One topic most people seem to tap-dance around when discussing PAT is the number of bodies that will either be added or deleted. Of course, this is (and should be) an important subject for management to consider.
While working with a NIR instrument company, I remember some difficulties in installing the on-line systems. Not technical problems, mind you, installation problems. One installed unit was accidentally hosed with water while the floor was being cleaned; another was accidentally struck by a fork-lift. Several fiber optic cables were used for steps by personnel to reach higher shelves. It seems that these manufacturing workers were not briefed as to why the instruments were being installed. They were afraid that there was to be a headcount reduction, and so acted accordingly to the threat. Education would have prevented these problems.
Now, I have been attending PittCon since 1971 and have never felt the urge to ask a question or comment on a paper until last year (2005, Orlando, Fla.). A speaker from a large pharmaceutical company suggested that the personnel from Quality Control could be retrained for other jobs; after PAT was up and running, QC would shrink drastically! NOW I was motivated to comment! [For some strange reason, people cringe when I raise my hand at a meeting.] I asked why these qualified people would lose their positions in PAT. For some strange reason, he seemed to believe that PAT was instantaneous or a one-time event. I quickly pointed out that he may have the headcount moving in the wrong direction; PAT will likely add to QC headcount. (Apparently, the process workers werent the only ones who were mistaken.)
Now, exactly why will there be more bodies because of PAT and why have we been avoiding admitting the fact? Well, the why the bodies will increase is simpler to address. The answer breaks down into three categories:
- The process work will need to continue (for the foreseeable future) as it is now, demanding the same number of analytical tests be run. But, the newly installed monitoring equipment will need technical help: installation, engineering, maintenance, and so forth. The current workers will not be trained (immediately), so more bodies will need to be added to specify, buy, install, and run the hardware.
- The new technologies will need to be calibrated (both daily and for new methodologies). Since newer technologies (to Pharma, anything except pH and HPLC are new) such as NIR, Thermal Effusivity, Acoustics, and LIF need wet chemical calibrations, many, many more assays will be performed in QC in order to calibrate them.
- All the PAT data will need to be gathered, collated, store, retrieved and made available for reports. This will increase the number (and educational level) of IT personnel, often by a large amount. The integration of the various technologies will be a full-time job for more than one person. The mountain of data generated by PAT will need to be well-handled for the process to have any meaningful impact on product improvement.
For instance, if a tablet analysis is desired and it will be performed (say, by NIR) on thousands of tablets per run, a robust calibration must be made. To do this, thousands of tablets (to assure variability in chemical and physical differences) will have to be run both by NIR and HPLC. Since the current release methods and stability samples will need to be run simultaneously, there will be an influx of QC chemists to accommodate all these additional assays. (And they wont go away as long as PAT methods are being investigated for each additional product.)
The why we tiptoe around it is more subtle and directly related to economics. Since the managers who need to be convinced about PAT are not (despite what they profess) intimately familiar with the day-to-day workings of production. A given (high level) manager will not be concerned with what each worker does every day. To sell them PAT, we (correctly) explain that PAT will help with process understanding, make the product better, reduce FDA surveillance (risk management), make better use of equipment, and increase the profit margin of the product. In reality, many managers simply hear, blah, blah, blah, blah and increase the profit margin."
With profit firmly planted in the minds of management, mentioning a headcount increase could be a show-stopper! It seems, at first blush, that cost savings and simultaneous personnel increases are counterintuitive. (Fortunately, the Egyptians knew better and didnt try to build the pyramids with 25 workers.) Since most upper level managers are not conversant with the technical issues, the increase in headcount tends to stand out. It is incumbent upon the people selling PAT not to gloss over the short-term increase in costs, both in hardware and personnel, when explaining the overall program.
Upper management did not get to be upper management by being stupid; trying to sugar-coat the costs and timeframe of PAT will cause many problems later. If realistic deliverables are not presented, unrealistic deadlines will be set and missed. PAT is going to save big bucks; is going to make products better; is going to work. But, like the space program, we will not get to the moon in three weeks. It took nearly a decade for Apollo 11 to land after the commitment to do so was made. PAT will not cost as much or take as long, but in the long run, may well make the lives of more people better than the space program ever did.
About the Author
Emil W. Ciurczak has more than 35 years experience in pharmaceutical manufacturing, analytical R&D, and regulatory compliance. He was a member of the validation subcommittee for the Pharmaceutical Advisory Committee for FDA and a consultant to the FDA.
He is the co-author or co-editor for several texts, including Handbook of Near-Infrared Analysis (1st & 2nd ed) and Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy. He is also Contributing Editor to Spectroscopy and is on the Editorial Boards for American Pharmaceutical Review, JPAT and Journal of NIRS.
Ciurczak holds a B.A. and M.S in Chemistry from Rutgers University and an M.S. in Chemistry from Seton Hall University. He holds patents for both instruments and software relating to spectroscopic analyses and has over 60 publications.