cGMP Quality Agreement Tip – Remember Definitions!
March 28, 2013 A cGMP quality agreement is a written contract that defines all of the quality parameters for a project and which of the parties is to be held accountable for each parameter. How detailed the quality agreement template is will depend upon which stage the drug or device product is in. Some of […]
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No Quality Agreement? You’re Asking for an FDA Warning Letter
7 Tips to Hire a Top GMP Consultant Dirty Business – Is GSK Pressure on FDA Influencing Hospira 483 Failures? March 28, 2013 FDA often sends warning letters to drug and device companies for not having a drug quality agreement with a contract manufacturing organization (CMO). Such a warning letter typically says something along the […]
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7 Tips to Hire a Top GMP Consultant
Is GSK Pressure on FDA Exacerbating Hospira 483 Mess? More Exclusive Expertbriefings News Upcoming Expertbriefings March 28, 2013 Due to all the layoffs in the pharma industry in recent years, we have seen a flood of new consultants in the pharmaceutical field. We’ve talked to quite a few experienced hands in the industry and this […]
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PDF Requirements a Critical Aspect of FDA eCopy
March 27, 2013 If you do not want your eCopy submission to be put on hold, you need to be really sure that you understand the FDA’s PDF requirements. And there are signs that many in industry are struggling with the stringent PDF requirements of eCopy. No matter if you select a volume or non-volume […]
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More FDA Inspection Tips (And One Unforgettable Quote from the FDA Compliance Director)
March 26, 2013 After our recent very informative Webinar on FDA inspection tips, we asked some of our readers what the most important things are to avoid FDA 483s. Here are some of our favorite responses: Pre-Inspection It is important to practice inspection readiness on a daily basis. Run a mock audit often and review […]
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Tips to Perform Your Next Laboratory Quality Audit
March 26, 2013 It is always strongly advised that a laboratory conduct its very own internal quality audit every few months to make sure that test analyses always provide reliable results. By doing an internal audit, you also will provide your lab with detailed knowledge of how well it follows its own quality guidelines, and […]
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PDF Problems Reported With FDA’s New eCopy Rule
March 24, 2013 In the last 10 days, we have been reporting on some of the problems and confusion surrounding the new eCopy program by FDA. You can read our other reports on eCopy here, here and here. In eCopy, the agency seems to have a belief that PDFs are an open format that one […]
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The Death of Paper – FDA eCopy
March 24, 2013 The date Dec. 30, 2012 was a big one for regulatory. This was the last day that you could submit a major application just on paper. In its place is the new eCopy system just finalized by FDA in January. According to what we have been hearing from industry, many people are […]
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More Tips to Survive Your FDA Clinical Inspection
March 22, 2013 We sat down last week with Dennis Moore, the president of AUK Technical Services. Dennis was an FDA investigator for more than 15 years and has some interesting perspectives on FDA clinical inspections, to say the least! He also provided some great tips on regular FDA inspections. Make sure that you always […]
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FDA Recall Strategy Tips
March 25, 2013 We recently had the opportunity to chat with Rita Hoffman, who currently is the managing partner of RHoffman, Inc. She has more than 35 years of FDA experience in drugs, devices and veterinary products. Until 2010, she was the recall branch chief for CDRH. She gave us some useful FDA recall tips […]
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