Clarkston survey: Leveraging process analytical technology

In a survey conducted by Clarkston Consulting, incompatible or unreliable technology and lack of organizational readiness were the most commonly cited hurdles to implementation of process analytical technology (PAT). Clarkston surveyed 10 pharmaceutical companies in April 2004 to gauge their activity following the draft guidance of the U.S. Food and Drug Administration (FDA) on PAT. Despite the hurdles, all of the companies believed that PAT would give their companies moderate or significant advantages. A major theme from the results, Clarkston noted, was that PAT is as much about organizational improvement as it is about quality.

Clarkston asked the surveyed companies to give advice to others starting to evaluate and implement PAT. The suggestions focused on organizational impact, cross-functional organizational ownership and viewing PAT as part of a broader improvement program, rather than as pure technology. Clarkston also offered advice and a four-tiered path that they expect most companies to take in working toward full PAT benefits.

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