Commissioning and Qualification Hybrid Approach

EVENT: Interphex 2010              LOCATION: New York, NY, Javits Convention Center DATE: April 20 to 22, 2010 PRESENTER: Dave Dolgin, Senior Quality Program Manager, Abbott Park, Illinois, USA ABSTRACT: Commissioning and Qualification Hybrid Approach

The International Society for Pharmaceutical Engineering (ISPE) was developed in March 2001 as an engineering guide to perform commissioning and qualification activities. The development guide came from a concern about the increasing cost of validation activities that were driven in part by uncertainty about the requirements for regulatory compliance. Likewise, regulatory agencies are expecting that the industry implements a risk-based approach to the validation life-cycle management. Moreover, legacy systems may pose challenges when employing newly developed methodologies.

The case study will present a real-life example of a “hybrid” or “transitional” approach in the application of risk based C&Q. The specific project was an upgrade to an existing Uhlmann blister line. The example is a “hybrid” that utilizes Baseline Guide 5 terminology and expands on mechanisms of impact classification for system-level purposes (direct/indirect/no Impact), while incorporating risk assessments to link critical aspects and actual process risks. Additionally, an innovative and streamlined approach to the documentation of C&Q plans and risk assessments was demonstrated. Finally, the case study illustrates the benefits and challenges of applying a risk-based approach to legacy systems.

Highlights of the presentation:

• Assessment of major and minor changes
• Comparison between methods
• Utilization of a hybrid approach (using conventional qualification methods and risk based approach)
• Understanding risk assessment
• Benefits and challenges
• Lessons learned