Process Validation
Life Science Consulting
August 31, 2016
How Much Can You Afford NOT to Know?
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...
Process Validation
Life Science Consulting
June 29, 2016
CPV versus APR, What’s the Difference?
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...
FDA
PQ
December 15, 2015
Operational Qualifications "Worst Case" Conditions
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...
Process Validation
Life Science Consulting
October 18, 2015
Which Is Best? Regression versus Control Charting
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...
Process Validation
Life Science Consulting
July 15, 2015
Business Sustainability: A Case for Process Validation
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...
Process Validation
Life Science Consulting
June 10, 2015
Mergers, Acquisitions and Consolidations: Whose Validation Standards Do I Use?
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...
Process Validation
Life Science Consulting
December 31, 2014
Where are the Numbers? Coding Test Results to Enhance the Analysis of Qualitative Data
Introduction A key prerequisite activity for any successful process validation is process characterization. Process characterization involves varying process inputs such as raw material properties,...
Process Validation
Life Science Consulting
December 15, 2014
Continued Cleaning Effectiveness: What Are You Doing? - Part II
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...
Process Validation
Life Science Consulting
November 24, 2014
Continued Cleaning Effectiveness: What Are You Doing?
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...