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 …
Top 10 Warning Letter Observations about the Pharma Quality Unit Read More »
Responses to FDA 483’s and Warning Letters are usually fully of commitments. They involve “what” will be done to correct compliance problems, and “when” it will be done. FDA has even started to ask “how” they will be done, meaning—Do you have the resources to do the work?
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 …
Is flu vaccine supply in jeopardy from Australia’s CSL Biotherapies? Read More »
Once upon a time, I asked this question of a senior management group at an off-site “strategy” meeting. You know—one of those meetings where a working breakfast was followed by a day of golf, and I was the one doing the working.
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 …
FDA: For Corrective Action Plans, Where are the Resources? Read More »
I am convinced that there is an element in some pharmaceutical companies that enjoys the adrenaline rush of a crisis. These are the people who descend upon problems and save the day through sheer grit and determination. They work late to pull the proverbial baby out of the fire. They are known as having a …
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 …
Business Process vs. Compliance Process: What’s the Difference? Read More »
It must be that time again when conference planners rack their brains on how to bolster dwindling attendance, because several have contacted me through this blog to ask my opinion on major trends in the pharmaceutical industry.
The Warning Letter to Ningbo Smart Pharmaceutical Company (dated 3/3011) revealed that they had reported conformance to specifications on Certificates of Analysis when in fact—no testing was done. (Among other issues.)
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