A | ADDITIONAL SAFETY CONSIDERATIONS CAN INCLUDE:
Orthogonal solutioning — e.g., employ a multivariate work process utilizing 5Whys/6S’s/etc. with safety protection layering/delayering while guided by less-ismore operating principle.
Less-Obvious, More-Opportunities — focus instead on, for example, Grade C/D and adjacent areas with inherently lower requirements and opportunities.
F-D-A — stay current by increasing Frequency of protocol reviews factoring in the Dynamic health authority and industry guidance. Also, be Agile to course adjustments. The impact of operating COGM (cost of goods manufactured) is estimated to be in the low fractional percentages. But although that impact varies, don’t just assume operating costs will increase. Instead, try refocusing on accelerating operational productivity initiatives, for example.
JACKS LEE is a global pharmaceutical executive with 25+ years of experience in vaccines, biopharmaceuticals, and small molecule pharmaceuticals.