Design Qualification Protocol for Inline Sifter Equipment in Solid Dosage Form Production

Objective

The objective of this Design Qualification (DQ) Protocol is to establish documented evidence that the Inline Sifter equipment is suitable for its intended use in the production of Solid Dosage Forms.

Scope

This protocol applies to the Inline Sifter used in the transfer line for sifting during the production of Solid Dosage Forms. It covers the assessment of the equipment’s design and its compliance with the User Requirements Specification (URS).

Responsibilities

• Validation Team: Responsible for executing the DQ protocol and documenting results.
• Quality Assurance: Responsible for reviewing and approving the DQ protocol.
• Engineering: Responsible for providing technical specifications and support for the Inline Sifter.

Prerequisites

All necessary documentation, including the User Requirements Specification (URS) and equipment specifications, must be available prior to executing this DQ protocol.

Equipment Description

The Inline Sifter is designed to ensure the effective sifting of powders during the transfer process. It operates continuously and is integrated within the production line to minimize manual handling and contamination risks.

Test Plan

Detailed Test Cases

Test Case T1: Verify Flow Rate

Procedure: Measure the flow rate of material passing through the Inline Sifter. Compare the measured flow rate against the specifications defined in the URS.

Expected Result: The flow rate should meet the specified criteria.

Test Case T2: Measure Differential Pressure

Procedure: Measure the differential pressure across the sifting screen during operation. Ensure that the readings are taken at defined intervals.

Expected Result: The differential pressure should remain within the acceptable limits established in the URS.

Deviations

Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed to address any identified issues.

Approvals

This protocol must be reviewed and approved by the appropriate personnel prior to execution. Signatures below indicate approval:

_________________________ [Validation Team Lead]

_________________________ [Quality Assurance]

_________________________ [Engineering Representative]