From the FDA, a missive to the management of Trifarma S.p.A.:
Your firm did not retain complete raw data from testing performed to ensure the quality of your APIs. Specifically, your firm deleted all electronic raw data supporting your high performance liquid chromatography (HPLC) testing of all API products released to the U.S. market. In addition, your firm failed to retain basic chromatographic information such as injection sequence, instrument method or integration method for the tests. Your firm’s lack of data control causes us to question the reliability of your data.Oh, those old files? We don't need them! (You really wonder what happened to them -- freak backup accident?)
In addition, your laboratory management was unaware of, and therefore did not follow, the written procedure detailing the review of analytical data. Furthermore, your management confirmed that the review of analytical data did not include evaluating the system suitability parameters to ensure proper column performance.
I know where they went - into the hard-drive shredder with the IRS hard drives from Learner's office! Amazing how data can just disappear, isn't it?
ReplyDeleteSeriously, let's see how far "The Dog Ate My Data" excuse goes with the regulators. I'm thinking not far.
From the "The Dog Ate My Lab Reports" department, no doubt.
ReplyDeleteI don't understand why the FDA doesn't immediately shutdown all imports of their products. And look really hard at any business incorporating these APIs into meds sold in this country.
Sounds like that's a possible step:
DeleteUntil all corrections have been completed and FDA has confirmed corrections of the violations and your firm’s compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as an API manufacturer. In addition, your failure to correct these violations may result in FDA refusing admission of articles manufactured at Trifarma S.p.A., in Rozzano, Italy into the United States under Section 801(a)(3) of the Act, 21 U.S.C. 381(a)(3). The articles may be subject to refusal of admission pursuant to Section 801(a)(3) of the Act, 21 U.S.C. 381(a)(3), in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of Section 501(a)(2)(B) of the Act, 21 U.S.C. 351(a)(2)(B).
Shouldn't important data be mirrored somewhere? If it's important and sensitive, then shouldn't it be compartmented but mirrored? (Leaving one copy is not equal to secure). If you only have one copy and it conveniently goes away when someone looks, well, someone is likely to think that either you shouldn't have had it or you didn't want them to see it (because it says you were doing or not doing things you shouldn't or should have been doing) rather than you're incompetent (because the level of incompetence is so high as to strain credibility).
ReplyDeleteEven before that though, isn't it a critical problem that they didn't know how to review their own analytical data, or didn't know whether their methods worked for what they made and were checking? These seem like instant showstopper errors, because their analytical techniques could be completely useless, and you may not know what they have based on their data. They also seem like bad analytical chemistry errors - apparently actually checking if your employees know what they're doing was optional.
Yeah, I don't really get it, but FDA/cGMP is pretty strict about these things.
Delete