Meanwhile, U.S. inspections continue to be challenging, observers say, in part because the agency’s priorities and definition of cGMP continue to evolve.
In previous years, quality assurance managers at pharma manufacturing plants knew more or less what to expect from an inspection. The inspections would take place every 24 months or so, and inspectors and QA people more or less spoke the same language. cGMP standards may have varied a bit between inspectors and companies, but in most cases industry and the FDA were on the same page.
Of late, however, a gap has opened between the FDA inspection teams and the QA management teams at pharma plants, says Edward John Allera, an attorney who’s chairman of the FDA section of Buchanan Ingersoll & Rooney PC’s DC office.
“What we’re seeing more and more of is inspectors saying what’s cGMP rather than following the evolving standards of the industry,” Allera says.
According to Allera, there’s a “new aggressiveness and competitiveness in the field”—“who can be the toughest on, say, parenterals,” he says. Inspectors are even getting tougher about basic inspection requirements—for example, requiring photographs of the plants they inspect and demanding CDs containing all of the documents they want to review.
Allera believes the FDA has gotten more aggressive for a number of reasons, but one critical one is the “virtualization of the industry,” he says. “You’ll have your API from abroad, contract lab work somewhere else, someone else as your third party logistics provider, contract CROs and so forth—and the FDA is concerned about this.”
Not only has the FDA been showing up more often—and demanding more—the teams it sends are often less experienced than current generations of pharma managers are accustomed to working with.
According to one senior QA manager with a large biotech firm (who asked not to be named), many of the inspectors showing up at his plant are new to the job and years away from having learned their craft. Not only does that force the manager to answer lots of questions that might never have come up before, it also slows down the process of getting the inspection done, he notes. “If they’re going to come for a couple of days several times, and they’re not efficient, it can be a major distraction for us,” the manager said.
Besides, as one ex-FDA-er notes, avoiding the slip-ups that lead to 483s makes financial sense. While it may seem smart to shave down QA costs, “making a lot of products that are recalled or rejected can cost a lot more than getting it right the first time,” notes the official.