Design Qualification Protocol for CIP Skid in Nasal & Otic Product Manufacturing

Objective

The objective of this Design Qualification (DQ) protocol is to ensure that the CIP Skid used for cleaning tanks and pipelines in the production of nasal and otic products meets all specified requirements and performs as intended.

Scope

This protocol applies to the CIP Skid system used in the production and cleaning areas for nasal and otic products, both sterile and non-sterile. It covers validation requirements as per URS Annex 11 and Annex 15.

Responsibilities

• Validation Team: Responsible for executing the DQ protocol and documenting results.
• Quality Assurance: Responsible for reviewing and approving the DQ protocol.
• Equipment Owners: Responsible for ensuring the equipment is maintained and available for validation.

Prerequisites

• URS (User Requirement Specification) for CIP Skid.
• Installation Qualification (IQ) completed.
• Operational Qualification (OQ) completed.

Equipment Description

The CIP Skid is a cleaning-in-place system designed to clean tanks and pipelines used in the production of nasal and otic products. It includes features for temperature, conductivity, flow, and audit trail logs to ensure compliance with regulatory requirements.

Test Plan

Detailed Test Cases

Test Case T1: Verify Temperature Control

Procedure: Monitor the temperature during the CIP cycle and ensure it remains within the specified limits.

Acceptance Criteria: Temperature must remain within the defined range of [insert range].

Evidence: Review temperature log data for compliance.

Test Case T2: Verify Conductivity Measurement

Procedure: Measure conductivity at various points during the CIP cycle.

Acceptance Criteria: Conductivity must be within [insert limits].

Evidence: Conductivity log data must be reviewed and validated.

Test Case T3: Verify Flow Rate

Procedure: Measure the flow rate during the cleaning process.

Acceptance Criteria: Flow rate must be within [insert limits].

Evidence: Flow rate log data must be reviewed and validated.

Test Case T4: Verify Audit Trail Logs

Procedure: Review the audit trail logs for completeness and accuracy.

Acceptance Criteria: All logs must be complete and accurately reflect the cleaning process.

Evidence: Audit trail log data must be reviewed and validated.

Deviations

Any deviations from the acceptance criteria must be documented and investigated. Corrective actions must be taken and documented.

Approvals

Prepared by: _______________________ Date: ____________

Approved by: _______________________ Date: ____________