Standard Operating Procedure for Equipment Operational Qualification

1) Purpose

The purpose of this SOP is to ensure that all equipment used in the manufacturing of dental dosage forms operates according to the manufacturer’s specifications and meets all 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 conducting the operational qualification. The Quality Assurance (QA) Department is responsible for reviewing and approving the OQ protocol and report.

4) Procedure

4.1 Preparation

4.1.1 Ensure that the equipment has successfully passed the Installation Qualification (IQ).

4.1.2 Gather all necessary documentation, including the OQ protocol and manufacturer’s operational specifications.

4.2 Operational Testing

4.2.1 Conduct operational tests as outlined in the OQ protocol to verify that the equipment performs according to the manufacturer’s specifications.

4.2.2 Record all operational parameters, such as temperature, pressure, and speed, as applicable.

4.2.3 Perform tests under normal operating conditions and also under stress conditions, if specified.

4.3 Documentation

4.3.1 Document all test results in the OQ protocol, including any deviations and corrective actions taken.

4.3.2 Attach any relevant data, such as charts or graphs, to the OQ protocol.

4.4 Approval

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

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

5) Abbreviations, if any

OQ – Operational Qualification

6) Documents, if any

OQ Protocol

Manufacturer’s Operational Specifications

7) Reference, if any

Current Good Manufacturing Practices (cGMP) guidelines

8) SOP Version

Version 1.0