Standardization and Certification Challenges for Biopharmaceutical Plants

C O M P U T E R 0 0 1 8 9 1 6 2 / 1 7 / $ 3 3 . 0 0 © 2 0 1 7 I E E E P U B L I S H E D B Y T H E I E E E C O M P U T E R S O C I E T Y S E P T E M B E R 2 0 1 7 83 Bioprocessing—a technique that produces biological material, such as genetically engineered microbial strains and commercially useful chemicals—is big business in the US and growing quickly around the world. An increasing number of pharmaceuticals are now manufactured using bioprocessing techniques. Quality control of these products is a huge issue. Bioprocessing (and the pharmaceutical industry in general) is highly regulated. The groups that develop guidelines, standards, certifications, validations, and so on aim to ensure extremely high quality levels from the manufacturing plants’ pipes, tanks, and valves all the way through the finished product, with a focus on cleanability, sterility, and reproducibility. However, in the past 10 or so years, the industry has been pushing for increased plant efficiency and manufacturing globalization, and is now focusing on plant automation. The groups involved in standardization, certification, and validation have been working hard to keep up with the industry’s needs and stay in sync. A brief discussion of these organizations with some history gives additional perspective on the current state of biopharmaceutical plant standards and regulation. Standardization and Certification Challenges for Biopharmaceutical Plants