Parts Washer (GMP) – Equipment Validation SOP

Equipment Validation Procedure for Parts Washer in Solid Dosage Form

Purpose: To establish a standardized approach for the validation of the Parts Washer used in the production of solid dosage forms, ensuring compliance with GMP standards and product quality.

Scope: This SOP applies to the validation lifecycle of the Parts Washer utilized in the cleaning of equipment parts within the production area of solid dosage forms.

Definitions:

  • GMP: Good Manufacturing Practices
  • DQ: Design Qualification
  • IQ: Installation Qualification
  • OQ: Operational Qualification
  • PQ: Performance Qualification
  • CSV: Computerized System Validation

Roles:

  • Validation Team: Responsible for the execution of the validation activities.
  • Quality Assurance: Ensures compliance with regulatory standards and reviews validation documentation.
  • Production Personnel: Operate the equipment and provide feedback during validation.

Lifecycle Procedure:

  1. Design Qualification (DQ): Evaluate the design specifications against user requirements.
  2. Installation Qualification (IQ): Verify that the Parts Washer is installed according to specifications.
  3. Operational Qualification (OQ): Confirm that the Parts Washer operates within defined parameters.
  4. Performance Qualification (PQ): Validate that the Parts Washer performs effectively in cleaning equipment parts.

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

Acceptance Criteria Governance: Acceptance criteria will be established based on the User Requirement Specification (URS) and aligned with Annex 11 requirements.

Calibration/PM Governance: The Parts Washer will undergo regular calibration and preventive maintenance as per the manufacturer’s recommendations and internal policies.

See also  Tablet Deduster – Traceability Matrix (URS ↔ Tests)

Change Control Triggers: Any changes to the equipment, process, or cleaning methods will trigger a formal change control process, requiring re-evaluation of validation status.

Revalidation Triggers and Periodic Review: Revalidation will be conducted every 24 months or whenever there is a significant change in the equipment or process.

Records/Attachments List:

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

Also Check:

Vacuum Tray Dryer – IQ Protocol

Installation Qualification Protocol for Vacuum Tray Dryer in Solid Dosage Form Document Number: IQ-VD-001 Version: 1.0 Effective Date: [Insert Date] Prepared By: [Insert Name] Approved By: [Insert Name] Objective The objective of this Installation Qualification (IQ) protocol is to verify…

Barcode Scanner (GMP) – Traceability Matrix (URS ↔ Tests)

URS ID URS Statement Risk (H/M/L) DQ Test Ref IQ Test Ref OQ Test Ref PQ Test Ref Evidence/Record Result URS-001 The barcode scanner must accurately capture data for identity verification. H DQ-001 IQ-001 OQ-001 PQ-001 Data capture logs URS-002…

Pneumatic Conveying (Dense Phase) – DQ Protocol

Design Qualification Protocol for Pneumatic Conveying System in Solid Dosage Form Production Document Number: DQ-OSD-PC-001 Version: 1.0 Effective Date: [Insert Date] Reviewed By: [Insert Name] Approval Date: [Insert Date] Objective: To validate the Pneumatic Conveying System for contained transfer of…