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 features are operational and meet acceptance criteria.
4.4 Performance Verification
4.4.1 Execute performance tests to demonstrate that the equipment performs consistently and reliably under normal operating conditions.
4.4.2 Evaluate performance data and compare results against predefined performance criteria to ensure compliance and functionality.
4.5 Validation and Qualification
4.5.1 Validate equipment performance through documented protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
4.5.2 Obtain QA approval for commissioning reports and validation protocols before operational use.
5) Abbreviations, if any
SOP – Standard Operating Procedure
IQ – Installation Qualification
OQ – Operational Qualification
PQ – Performance Qualification
6) Documents, if any
Commissioning Plan
Installation Qualification (IQ) Protocol
Operational Qualification (OQ) Protocol
Performance Qualification (PQ) Protocol
7) Reference, if any
Equipment manufacturer’s installation and commissioning manuals
Company-specific commissioning and validation guidelines
8) SOP Version
Version 1.0
