8JUNE 2024TECH OUTLOOKIN MY OPINIONBy Robert Zanon, General Manager ­ Quality, ProbiotecHaving completed my bachelor of science in biotechnology back in 1992, I immediately planned to be on a plane with my friends on my way to the Bahamas to think about career and what I wanted to do with my life. However, before I could reach the airport and get onto that plane, I was offered a role for a small start-up company in the quality control lab. Believe it or not, I had not even applied for the job. It came to me through a friend. I cancelled my ticket, and my holiday was over in minutes. I was going nowhere! My destiny was being set. I was going into pharmaceutical manufacturing.The business I worked for was a start-up company involved in manufacturing sport/health/nutrition products. I entered a small lab having only a small HPLC unit with a chart recorder and some basic wet-type chemistry applications. I knew nothing about GMP. I knew nothing about pharma.GxP came to me unexpectantly! Given the company was making therapeutic claims on their labels, our national regulatory agency stepped in requesting that products undergo registration and the site be licensed as a manufacturing and packaging facility. This was all a shock to everyone, as no one knew where to start, or where to go, or what was involved.As the old saying goes, `throw them in the deep end and you are left with 2 options: Sink or swim...!' I had no choice but to swim. Now I was on my way to learning pharma--start to end!Stability trials, cleaning validations, documentation, deviations, OOS's, CAPA's, PQR's etc. I was treading water--only just--then I began to swim! I was learning!31 years later, and I'm still learning every day. Having gained experience in sterile and non-sterile products consisting of oral solid dose preparations, SIGNIFICANCE OF GMPS IN PHARMACEUTICAL MANUFACTURINGRobert Zanon
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