A focused simplification strategy will offer game-changing results in pharma operations. Regulation is inherently complex, and the bar seems to get higher with each passing year or with the issuing of new guidance.
Staying current is not easy and managing the inherent, ever-growing complexity can be a serious challenge. We highlight several ways to increase the efficiency of a production plant by helping operators execute tasks with greater consistency and confidence, and less effort.
A key principle is to ensure a reduction of cognitive load for personnel who work on the operational side of the business, helping them to complete their daily tasks with less effort and to a greater degree of success.
Another key principle is that the health of a company’s pharmaceutical quality system (PQS) has a significant impact on operational success. A plant’s PQS needs to be designed to support the volume of events a site must manage. Backlogs in investigations, change controls and CAPAs are symptomatic of poorly designed systems and potentially under-resourced operations. Focusing on backlog prevention needs to be an ongoing area of focus for management.
We suggest three simplification strategies that will make a significant difference and improve pharmaceutical plant operations: identifying and implementing GMP habits, institutionalising effective triage techniques, and pursuing SOP simplification.
