Standard Operating Procedure for Requalification of Equipment and Systems
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to define procedures for the periodic requalification of equipment and systems within the pharmaceutical manufacturing facility to ensure continued compliance with regulatory requirements and maintain product quality and safety.
2) Scope
This SOP applies to all equipment and systems critical to manufacturing, testing, and storage activities within the pharmaceutical facility. It covers procedures for requalification planning, execution, and documentation.
3) Responsibilities
– Quality Assurance (QA) Department: Oversees the implementation of the SOP and ensures compliance with regulatory requirements.
– Validation Department: Executes requalification protocols and maintains requalification schedules.
– Engineering Department: Provides technical support for equipment requalification activities.
4) Procedure
4.1 Requalification Planning
4.1.1 Establish a requalification schedule based on equipment criticality, usage frequency, and regulatory requirements.
4.1.2 Define acceptance criteria and requalification protocols for each equipment/system category.
4.2 Requalification Execution
4.2.1 Perform pre-execution checks to ensure equipment readiness for requalification activities (e.g., cleaning, calibration).
4.2.2 Execute requalification protocols, including performance testing and operational qualification (OQ), as per approved procedures.
4.3 Data Analysis and Reporting
4.3.1 Analyze requalification data to verify equipment/system performance against acceptance criteria.
4.3.2 Prepare requalification reports documenting results, deviations, and conclusions.
4.4 Deviation Management
4.4.1 Investigate any deviations encountered during requalification activities using appropriate root cause analysis tools.
4.4.2 Implement corrective actions and preventive actions (CAPA) as necessary to address identified issues.
4.5 Requalification Approval and Review
4.5.1 Obtain approvals for requalification reports from designated personnel (e.g., QA, Validation).
4.5.2 Review and verify completeness of requalification documentation before final approval.
4.6 Documentation
4.6.1 Maintain comprehensive records of all requalification activities, including protocols, reports, and deviation investigations.
4.6.2 Ensure that all records are reviewed and approved by the QA department.
4.7 Reporting
4.7.1 Prepare summary reports on requalification status, including compliance with requalification schedules and acceptance criteria.
4.7.2 Submit reports to the QA department for review, approval, and archiving.
5) Abbreviations, if any
– QA: Quality Assurance
– SOP: Standard Operating Procedure
– OQ: Operational Qualification
– CAPA: Corrective and Preventive Actions
6) Documents, if any
– Requalification Protocols
– Requalification Reports
– Deviation Investigation Reports
7) Reference, if any
– FDA Guidance for Industry: Process Validation: General Principles and Practices
– EU GMP Annex 15: Qualification and Validation
8) SOP Version
Version 1.0
