TECH OUTLOOK 8SEPTEMBER 2023IN MY OPINIONHaving 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, vaccines, antivenoms, blood products, antibiotics, hormones, chemo-therapy drugs etc. and having worked overseas in clinical trials for several years, I have gained the knowledge and insight into GxP's and the expected industry standards from those compared from yesteryear. Furthermore, working with regulatory agencies such as the FDA (US), KFDA, EMA, TGA has provided me with an insight into the increasing demands on pharma industries. As with many things, one area which I have seen evolve over the years is `cleaning validations' and the regulatory expectations to assure consumer safety and product efficacy. Over the years, I came to see cleaning becoming closely associated with `process validation.' In the early 90s, regulatory agencies began to view cleaning as a process that needed to be validated. At the same time, several safety incidents involving cross contamination solidified this viewpoint. Therefore, many companies set about validating their existing cleaning procedures without questioning whether the procedures utilised were the most effective or optimal, or even if they were using the appropriate cleaning agents and detergents. Traditionally, (back in my early days), cleaning validations incorporated a pre-approved protocol, with predetermined By implementing a truly science-based approach, such as the use of appropriate risk assessments, a streamlined cleaning program may be readily developed that ensures patient safety and product quality while lightening the regulatory burden on industriesSIGNIFICANCE OF GMPS IN PHARMACEUTICAL MANUFACTURINGBy Robert Zanon, General Manager, Quality, Probiotec [ASX: PBP]
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