Validation and Engineering

NCBIO, its Biotech Manufacturers Forum, and the Professional Engineers of North Carolina (PENC) have recently worked together to clarify whether and what aspects of pharmaceutical manufacturing validation constitute the practice of engineering. Generally, the partners have concluded that validation activities, in and of themselves, do not constitute the practice of engineering. However, the process of commissioning new manufacturing systems and equipment does involve engineering practice. Corrective actions that are prompted by validation activities may also involve the practice of engineering if the corrective action involves redesign or recommissioning of system components.

For a further information on the relationship between pharmaceutical validation and engineering practice, see the following documents.