Defining Holistic Asset Criticality To Manage Risk In Biopharma

By David J. Mierau, PE, CMRP

The pharmaceutical and biotech industries have a wealth of information published related to risk-based practices for validation, qualification and commissioning of processes and equipment. However, these approaches typically focus exclusively on the impact of an asset to product or raw material SISPQ Strength, Identity, Safety, Purity, and Quality (SISPQ). While this is an appropriate focus area for making medicines and vaccines, there is significant business value in understanding the holistic potential impact an asset carries.

Successful pharmaceutical and biotech operations share the same foundation as other manufacturing operations: safety, quality and productivity. People within an organization use established processes (e.g., procedures, standards, programs, etc.) to achieve a stable asset performance level. As an example: manufacturing production planners use their current sales and operations plan to create a base schedule for operations so that customer orders can be met and desired inventory levels are maintained. Having some balance across all three areas of safety, quality and productivity is necessary – take away one of these aspects and the operation will not be successful. Pharmaceutical and biotech operations typically have robust quality and Process Safety Management (PSM) systems, but have not developed equally valuable productivity systems.

This Article is published with permission from the International Society of Pharmaceutical Engineering (ISPE), and Pharmaceutical Engineering Magazine