Standard Operating Procedure for Equipment Commissioning

1) Purpose

The purpose of this SOP is to establish procedures for the commissioning of new equipment used in the manufacturing of dental dosage forms, ensuring that equipment is installed, tested, and validated according to specified requirements before operational use.

2) Scope

This SOP applies to the commissioning of all new equipment used in the production, testing, and control of dental pastes, gels, and mouthwashes within the pharmaceutical industry.

3) Responsibilities

The Engineering Department is responsible for coordinating and executing equipment commissioning activities. Quality Assurance (QA) personnel and production supervisors are responsible for reviewing and approving commissioning protocols and reports.

4) Procedure

4.1 Pre-Commissioning Preparation

4.1.1 Develop a commissioning plan outlining activities, timelines, and responsibilities for equipment installation and testing.

4.1.2 Verify that all necessary utilities, supplies, and components are available for equipment installation.

4.2 Installation Verification

4.2.1 Conduct a physical inspection to ensure that the equipment is delivered as per specifications and that all components are intact and undamaged.

4.2.2 Verify that the equipment is installed correctly according to manufacturer’s guidelines and site specifications.

4.3 Functional Testing

4.3.1 Perform functional tests to verify that equipment operates according to predefined specifications and operational parameters.

4.3.2 Document and review test results to confirm that all equipment functions and