In this article, we discuss the value of a properly focussed analysis of engineering risk in the design of automated manufacture and test systems for pharmaceutical applications, and illustrate our case with real examples seen in the manufacture of medical devices and in the design of machines used in drug development.

In bringing new pharmaceutical products or medical devices to market, producers must adhere to rigorously documented procedures overseen by regulatory bodies, as embodied in for example ASTM E-2500 [1] and GAMP 5 [2], as well as maintaining a self-regulated quality system as in ISO 13485/ISO 9001.

Typically, producers are dependent on third parties to supply instruments and systems for manufacture. The producer must demonstrate that their production process, including these third-party elements, meets necessary standards often involving formal validation. Consequently, producers expect that any third-party systems must themselves be demonstrated to be built to purpose, compliant to the same methodologies mentioned above.

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