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10th December 2020 Article by Huai Nyin (Grace) Yow AMIChemE, Steve Marshall, Scott Davies, Sonia Ganatra and John Hancock CEng FIChemE Huai Nyin (Grace) Yow and colleagues discuss the engineering challenges specific to pharmaceutical projects I S engineering a pharmaceutical project more challenging than for other industries? An engineering project, generally, has a defined development path: conception; design (P&IDs, design calculations, equipment selection, 3D-model and software writing); procurement; build; installation; commissioning; operational testing; and lastly but not least, client handover. Engineering of a pharmaceutical project is very similar, with added detail of validation activities and compliance for regulatory approval. This is because ultimately the drug, and its production process, must be given the regulatory approval stamp before the drug can help its intended users. And by definition, a regulatory-approved drug has successfully passed all testing and clinical trials, with the results independently assessed to confirm that the drug is safe and effective for its intended users.