Daniel Torok is a Senior Drug Substance Consultant at Design Space InPharmatics. With a background as a process chemist and years of experience in process development and API Operations, Daniel brings a unique perspective on CMC and the pharmaceutical industry. Today, Daniel discusses the vital role that trust plays in the relationship between a sponsor company and a contract manufacturing organization (CMO) as a Person In-Plant. He provides real-world examples of Person in-plant visits he’s conducted. Finally, he lists some interesting facts, myths and stories about CMOs.
“The White Coat Effect is real. Even in a good facility it’s absolutely real. When operators find out the client is coming they behave very differently and the level of detail is much more.”
“Probably the most touching was I spent a lot of time on an API facility on the East Coast and, on the last day, their process chemist said, ‘I want to thank you. You’re the first person in plant who’s ever actually helped me.”
“I warn them, ‘I’m gonna be there when you don’t really want me there.’”
“Just because you walk out the door of the plant and you go to the airport and get on the plane, it [the process] shouldn’t be done or finished for us.”
“I think one of the myths people have is that a CMO absolutely knows their equipment all the time and the process is going to be run the same every single time.”
“It changes, it’s going to be fluid in this industry. Things happen. Things go wrong.”
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