Standard Operating Procedure for Equipment Performance Qualification
1) Purpose
The purpose of this SOP is to ensure that all equipment used in the manufacturing of dental dosage forms performs consistently and reliably under actual production conditions.
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 Production Department is responsible for conducting the performance qualification. The Quality Assurance (QA) Department is responsible for reviewing and approving the PQ protocol and report.
4) Procedure
4.1 Preparation
4.1.1 Ensure that the equipment has successfully passed the Operational Qualification (OQ).
4.1.2 Prepare the PQ protocol, outlining the tests to be conducted and the acceptance criteria.
4.2 Performance Testing
4.2.1 Operate the equipment under actual production conditions to verify its performance.
4.2.2 Monitor and record critical process parameters, such as temperature, pressure, speed, and output.
4.2.3 Conduct multiple production runs to ensure consistency and reliability.
4.3 Documentation
4.3.1 Document all test results in the PQ protocol, including any deviations and corrective actions taken.
4.3.2 Attach any relevant data, such as production records and charts, to the PQ protocol.
4.4 Approval
4.4.1 Submit the completed PQ protocol to the QA Department for review and approval.
4.4.2 Store the approved PQ protocol in the equipment qualification file.
5) Abbreviations, if any
PQ – Performance Qualification
6) Documents, if any
PQ Protocol
Production Records
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
8) SOP Version
Version 1.0
