Reducing Variability in Small Batch Drug Kitting

What happens when a large pharmaceutical packaging company that usually prepares hundreds of thousands of doses of mature drug products for shipments to commercial distributors needs to prepare a small batch run of product – say, 500 or 1000 doses for a clinical trial? Do they simply borrow one of their high-speed lines for an hour or two? Probably not. There are major differences between the highly automated, high volume approaches versus those employed by short run, manually based operations. The issue then is: how does one achieve that same level of quality at the endpoint for a small batch drug kitting process without the automation used in the high volume lines?