In one extreme case, an FDA inspection concluded that Zorro Technology didn’t have written quality control procedures at all, that drug ingredients weren’t identified in terms of their status, and that batch records identifying the weight of compound quantities to be added weren’t present.
Of late, inspectors are getting tougher about documentation requirements. In some cases, inspectors actually sit down in front of your computer and search through your documentation themselves. Not only that, in a relatively new twist, they’re requiring photographs of the plants they inspect and demanding CDs containing all of the documents they want to review.
Once they’ve done their doc review, get ready. When the inspectors ask to see specific pieces of documentation, you’d better be ready to turn them over pronto.
According to one expert, one company was recently cited with a 483 simply because they didn’t turn over documents quickly enough—and the inspector had demanded quite a lot of them.
The bottom line: Make sure you have qualified people in control of document flow.
Slip-ups here can lead not only to 483s, but also a tougher investigation overall.
“If an investigator asks for documents and the firm waffles, the investigators are going to get upset and may even wonder if the firm is going to fake them later,” according to a consultant who works with biopharma firms.
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