Equipment, Facility and Utility Qualification
CTI uses the ASTM Standard E2500-07 approach for equipment, facility and utility qualification. ASTM E-2500 satisfies international regulatory expectations for regulated-manufacturers to fulfill the necessary requirements to consistently manufacture product within defined quality specifications. ASTM E-2500-07 addresses for the following areas:
- Controlled process performance
More importantly, ASTM E-2500-07 achieves these objectives at improved value over a traditional approach to facility, utility and equipment qualification.
How ASTM Standard E2500-07 Works
ASTM Standard E2500-07, was issued in May 2007, appropriately titled as “Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.” Unlike a traditional qualification approach, E2500-07 unleashes the power of a risk-based science-based thinking approach to identify specifications, design, and verification needs for new and existing pharmaceutical and biopharmaceutical manufacturing systems, such as the following:
- Processing facilities
- Manufacturing equipment
- Laboratory instruments
- Supporting utilities
- Process monitoring and control systems
- Automation systems
ASTM Standard E2500-07 is a consensus standard, recognized by the International Society of Pharmaceutical Engineers (ISPE) and worldwide regulatory bodies. When ASTM E-2500-07 is coupled with ISPE guidelines, they synergize to provide a well-defined structure and framework for building an engineering-centric quality management system. The approach is so simple that it guides the user through management and implementation of business-critical commissioning, qualification, and validation projects associated with facility, equipment, and utility systems.
This results in a practical approach to commissioning, qualification, and validation activities that is streamlined, requiring only the verification and testing activities that add value. System verification is engineering-centric in ASTM E2500-07. Engineers perform verification of the engineering deliverables while Quality Assurance assumes responsibility for performance requirements that directly impact site operations and quality management. In this way, Quality Assurance’s role is less burdensome, allowing Engineering to act in a Quality Assurance role to assure compliance to technical system requirements.
This new approach shifts qualification responsibilities and activities to the company’s corporate engineering group and support organizations (such as Engineering, Maintenance, Project engineering, as well as design firms, equipment vendors, construction/engineering contractors and architects). The result is a focus on the critical aspects, which reduces overall QA burden in a construction project.
The ISPE guidelines apply to all manner of pharmaceutical products (i.e., aseptic solutions, biopharmaceuticals, API, solid dosage forms, etc.) and technologies (i.e., CIP, SIP, WFI systems, sterilization systems, filtration systems, etc.). Because this approach is risk-based and science-based, this approach is also appropriate for qualification of medical device manufacturing systems.
In a computerized manufacturing system, ISPE’s commissioning and qualification guideline and GAMP guideline are both currently being revised to harmonize with the ASTM E2500-07 standard and to also provide more prescriptive guidance on how to meet the intent of the standard and current FDA expectations for commissioning, qualification, and validation.
This is a more practical approach to facility, equipment, and utility qualification, and we believe it is a powerful tool that will ensure that manufacturing systems are suitable for intended use while at the same time driving costs down. It aligns with risk management requirements in the ISO standards, which assure product quality, and patient safety. Let Compliance Team show you how to make the ASTM E-2500-07 approach work in your organization!