triggers and Periodic Review

Revalidation is required every 12 months or upon significant changes to the system or process.

Records and Attachments List

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

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