FROM GOOD INTENTIONS TO BEST PRACTICES
The big spending to gold-plate quality, the complying with non-existent regulations, and the care taken not to stir up the
FDA are all intended to improve compliance. Ironically, those good intentions often produce the opposite result. And they're
Instead of operating out of good intentions, it's far better to strive for best practices. It begins with a clear-eyed assessment
of end-to-end processes guided by the simple Lean principle that waste is bad and should be eliminated now. The assessment
may include step-mapping and in-depth interviews with personnel about what they do. And there should always be the question:
why? Why do you do it that way? And if they say that the FDA requires it, then the question is "are you sure?" The next step
is to check agency guidance and review correspondence with the agency, ideally in a searchable database.
In an assessment of two biotech plants operated by a leading global pharmaceutical company, we found hundreds of opportunities
for cost savings. In isolation, many of the wasteful and unnecessary activities appeared to be relatively small matters, but
in the aggregate they added up to millions of dollars in waste and significant amounts of time spent on compliance problems.
Using Lean techniques to identify opportunities and eliminate wasteful and unnecessary activities, the plants were able both
to improve compliance and lower costs. For example, the chances for noncompliance, whether caused by personnel or equipment,
were greatly reduced by:
- eliminating process steps such as the 15-L inoculation in fermentation and the drying step in formulation to simplify the
- eliminating unnecessary testing steps such as filters testing in media prep that caused the filter to fail
- increasing the short validated dirty hold time
- increasing batch size in purification reduced the overall number of batches run per year
- reducing the frequency of process steps such as column packing in purification from every 50 to 100 runs
- reviewing the environmental testing frequency to determine permissible reduction and elimination of tests, resulting in less
- evaluating the feasibility of setting frequency by location, based off trended historical data
- evaluating what was really necessary for non-aseptic class C
- automating laboratory air results to eliminate manual or paper-intensive processing.
All of these improvements were based on genuine FDA requirements, not phantom regulations, folklore, or merely good intentions.
In effect, compliance was treated as a "pull" system, analogous to the pull system in heavy manufacturing, where the amount
of material and the timing of activities are determined by what is necessary—and only what is necessary —as the product moves
through the factory. In this case, however, pull is exerted by genuine, documented requirements, which determine what compliance
activities are really necessary as the product is produced. By contrast, a "push" system heaps unnecessary compliance activities
on products and processes in the mistaken belief that more is better.
In a pull system, less is more—producing dramatic improvements in return on investment, quality, efficiency, and cost. And
because of the regulatory complexities of biotech drugs and the unnecessary activities they often generate, the number of
opportunities for improvement is far greater than with small-molecule drugs. All that is required is a determination to take
a hard look at business and production processes with fresh eyes, free of the conventional wisdom that efficiency puts compliance
at risk. Then the operations executive under enormous cost pressure and the head of quality concerned about the next inspection
can link arms and confidently declare that they want to eliminate waste because it saves money and improves compliance.
Chris S. Driscoll is principal at Tunnell Consulting, King of Prussia, PA, 215.422.2044, email@example.com