I met Prof. Friedli some years ago in France and I was impressed about his competence and open mind set so I was curious to study the research publication of Prof. Thomas Friedli and his team from University of St. Gallen. They published their results of the 2nd Year report “FDA Quality Metrics Research” in NOV 2018 – metrics fda.The Year 2 research aim is to examine the validity of the Pharma Production System Model (PPSM) developed by University St. Gallen.
One of the major key findings of Year 1 were:
– Pharma Quality System (PQS) Excellence level requires a high PQS Effectiveness & PQS Efficiency – Companies with a high PQS Effectiveness have a significantly higher Cultural Excellence.
My take away is that Sites with a high performing PQS do have a high Cultural Excellence Level and if you combine it with a high performance OTIF (Service Level Delivery) you will master it.
Need more food for thoughts – here you go!
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