Therapeutic Dose: The Perfect Storm

(Financial pressures + regulatory changes) = new manufacturing paradigm (- breadth of experience + narrow focus) = problems achieving Quality by Design.

By Emil Ciurczak, Contributing Editor

I was perusing the “Positions Available” section of C&E News (just looking, I enjoy not showing up five days a week at the same place) and, as usual, grumbling about the descriptions. One that always gets me is the desire to place an organic chemist in charge of an Analytical department. I often see someone in charge of something and comment that I could easily do the job, but I could never get the job. There is a tendency to advertise for a person with the same qualifications as the individual currently holding that position, not for someone who could do the job better. No, that might prompt a “you’re overqualified for this position” response from the HR department.

Think about that statement for a second. Were you to need an operation, would you tell a doctor, “No, you’ve performed too many heart transplants — you’re overqualified”? I doubt it; but we seem to think chemists, pharmacists and process engineers become worthless when they have experience. Perhaps the quote should be, “No. I think we can find someone to work for less money.”

That got me to thinking about our narrow-minded industry. In the early 1980s, while I was at Sandoz, the Colors and Chemicals division moved to South Carolina, leaving a number of employees to seek other positions. Since internal hiring was our practice, I suggested that a woman I knew to be a super chemist submit an application for our section (in the QC department). After several weeks, her application had not appeared. When I inquired as to its status, I was told by HR that she didn’t have the buzzwords, “USP and routine tests” on her resume, so they ignored it.

She eventually got the job. She and I worked together and presented several NIR papers, but not because of any help from the HR people. The job’s primary responsibility was method development, and those words don’t appear on any QC job description! She was perfect for the job, but couldn’t get it (until additional leverage was applied).

Makes me wonder how we expect QbD and PAT to succeed. Since they are new, there are very few job descriptions with those “buzzwords” included. Even more scarce are resumes with QbD or PAT as accomplishments or goals. I fear that will management and HR fall back on “tried (or is that “tired”?) and true” job descriptions and position-filling procedures. One problem with filling a position with someone who has done nothing but that job is that there is no cross-pollination. Since the paradigm has changed with QbD, doing the job the same way with the same type of personnel fits the definition of insanity.

I fondly recall the cross-training I received at Ciba in 1970: one week making tablets, one week in sterile products, one week in clinical packaging, etc. When I started my “real” job I had an understanding of where my position fit into the overall scheme of things. While I was tasked with measuring package/product interactions, I had sampled a full-sized V-blender, made my own chewable vitamin C tablets, made pre-formulation compatibility samples for stability testing, and worked with the consumer products (like Binaca breath spray). Do companies take the time to do this cross-training anymore? Whence cometh then QbD personnel, prithee?

Once more, with my firm grasp of the painfully obvious, I would like to make a simple suggestion. Would it be all that hard to do some cross-pollination between departments? On a larger scale, the Swiss giants (at the time still independent) Ciba, Sandoz, etc. had continuous exchange programs for U.S. and Swiss scientists so that they could familiarize themselves with the other groups within the company. It was much easier to work from another continent when you knew the faces and job skills of your overseas colleagues.

Now, extrapolate this to QbD; wouldn’t it behoove a physical pharmacist, setting parameters for new APIs, to actually work on a compression line and see the potential problems? How about pre-formulation people being concerned with real stability issues?

One immediate benefit of the cross-training program at Ciba was when a formulator (Glenn van Buskirk) was reformulating a chewable Ritalin tablet. Before he proceeded to stability trials, he asked if the new ingredients might interfere with the current assay. In fact, the red dye (they were cherry-flavored, if I recall) interfered with the colorimetric assay, which developed a red color for spectrometric quantification. His awareness of another department’s potential dilemma allowed Analytical R&D to develop a new assay before it was needed.

How much better would a QbD program be run if all the members of the committee had a smattering of knowledge of each step in the production of a solid dosage form? Unless we start to work as an organic unit, we may as well break out the slickers and life vests — it’s gonna get ugly before the weather breaks.

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