The QA Pharm

Top 10 Warning Letter Observations about the Pharma Quality Unit

The responsibilities of the Pharmaceutical Quality Unit are defined in the CGMPs and practices clarified in guidance documents. (See The QA Pharm, August 7, 2011.)  Just as it is with any legal matter, case histories help us understand how the law is applied in specific situations. That’s the reason it is a good practice to …

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Is flu vaccine supply in jeopardy from Australia’s CSL Biotherapies?

The answer depends on who you listen to: the FDA or the EVP at CSL Biotherapies.  According to the FDA Warning Letter issued on June 15, 2011, the issues are among the most significant as any we have seen in recent years following the company withdrawal of the vaccine after reports of seizures with use …

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FDA: For Corrective Action Plans, Where are the Resources?

Imagine the stream of firms that venture in to their respective FDA District offices to give presentations on their Warning Letter response and to offer their assurance that they truly “get it”.  You can be sure that theses firms had several “dress rehearsals” to hone their material before stepping into what they perceive to be …

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Business Process vs. Compliance Process: What’s the Difference?

Having recently flitted about on several of our finest air carriers across several continents, I have thought about how certain practices by the flight attendants are predictably consistent, and others vary.  For example, we’re always told to turn off our electronic devices at the point when the airplane doors are closed.  However, when it is …

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