Saturday, August 28, 2010

Quality Control Unit: Invertebrates Need Not Apply

The Quality Control Unit (QCU) is the only pharmaceutical function that has a job description codified in the CGMP regulations.

Don’t you find this remarkable?

In fact, an entire section is devoted to describing the responsibility of the QCU and how it is to operate within the organization—namely independently.

Concerns about an independently operating QCU were raised when CGMPs were first proposed in 1978, and some companies have struggled with “independence” ever since. The Commissioner responded to those concerns in the Preamble to the CGMPs1, which we often consult for insight into the intent of the regulation.

Basically, “independent” means…well, “independent.” The regulatory authority and responsibility of the QCU is not to be subordinate to any other unit where there is the potential for a conflict of interest.

Operating independently does not mean being insular, or elitist. It does mean, however, to have the ability to make objective, scientific, data-driven decisions and being sufficiently articulate to make the case for doing the right thing—then doing it.

However, there appears to be a big gap between the requirement and practice at some companies.

This was evident in the article by Mina Kimes, Why J&J’s Headaches Won’t Go Away that recently appeared in CNNMoney.2 The article tells about the finger pointing within McNeil over repeating tests in order to bring the average into the passing range.

Apparently some involved felt a twinge over participating in this unacceptable practice known in the industry as “testing into compliance” or “reflexive retesting” in order not to reject the batch. (This practice became taboo as part of the legendary federal case against Barr Laboratories in 1993.3) The quality employee was quoted as being resigned to “doing what you’re told.”

The author ultimately concluded “quality oversight declined.”

Recent industry events should serve to remind company management as well as the QCU that nothing good—personally or corporately—ever came out of succumbing to pressure to do the wrong thing. In fact, company management should make every effort to be accessible by establishing ombudsman programs and hotlines into neutral territory (e.g., Legal Department) where individuals can confidentially report concerns.

Anyone who has worked in the QCU of a pharmaceutical company has had his or her mettle tested at one time or another. We have all been in the situation where we have had to stand by an unpopular decision. In some cases we were the lonely voice crying out against the louder, more powerful ones. But we’re not the only ones who have had to deliver and defend bad news. It comes with the territory and sometimes takes spine.

For sure, the QCU is no place for invertebrates.

1Federal Register Vol. 43, No 190 – Friday, September 29, 1978, Preamble to the Drug CGMPs.

2CNNMoney:  Kimes, Mina, 8/19/10, Why J&J’s Headaches Won’t Go Away,

3United States vs. Barr Laboratries, Inc. Civil Action No. 92-1744, US District Court for District of New Jersey: 812 F. Supp. 458. 1993.

The QA Pharm

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