Former VP GSK Quality says Good Manufacturing Practice means "great mountains of paperwork"
...and he's not wrong!
Another industry insider
Now we hear from a fellow industry insider, Peter Savin. Peter kindly agreed to be an expert witness in Find It, File It, Flog It, contributing the piece that follows. This goes back to early 2015, before the collapse of the global regulatory system.
Prior to that, regulators said “jump” Pharma said “how high?”. Those days are long forgotten now.
“AN EXPERT WITNESS STATEMENT: PETER SAVIN
Hedley Q: What is your view on the industry’s lead from the regulators?
Peter A: First, many thanks for the opportunity to contribute to your quest and to comment on one of my biggest concerns for the future of our industry, namely the ever-increasing levels of mandate and documentation that we face in our daily operations. I need to say that the industry must grow up. It needs to move away from the child-parent relationship it has allowed to develop with the regulators. Waiting to be told what to do, by regulators and the ensuing consultants, isn’t a good sign of organizational c…