Standard Operating Procedure for Equipment Performance Qualification Protocols
1) Purpose
The purpose of this SOP is to define the procedures for conducting equipment performance qualification (PQ) protocols to ensure that manufacturing equipment used for dental dosage forms, including pastes, gels, and mouthwashes, consistently performs according to specified requirements and regulatory standards.
2) Scope
This SOP applies to all equipment and machinery involved in the pharmaceutical manufacturing processes for dental dosage forms. It includes protocols for establishing and verifying equipment performance capabilities, reliability, and compliance with regulatory requirements throughout its operational lifecycle.
3) Responsibilities
The Engineering Department is responsible for developing, executing, and documenting equipment PQ protocols. The Quality Assurance (QA) Department provides oversight to ensure protocols comply with regulatory standards. Production and Maintenance Departments support PQ activities by providing operational data, maintenance records, and technical support.
4) Procedure
4.1 Protocol Development
4.1.1 Define the purpose and objectives of the PQ protocol, specifying equipment performance criteria, test methods, acceptance criteria, and regulatory requirements.
4.1.2 Review equipment specifications, operational parameters, and intended use to establish protocol requirements.
4.1.3 Obtain necessary approvals for protocol development, including input from stakeholders and regulatory authorities.
4.2 Protocol Execution
4.2.1 Prepare the equipment for testing by ensuring it is clean, calibrated, and operating under normal production conditions.
4.2.2 Execute the PQ protocol according to defined test procedures, including performance tests, operational tests, and worst-case scenarios.
4.2.3 Record test data, observations, deviations, and any corrective actions taken during protocol execution.
4.3 Data Analysis and Reporting
4.3.1 Analyze test results to verify equipment performance against acceptance criteria and regulatory requirements.
4.3.2 Prepare a PQ report summarizing protocol objectives, test methods, results, deviations, and conclusions.
4.3.3 Obtain approval of the PQ report from QA and relevant stakeholders as required.
4.4 Protocol Review and Revision
4.4.1 Conduct periodic reviews of PQ protocols to incorporate updates based on equipment modifications, regulatory changes, or performance improvement initiatives.
4.4.2 Revise protocols as necessary to enhance clarity, effectiveness, and compliance with current standards.
4.4.3 Document protocol revisions, approvals, and implementation dates.
4.5 Documentation and Record-Keeping
4.5.1 Maintain comprehensive records of all PQ protocols, reports, approvals, and related documentation in a secure and accessible manner.
4.5.2 Ensure documentation integrity through version control, document retention policies, and data management practices.
5) Abbreviations, if any
SOP – Standard Operating Procedure
PQ – Performance Qualification
QA – Quality Assurance
6) Documents, if any
Equipment Specifications
PQ Protocols
PQ Reports
Approval Records
7) Reference, if any
Good Manufacturing Practices (GMP) guidelines
International Organization for Standardization (ISO) standards for equipment qualification
Regulatory requirements for equipment performance validation
8) SOP Version
Version 1.0
