Ointment Tube Filling Machine (Sterile/Controlled) – OQ Protocol

Document Number: OQ-ETFM-001

Version: 1.0

Effective Date: 2023-10-01

Review Date: 2024-10-01

Operational Qualification Protocol for Ointment Tube Filling Machine

Objective: To establish and document the operational qualification of the Ointment Tube Filling Machine to ensure it meets specified operational requirements for filling ophthalmic tubes.

Scope: This protocol applies to the Ointment Tube Filling Machine used in the Production/Packaging area for the filling of sterile ophthalmic products, including eye drops and ointments.

Responsibilities:

  • Validation Team: Responsible for executing the OQ protocol and documenting results.
  • Quality Assurance: Responsible for reviewing and approving the OQ documentation.
  • Production Staff: Responsible for operating the equipment during the OQ process.

Prerequisites:

  • Installation Qualification (IQ) must be completed and approved.
  • All personnel involved must be trained on the equipment operation.
  • Equipment must be cleaned and sanitized per SOP.

Equipment Description: The Ointment Tube Filling Machine is designed for the sterile filling of ointments into ophthalmic tubes. It operates under controlled conditions to ensure product integrity and compliance with regulatory standards.

Test ID Procedure Acceptance Criteria Evidence
OQ-001 Verify fill weight accuracy Fill weight within ±5% of target Calibration records, weighing logs
OQ-002 Check sealing integrity No leaks detected under pressure test Pressure test results
OQ-003 Conduct reject audit trail verification Audit trail shows no discrepancies Audit trail report
See also  Distillation Unit / Distillation Column – Qualification Execution Checklist

Detailed Test Cases:

Test Case OQ-001: Verify Fill Weight Accuracy

  • Procedure: Fill a set number of tubes and weigh each tube.
  • Expected Result: All filled tubes should have a fill weight within ±5% of the target.
  • Data Integrity Check: Ensure all weights are recorded in the electronic batch record (EBR).

Test Case OQ-002: Check Sealing Integrity

  • Procedure: Perform a pressure test on sealed tubes.
  • Expected Result: No leaks should be detected.
  • Data Integrity Check: Document pressure test results in the EBR.

Test Case OQ-003: Conduct Reject Audit Trail Verification

  • Procedure: Review the audit trail for any reject entries.
  • Expected Result: Audit trail shows no discrepancies.
  • Data Integrity Check: Ensure audit trail data is securely stored and retrievable.

Deviations:

Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed if necessary.

Approvals:

Validated by: ____________________ Date: ____________

Approved by: ____________________ Date: ____________

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