It has been almost 3 years since I received the first phone call from a company requesting a 'PAT-trained' student, and industrial
interest and investment in PAT is continuing to grow. In my recent visits to industry, human resources (HR) personnel have
been keen to learn where future PAT personnel will come from, to develop job descriptions for these positions and to learn
which skills the new hires will have.
This article discusses four facets of PAT and HR:
- The skills required of the new hires.
- How to involve current personnel in PAT initiatives.
- How PAT, Quality by Design (QbD) and the new Quality Systems Initiative can enhance pharmaceutical productivity.
- The need for continuous learning.
Hiring a PAT-trained student
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Before hiring a PAT-trained student, companies should first assess the capabilities of the current personnel involved in the
PAT effort. PAT hires should complement the skills of those already on board to bond as a good PAT team. Without the support
of the team, he/she will be ineffective. PAT requires establishing a work plan, which should be a goal for an entire company
rather than a single operating unit. Furthermore, companies should discuss their PAT plans with the FDA as usually only one
person at a manufacturing site is authorized to contact the FDA.1The PAT hire also needs to have a wide range of interests that encompass the different aspects related to pharmaceutical manufacturing.
For example, the PAT hire may have a strong background in chemometrics, but will also require a desire to learn about pharmaceutics
and concepts of interest to industrial engineers (efficiency, down time and scheduling). Additionally, he/she will need to
work with data management personnel to determine how data should be stored and evaluated. While the PAT team starts a new
project, there will also be quality control (QC) personnel trying to implement risk management throughout the company. The
PAT hire does not have to be an expert in risk management, but should be interested in understanding its relationship with
PAT.
PAT is about understanding pharmaceutical processes. Therefore, interest in pharmaceutics and visualizing interactions between
the different components in formulations are essential; for example, the new PAT hire should not develop a method to determine
blend homogeneity without first discussing mixing with industrial pharmacists and pharmaceutical engineers. The PAT hire must
be able to organize efforts to extract relevant data from a pharmaceutical process.
A PAT hire must be able to obtain and interpret data relevant to the manufacturing process. Many situations require an initial
observation of the data, a cursory evaluation or simple exploratory analysis before initiating additional efforts. HR personnel
are hearing the new word 'chemometrics', which is linked with data, equations and a possible recruiting difficulty as chemometrics
courses are relatively rare. Chemometrics is the chemical discipline that uses mathematics, statistics and formal logic to:
- Design or select optimal performance experimental procedures.
- Provide maximum relevant chemical information by analysing chemical data.
- Obtain knowledge about chemical systems.2
Figure 1
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The ability to work with data is intimately related to attention to detail; for example, in near-infrared spectroscopy and
many of the spectroscopic methods used in PAT, subtle differences in spectra can be very important. An unskilled analyst might
look at the spectrum shown in Figure 1 and not see any difference, but the trained analyst will find differences such as those
observed between 8866–8666 cm–1 Skilled practitioners would recognize that these near-infrared spectral differences are important in developing a method
to determine the drug concentration of tablets.
Current personnel
The PAT team should include a veteran member who is thoroughly familiar with the manufacturing processes and challenges. This
person should be capable of outlining the critical problems in manufacturing processes. They could provide feedback such as:
"The real problem is that this product constantly sticks to the punches; we can monitor and control previous steps, but if
the product continues to stick we still have the same problems and bottleneck." The veteran must provide feedback on the daily
problems that affect manufacturing and possess the process knowledge needed to improve it. Many personnel frown upon change
as, for them, a change in a process means that it was not adequately validated. The veteran should be thoroughly familiar
with company procedures and capable of convincing personnel of the importance of the PAT initiative so that they do not hinder
its progress.3
Pharmaceutical companies often have much more in-house expertise to support PAT initiatives than they realize, as current
personnel may include scientists who worked with chemometrics or made real-time measurements as graduate students, but have
now focused on other areas such as separations, after joining the industrial environment.
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