Standard Operating Procedure for Requalification of Equipment and Systems
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish procedures for the requalification of equipment, utilities, facilities, and systems within the pharmaceutical manufacturing facility to ensure continued compliance with regulatory requirements and consistent product quality.
2) Scope
This SOP applies to all equipment, utilities, facilities, and systems that require requalification following installation, significant modification, or at defined intervals as per regulatory guidelines and internal policies.
3) Responsibilities
– Validation Manager: Oversees the requalification program and ensures adherence to SOP and regulatory requirements.
– Quality Assurance (QA) Department: Reviews and approves requalification protocols and reports to verify compliance with established criteria.
– Engineering and Maintenance Teams: Conduct requalification activities and maintain equipment and systems as per manufacturer’s recommendations.
4) Procedure
4.1 Requalification Planning
4.1.1 Develop a requalification schedule based on risk assessment, regulatory requirements, and equipment/system criticality.
4.1.2 Identify requalification requirements for each equipment, utility, facility, or system based on historical data and current usage.
4.2 Requalification Protocol Development
4.2.1 Prepare requalification protocols outlining test procedures, acceptance criteria, sampling plans, and responsibilities.
4.2.2 Include a validation approach that addresses potential risks and deviations during requalification activities.
4.3 Requalification Execution
4.3.1
4.3.2 Document all requalification activities, observations, deviations, and corrective actions taken during the requalification process.
4.4 Requalification Reporting
4.4.1 Compile requalification results and data into comprehensive requalification reports for each equipment, utility, facility, or system.
4.4.2 Obtain approval of requalification reports from the QA department and relevant stakeholders before closure.
4.5 Requalification Review and Approval
4.5.1 Review requalification reports for completeness, accuracy, and compliance with requalification protocols and acceptance criteria.
4.5.2 Archive approved requalification reports and associated documentation for future reference and regulatory inspections.
4.6 Documentation
4.6.1 Maintain records of requalification schedules, protocols, reports, deviations, and approvals in a controlled document management system.
4.6.2 Ensure that all requalification-related documentation is accessible, up-to-date, and compliant with SOP and regulatory requirements.
4.7 Reporting
4.7.1 Prepare periodic reports summarizing requalification activities, including compliance status, deviations identified, and corrective actions taken.
4.7.2 Submit reports to the QA department for review, approval, and archiving.
5) Abbreviations, if any
– SOP: Standard Operating Procedure
– QA: Quality Assurance
6) Documents, if any
– Requalification Protocols
– Requalification Reports
– Requalification Schedule
7) Reference, if any
– FDA Guidance for Industry: Equipment Qualification under the CGMP Requirements
– ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
8) SOP Version
Version 1.0