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.”
Posted by Dr. Tim Sandle
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