Pharmaceutical Engineering May/June Issue Preview: "Defining Holistic Asset Criticality
to Manage Risk"
by David J. Mierau, PE, CMRP, Sr. Reliability Engineering SME, Life Cycle Engineering
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The pharmaceutical and biotech industries have a wealth of information related to risk-based practices for validation, qualification and commissioning of processes and equipment. These approaches typically focus on the impact of an asset to product or raw material Strength, Identity, Purity and Quality (SISPQ). However, there is also significant value in understanding the holistic potential impact an asset carries.
This article illustrates how risks to safety, quality and productivity can be managed through asset
control strategies, which are created based on specific asset criticality and failure modes.
"Statistically Determined Acceptance Criteria and Sampling Plans for PPQ"
by Mark D. Johnson, Principal Research Statistician, AbbVie, Inc.
Download Presentation ( 1 MB)
In the FDA's Process Validation Guidance from January 2011, the concept of "statistics" is mentioned 15
times, showing that more statistical thinking is expected in validation. This presentation, from the 2013
ISPE Process Validation Conference, explores how statistics can result in a higher degree of assurance that a
high percentage of the population is within specification and a population parameter is within specification.
This topic will also be discussed during the upcoming ISPE Statistician Forum.
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