If there was any doubt before, then read the recent Warning Letter for the BMS facility in Manati, PR1 to understand the FDA expectation of how the Quality Assurance must operate within a pharmaceutical company.
Three phrases jump off the pages that should hit any pharmaceutical Quality Assurance organization in the proverbial solar plexus. These are:
“on-going problems…”
“failed to thoroughly investigate…”
“without adequate justification or scientifically sound statistical analysis…”
Tucked amidst three straightforward observations, these phrases attack the heart of the regulatory-mandated purpose for what the FDA calls the Quality Control Unit. (See The QA Pharm 8/28/10.)
In the case of BMS, the FDA made an unusual, but not an entirely unheard of recommendation:
“Engage a third party consultant having appropriate CGMP expertise to assess your firm’s procedures, processes, and systems to ensure that your drug products have their appropriate identity, strength, quality, and purity.”
In other words, hire a third-party expert to do your Quality Assurance Department’s job.
FDA further added:
“Repeat citations from prior inspections indicate that your quality control unit is either not appropriately exercising its responsibilities or does not have the authority to carry out its responsibilities.”
Ouch! That’s gotta hurt.
“So, which is it—unwillingness or inability?” asks the FDA. This is one of those double-bind questions like “Do you still beat your wife?”
It’s a very serious situation when the FDA is compelled to recommend a third-party CGMP assessment, which is in effect a “vote of no confidence” for your Quality Assurance Department.
So, if you are a Quality Assurance professional, ask yourself these related three questions:
1. Have manufacturing problems become routine with stock work-arounds, rather than infrequent with permanently engineered solutions? (i.e.,ongoing problems?)
2. Do investigations stop short of identifying the costly root cause and all implicated batches, rather than truly getting to the heart of the matter and full impact? (i.e.,failed to thoroughly investigate?)
3. Are nonconformance decisions rationalized based on operational and financial pressures, rather than justified based on scientific, objective data? (i.e., without justification or scientifically sound statistical analysis?)
If you answered any of these in the positive, then before consultants start circling your carcass, take a long hard, soul-searching look to determine the underlying cause.
Is it unwillingness or inability?
History bears out that when these core expectations are exercised well, there is better economic control of quality due to less manufacturing variation and supply disruption.
When they’re not, unpredictable production; regulatory agency enforcement; customer advocate group petitions; and stockholder lawsuits start sequential waves of attack—a pattern seen with most major regulatory enforcement cases.
In that battle, whether it’s unwillingness or inability, it is QA that always falls on the sword and is offered up as a sign to the regulatory gods that “once I was lost, but now I am found.”
So to the QA professional, I say: battle “unwillingness” by finding another line or work where there is less effect on the lives of other people. Battle “inability” by competence and the courage of conviction.
1FDA Warning Letter 10-SJN-WL-06, August 30, 2010.
The QA Pharm
Thanks for the great information. All of this FDA stuff is really confusing so I always hire a fda consultant when in doubt.
ReplyDelete