Most pharmaceutical companies today handle facility commissioning and validation separately. A new approach to engineering projects, Outcome CV, developed by the engineering firm Syska Hennessy Group (New York) and BioMetics, Inc. (Waltham, Mass.) integrates the two processes in an approach that, Outcome CV's developers say, can eliminates costly delays. The problem with the conventional model, they say, is that commissioning typically occurs after construction and before validation. Since the commissioning process starts before validation, it doesn't support it.
Developers began to work on the Outcome CV methodology, which was formally launched at the Interphex conference in New York in March, after noticing recurring patterns in commissioning and validation problems. At one East Coast pharmaceutical manufacturing facility, for example, validation costs budgeted at $800,000 actually reached $2.4 million, and requiring an extension of 20 months. For the manufacturer, these translated into $16 million in lost drug revenues and nearly two years lost on the patent expiration clock.
Outcome CV dictates that validation be considered as early as possible in the planning stage, and involve members from different functional silos, Syska Hennessy principal Paul Liesman says. The integrated commissioning and validation process then continues during the design phase, when commissioning/validation plan and protocols are developed along with drawings and specifications. The integrated process then continues during construction, Liesman says, ensuring a link between design operation and utilities and process to production, and during operation and maintenance turnover, when final documents are turned over to the owner and standard operating procedures and training programs are developed. Liesman says the new integrated process is expected to speed validation and eliminate the 20-25% error rate found in facility systems.