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August 31, 2016
The Regulatory Guidance embodied by ICHQ8 through (soon to be written) ICHQ12 tells us in no uncertain terms that we must protect the patient across the product lifecycle by assuring quality based on...
June 29, 2016
As an outcome of the 2011 Food and Drug Administration Process Validation Guidance, there has been ever increasing interest in the pharmaceutical industry to establish formal Continued Process...
December 15, 2015
Operational Qualifications "Worst Case" Conditions: A common principle in Operational Qualification (OQ) studies is to challenge processes under worst case conditions. A “worst case” condition or set...
October 18, 2015
I was recently asked to review a report summarizing the historic performance of a pharmaceutical process. The report consisted of the usual data tables and charts, but one thing caught my eye: data...
July 15, 2015
Business sustainability is an often heard buzz phrase, but how does it apply when a costly process validation is imminent? Process validation is not only a regulatory compliance issue; it is also a...
June 10, 2015
If you are like the majority of those who have worked in the biotechnology and pharmaceutical industry for at least the last five years, your company has been part of a merger, acquisition or some...
December 31, 2014
Introduction A key prerequisite activity for any successful process validation is process characterization. Process characterization involves varying process inputs such as raw material properties,...
December 15, 2014
My last blog focused on the industry trends concerning cleaning validation verification. Through a quick poll we found that out of twenty-three respondents, approximately fifty (50) percent are doing...
November 24, 2014
Recently I was asked by a client whether they should continue to do Re-Qualifications or change to Continued Process Verification on their qualified cleaning circuits. To answer this, the factors to...