We see here yet another example, unfortunately, of a drug company potentially falsifying data to support pharma manufacturing. In this warning letter, the FDA noted that the data falsification was admitted. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm503699.html
We have to remember that cGMP standards are always changing and that change is towards heightened (not lessened) compliance standards. But changing standards is not enough.
It is the culture of the company that must also change. Peoples' attitudes towards compliance need to change. It is no longer acceptable for attitudes to be grounded in the past; that which was compliant in the past may not be compliant today. The culture of compliance needs to be cultivated from the top management down to the lowest person. The company that continues to follow the "it's not wrong until you get caught" is doomed to fail.
I wrote about the culture of compliance and the need for employee training by identifying some key areas of cGMP improvement. See here: http://www.lexology.com/library/detail.aspx?g=ee3b1f31-4b67-48dc-aa34-82314f37c0f9
In my practice, I am seeing more enforcement action being taken especially heavier enforcement actions on previously considered minor areas. When I give compliance training, the level of anguish on the audience is noticeable when I ask questions about escalation of GMP violations, threats of retaliation for reporting violations, and perhaps even naming senior management as the culprit.
And when it comes to falsifying data, should the FDA really give any company a break? Or should the FDA bring the full bore of enforcement down upon a company. Any company that condones falsification should ask if it is worth it?
Let's take a look at some quick effects of a GMP enforcement action:
- bad publicity, bad reputation
- potential shut down or import alert
- your failure to supply could mean new opportunities for your
competitor- potential breach of contract for failure to
supply
- possible civil and criminal penalties
- possible lawsuits by the public who may be injured
In short, too many bad things happen.
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