April 9, 2014
Next week I’ll be in San Francisco conducting an ISPE training class on Risk Based Approach to GxP Process Control Systems. Attendees will include employees from a variety of regulated life cycle companies as well as FDA inspectors. The two-day course focuses on the application of GAMP® 5 guidance and principles to the validation of process control systems used in the manufacture of regulated drug and medical device products. This seems like a timely opportunity to re-visit the key GAMP® 5 concepts as they relate to establishing a compliant system validation methodology.
Concept 1: Product and Process Understanding
Understanding the product manufacturing or business process for which a computer system is being implemented is a critical first step to ensure the system meets its intended purpose. For product manufacturing processes, automation control systems are frequently required to maintain Critical Process Parameters (CPPs) in order to ensure product related Critical Quality Attributes (CQAs) are achieved. Systems that manage and maintain electronic data for regulated business processes must conform to critical record management requirements for the process. In both cases documented system requirements and specifications are the primary mechanisms for ensuring that product and process understanding is captured and reflected in the final system.
Concept 2: Life Cycle Approach
A defined system life cycle provides an organized and controlled approach to plan, design, develop, verify, implement, and ultimately retire the system. If properly implemented, a life cycle approach not only ensures system compliance, but can also improve overall system quality and effectiveness. A well planned and implemented life cycle process places a strong emphasis on system design in order to identify issues early on where they are less costly to correct . While GAMP emphasizes distinct life cycle phases, it does not preclude the use of flexible approaches in the system development process.
Concept 3: Scalable Life Cycle Activities
While a defined life cycle provides an effective framework for system development, it should not attempt to enforce a one-size-fits-all process. Computer systems used to support regulated manufacturing and business processes vary greatly in complexity, scope, and potential impacts on patient safety, product quality, and regulated data integrity. Incorporating scalability into the life cycle allows for the adjustment of activities and deliverables to fit the risk associated with the system and supported processes.
Concept 4: Science Based Quality Risk Management
The application of risk assessment to the overall life cycle supports the ability to scale activities relative to computer system impact and complexity. As the concept verbiage suggests, risk assessment should be based upon objective, scientific/technical evaluation of the system being implemented, particularly with regard to patient safety, product quality, and data integrity. Risk should be assessed and managed throughout the life cycle of the system, and in varying levels of detail from high level architecture through individual functional capabilities in the case of high risk systems.
Concept 5: Leverage Supplier Involvement
Finally, with an emphasis on science based risk management, and reliance on technical experts to assist in the assessment process, opportunities exist to leverage contributions from suppliers and vendors in the implementation of regulated computer systems. Assuming the adoption of good system and engineering practices, and internal quality management systems by technology suppliers, significant reductions in redundant testing and documentation can be achieved by relying on vendor provided support. With proper controls and oversight this can enable many life cycle and validation activities to be completed more efficiently while maintaining a high level of compliance.
These GAMP® 5 concepts provide a great foundation for developing and establishing any compliant and effective computer system validation framework.
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