By Paul Thomas, Managing EditorNow that pharmaceutical manufacturers are pressing ahead with process analytical technology implementations and strategies, a new question arises: who is going to staff these initiatives? Which workers will have the skills and flexibility to carry through with their companies PAT programs?Its a real concern, says Jon Tomson, who is heading up ISPEs Pharmaceutical Manufacturing Professional of the Future Initiative, which is working with industry, FDA and academia to identify the knowledge areas and skill sets that will be critical to the industrys future. One of the things the group is currently doing is performing a sort of gap analysis of current and future workforce needs, Tomson says, and so far its obvious that there will be a dearth of experienced workers who understand PAT and can perform the analytical and statistical task that will be required as industry upgrades and reorients its processes.Industry needs to advise academia on the shortcomings of graduates coming out of the universities, adds Jerry Roth, P.E., ISPEs director of professional certification. PAT is about innovation and bringing the pharmaceutical industry out of the 1920s and into the 21st century.In turn, academia will need to ensure that young students and professionals who are retraining get access to proper science-based education, say Tomson and Roth. That means putting the principles of PAT into academic curricula and training seminars everywhere.DuQuesne Universitys School of Pharmacy (Pittsburgh) has taken this to heart. Jim Drennen, Ph.D., division head of pharmaceutical sciences in the pharmacy school, has been integral to the ISPE initiative. We have an extremely talented pharmaceutical workforce, Drennen says. But we dont have the right people with the right backgrounds to allow advances in PAT and process control. The process analytical technology (PAT) movement is moving faster than companies workforces can handle, says Drennen, who predicts that drug manufacturers will experience a lag time sometimes two or three years between drafting their PAT programs and assembling the teams of individuals needed to carry them forth. DuQuesne is aggressively pursuing a more science- and risk-based curriculum that parallels FDAs PAT initiative. A critical element to DuQuesnes classes is hands-on training in areas such as PAT laboratory techniques and statistical process control. The training is being offered not just to students, but to pharmaceutical industry professionals and even FDAs inspectors and PAT corps.In courses, students can:
- monitor and contol a lab-scale version of the tray drying process using themal data and NIR sensors
- monitor and control a lab-scale bin blender with an on-board NIR sensor.