The main hope of ICH Q8-Q10 pertaining to operational excellence is to enable (bio)pharmaceutical companies to achieve product realization. The goal is to do so by establishing and maintaining a state of control and facilitating continual improvement while responding to pressures for efficiency and profitability improvements.
Peiyi Ko, Ph.D. and Peter Calcott, Ph.D. have written an interesting article on the subject for Pharmaceutical Online. Here is an extract:
“risk Management is open to individual interpretations and at times has varied and been time-consuming and not-informative for prioritization, re-inventing Risk assessments and leading to wasted resources and unsatisfactory outcomes. Therefore, it is proposed to use a quantitative approach with probabilistic calculations and monetized harm to account for occurrence and severity, respectively. Specifically, Failure modes and effects analysis (FMEA) is a classic tool for summarizing the modes of failure, factors causing these failures, and the likely effects of theses failures to reduce process complexity for management. It generates a risk priority score for a failure mode by multiplying the ratings for severity, occurrence, and detection.”
To access the article, see Pharmaceutical Online.
Posted by Dr. Tim Sandle