Lyophilizer SCADA / Control System – Equipment Validation SOP


Standard Operating Procedure for Lyophilizer SCADA / Control System Validation

Purpose: This SOP outlines the validation process for the Lyophilizer SCADA / Control System to ensure it meets regulatory requirements and product quality standards.

Scope: This procedure applies to the validation of the Lyophilizer SCADA / Control System used in the production of sterile powders and lyophilized products.

Definitions:

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

Roles:

  • Validation Team: Responsible for executing the validation protocol and documentation.
  • Quality Assurance: Reviews and approves validation documentation.
  • IT Department: Supports the technical aspects of the SCADA system.

Lifecycle Procedure:

  1. Design Qualification (DQ): Assess the design specifications and requirements.
  2. Installation Qualification (IQ): Verify that the system is installed according to specifications.
  3. Operational Qualification (OQ): Test the system’s operational performance against defined criteria.
  4. Performance Qualification (PQ): Validate the system’s performance in a production environment.

GDP Controls: Ensure Good Documentation Practices are followed throughout the validation process, including proper record-keeping and document control.

Acceptance Criteria Governance: Access to audit trails will be controlled to ensure data integrity. All changes must be tracked and documented.

Calibration/PM Governance: Regular calibration and preventive maintenance must be performed on the SCADA system to ensure consistent performance.

Change Control Triggers: Any changes to the system, software, or process must initiate a change control process, including impact assessment and revalidation if necessary.

Revalidation Triggers and Periodic Review: Revalidation is required upon significant changes to the system or process. Periodic reviews will be conducted at defined intervals to ensure ongoing compliance.

See also  Bin Dumper / IBC Dumper – DQ Protocol

Records/Attachments List:

  • Validation Protocols
  • Validation Reports
  • Change Control Records
  • Calibration and Maintenance Logs
  • Audit Trail Access Logs

Also Check:

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