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LIFESCIENCELEADER.COM JANUARY 2015 46 TRAINING BIOPHARMA MANUFACTURING Today, GMP-compliant manufacturing of biopharmaceutical drugs and vaccines is still only partially automated and not at the level of other manufacturing industries. Critical process steps such as sampling, sterile connection, or column packing are carried out manually by operators, which can negatively impact process reproducibility, product quality, and — in the worst case — even patient safety. A L A I N P R A L O N G Overlooking GMP Biopharm Education/Training Can Cost You – Big Time By A. Pralong OVERLOOKING GMP BIOPHARM EDUCATION/TRAINING CAN COST YOU – BIG TIME o mitigate risk and achieve compliance, extensive qual- ity management systems (QMSs), including personnel education and training, have been built based on SOPs. Review of recent FDA enforcement actions (e.g., warning letters issued on 7/18/13 to Wockhardt Limited and on 8/9/11 to Beckman Coulter, Inc.) raises serious doubts about the effi- cacy of the current approach toward quality management and associated knowledge transfer methodologies. The FDA's findings indicate that personnel education/training, a lack of written procedures, and not following written procedures were among the top reasons priming enforcement actions. Settlement of warning letters normally comes at very high cost. For example, Wockhardt executives mentioned that the cost of a warning letter could reach $100 million. Correction and control of this major quality risk exposure requires biopharmaceutical companies to adopt alternative approaches for inte- gration of operator education and on- the-job training (OJT) with comprehen- sive quality management systems. THE BIOPHARM INDUSTRY IS BEHIND Greek philosopher Socrates spent signif- icant time developing an education and training method for his students based on stimulation of the individual's power of reasoning. Since then, various other researchers (e.g., Ivan Pavlov, Hermann Ebbinghaus, Edward Thorndike) have strived to improve upon the process of efficient knowledge transfer. Interestingly, though, the biopharma- ceutical industry has rarely adopted the concepts developed by these researchers and philosophers. Instead, highly edu- cated process engineers and scientists have written comprehensive SOPs and batch records in an attempt to capture in wording all instructions and handling necessary for the execution of practical activities. Then, on the shop floor, operators with less scientific, GMP, and engineering understanding face the challenge of back-translating these instructions from words into practical execution of activities. This situation is prone to errors. Person-to-person understanding or interpretation of wording can vary and lead to issues with compliance since reproducibility is not ascertained. This situation is further aggravated by the widespread practice of operators not routinely consulting SOPs when executing tasks. In the most modern stainless-steel- based biopharmaceutical manufacturing facilities, some of these problems have been addressed using process automation where applicable. Facilities are operated with sophisticated electronic building management and batch record systems (BMS and e-Batch Record) that improve process control and reproducibility by preventing operator errors. These complex systems come, however, at sig- nificant cost ($400 million+) and are most efficient in large-scale routine manufacturing. Interestingly, knowledge transfer to personnel is still based on SOPs, and a further negative consequence of this automation approach is that operators may lose track of process rationales and detailed understanding of executed activities. This exposes bio- pharmaceutical companies to significant risk of GMP noncompliance and process inconsistencies as a consequence of a "push-the-button" approach. During the last 20 years, increasing T