Purpose:
The purpose of this SOP is to establish comprehensive guidelines for the effective implementation of the Quality Management System (QMS) in compliance with ISO 17025 and Current Good Manufacturing Practices (cGMP) regulations in the pharmaceutical industry.
Scope:
This SOP applies to all personnel involved in testing and calibration activities within the pharmaceutical laboratory, ensuring adherence to ISO 17025, cGMP, and other applicable regulatory requirements.
Responsibilities:
Quality Assurance (QA) Department:
- Oversees QMS implementation and compliance with ISO 17025, cGMP, and regulatory requirements.
- Manages document control, including records and data management.
- Facilitates communication of QMS updates and changes across departments.
Quality Control (QC) Department:
- Conducts audits to verify compliance with QMS, ISO 17025, cGMP, and regulatory requirements.
- Manages equipment calibration, maintenance, and validation to ensure accuracy and reliability.
All Employees:
- Follow QMS procedures and work instructions, maintaining adherence to regulatory standards.
- Communicate any deviations or non-conformities to QA for investigation and resolution.
Procedure:
1. Establishment of QMS Documentation:
- Develop QMS policies, procedures, and work instructions aligned with ISO 17025, cGMP, and regulatory requirements.
- Implement procedures for document control and record management to ensure data integrity and traceability.
2. Training:
- Provide targeted training on QMS, ISO 17025, cGMP, and relevant regulatory requirements based on personnel roles and responsibilities.
- Maintain training records and conduct regular competency assessments to ensure ongoing compliance and effectiveness.
3. Implementation of QMS Processes:
- Establish procedures for the control of purchased materials and services to ensure they meet required quality standards and specifications.
- Develop and implement equipment management procedures for calibration, maintenance, and validation to support accurate testing and calibration activities.
4. Control of Data and Data Analysis:
- Define procedures for data handling, analysis, and reporting to ensure accuracy, reliability, and compliance with regulatory requirements.
- Emphasize the importance of data integrity throughout the testing and calibration processes.
5. Monitoring and Measurement:
- Define Key Performance Indicators (KPIs) to monitor QMS effectiveness, compliance metrics, and process performance.
- Conduct regular internal audits to assess QMS compliance and effectiveness, including audit scope, frequency, and reporting procedures.
6. Management Review:
- Conduct periodic management reviews to evaluate QMS performance based on audit findings, KPIs, customer feedback, and regulatory updates.
- Use management reviews to identify opportunities for improvement, allocate resources, and drive continuous enhancement of the QMS.
7. Continuous Improvement:
- Implement Corrective and Preventive Actions (CAPA) procedures to address non-conformities, prevent recurrence, and promote continuous improvement.
- Foster a culture of quality and innovation through employee feedback, process enhancements, and adaptation to industry best practices.
Abbreviations:
- QMS – Quality Management System
- ISO 17025 – International Standard for testing and calibration laboratories
- cGMP – Current Good Manufacturing Practices
References:
Ensure compliance with ISO 17025:2017, cGMP regulations (21 CFR Part 211), and other relevant regulatory requirements throughout the implementation of this SOP.
Approval and Distribution:
This SOP shall be approved by the Quality Manager and communicated to all relevant personnel. It should be accessible within the QMS documentation system for reference and updates.