In another significant slip, inspectors found that Zorro Technology had not given employees any training in cGMPs (or at least couldn’t prove that they had).
Today is our last strategy for avoiding cGMP 483s – make sure QA employees are adequately educated, trained and supervised. Again, this may seem obvious, but in a cutthroat environment where R&D gets the money and QA the budget cuts, it doesn’t always happen.
Knowing this, the FDA has begun to question credentials of QA workers in ways it hasn’t done before. To be fair, if things aren’t going right on the plant floor, it could be due to turnover, budget cuts or a lack of management commitment to quality.
But when inspectors come calling, they’re going to start by making sure QA workers know their jobs.
In many cases, training suffers because management has a strict formula for how to staff QA department, such as “revenue per X employees,” but that can lead to problems. “That’s the MBA mindset, but it doesn’t hold up in heavily regulated industries,” an ex-compliance official says.
Training alone isn’t good enough, though. Make sure that you document any training you do, in fine detail. Some firms have actually provided good training, but haven’t documented it well enough. That just isn’t good enough, an ex-inspector says. “The FDA mantra is that it’s not on paper, it didn’t happen.”
Other 483 Resources
- The largest online 483s store (with thousands of FDA 483s in PDF format) Search by inspector or company>>. Readers of this blog receive 20% off – enter “fdazillablog” at checkout.
- The only searchable listing of 483s
- FDAzilla Inspector Rank – how often does your inspector issue 483s?
- FDA 483 article archives