Inline Sterile Filtration Skid – Equipment Validation SOP

Standard Operating Procedure for the Validation of Inline Sterile Filtration Skid

Equipment Validation,
Sterile Filtration,
Pharmaceutical Validation,
Production

Purpose

This SOP aims to establish a standardized approach for the validation of the Inline Sterile Filtration Skid, ensuring compliance with regulatory requirements and maintaining product quality.

Scope

This procedure applies to the validation of the Inline Sterile Filtration Skid used for sterilizing filtration prior to filling sterile powders and lyophilized products in the production area.

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.
  • Quality Assurance: Ensures compliance with SOPs and regulatory standards.
  • Production Personnel: Operates the Inline Sterile Filtration Skid and provides operational insights.

Lifecycle Procedure

  1. Conduct Design Qualification (DQ) to ensure system design meets user requirements.
  2. Perform Installation Qualification (IQ) to verify that the system is installed according to specifications.
  3. Execute Operational Qualification (OQ) to confirm that the system operates within defined parameters.
  4. Carry out Performance Qualification (PQ) to demonstrate that the system consistently produces the desired output.

Good Documentation Practices (GDP) Controls

All validation activities must be documented in accordance with Good Documentation Practices. Records should be clear, concise, and traceable to the specific validation activity.

Acceptance Criteria Governance

Acceptance criteria for validation shall be established based on the User Requirement Specification (URS) and must comply with Annex 1 and Annex 11 of the relevant regulatory guidelines.

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Calibration and Preventive Maintenance Governance

The Inline Sterile Filtration Skid must be calibrated and maintained according to the manufacturer’s specifications and internal SOPs. Calibration records must be retained for audit purposes.

Change Control Triggers

Any changes to the Inline Sterile Filtration Skid, including modifications to hardware or software, shall trigger a change control process to assess the impact on validation status.

Revalidation Triggers and Periodic Review

Revalidation shall occur every 12 months or when significant changes are made to the system, processes, or product to ensure ongoing compliance and effectiveness.

Records and Attachments List

  • Validation Protocols (DQ, IQ, OQ, PQ)
  • Calibration Records
  • Change Control Documentation
  • Periodic Review Records
  • Training Records for Personnel

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