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“Play It As It Lies” – Decision making in early to mid-stage API development and manufacturing

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STUART G. LEVY
Principal, SGL Chemistry Consulting LLC, St. Arlington, Massachuetts, USA

The term “play it as it lies” refers to the requirement in golf, per the rules, to play the ball where it lands on the fairway, or in the rough, without any change to the overall situation (https://www.golflink.com/list_1703_play-as-lies-golf-rule.html).

There is aptness in this concept, as applied to pharmaceutical development.  In the current environment, API development is increasingly complex, compressed and tumultuous.  This has resulted in the prevailing need for chemical development and manufacturing leaders and scientists to “play it as it lies,” to deal with less than ideal circumstances by making hard decisions - prioritizing risk management and tolerating more risk in development programs.  This contrasts with the theoretically preferred approach, which is to proactively manage most, if not all, foreseen risks.

A number of factors are responsi ...