Standard Operating Procedure for Equipment Installation Qualification

1) Purpose

The purpose of this SOP is to ensure that all equipment used in the manufacturing of dental dosage forms is installed correctly according to the manufacturer’s specifications and regulatory requirements.

2) Scope

This SOP applies to all equipment used in the manufacturing process of dental pastes, gels, and mouthwashes within the pharmaceutical industry.

3) Responsibilities

The Engineering Department is responsible for performing the installation qualification. The Quality Assurance (QA) Department is responsible for reviewing and approving the IQ protocol and report.

4) Procedure

4.1 Preparation

4.1.1 Ensure all necessary documentation, including equipment manuals and specifications, are available.

4.1.2 Verify that the installation area meets the requirements specified by the manufacturer.

4.2 Installation Verification

4.2.1 Unpack and inspect the equipment for any damage during transit.

4.2.2 Verify the equipment identification number and model against the purchase order and delivery note.

4.2.3 Install the equipment according to the manufacturer’s instructions.

4.3 Documentation

4.3.1 Record the installation details, including location, utilities connections, and calibration settings, in the IQ protocol.

4.3.2 Attach any calibration certificates and manuals to the IQ protocol.

4.4 Approval

4.4.1 Submit the completed IQ protocol to the QA Department for review and approval.

4.4.2 Store the approved IQ protocol in the equipment qualification file.

5) Abbreviations, if any

IQ – Installation Qualification

6) Documents, if any

IQ Protocol

Equipment Manuals

Calibration Certificates

7) Reference, if any

Current Good Manufacturing Practices (cGMP) guidelines

8) SOP Version

Version 1.0