Current Pharmaceutical Industry CGMP Compliance Trends

It must be that time of year 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.

So with this edition I offer my opinion not only to those conference planners, but also to my readers. After all, why should you—my loyal readers—have to attend a pricey conference to hear what I told them?

But first, a note about—well, these pricey pharmaceutical conferences.

There are worthwhile conferences in our industry, but you really have to consider whether they are worth the price of admission. I have always thought that the best conferences were those with a strong FDA presence on the speaker roster. However, FDA speaker materials eventually become accessible to the general public. So, shortly thereafter, you can Google the name of the FDA speaker you saw in the pre-conference e-brochure and bingo. If it’s content you’re after, why not use your favorite search engine?

The worst conferences are those that recycle the same industry consultants—free advertisement. I'll save that subject for another time.

So—now to the subject at hand: current pharmaceutical industry CGMP compliance trends. Here are the top three, in my opinion:

1.    There is an emboldened FDA intent on measuring up under a keenly interested Congress.

·       There are sixteen (16) major pharma consent decrees dating from 1989 to 2010. What do they all have in common? No, it’s not bodies in the street. It’s GMP violations. Of these, only six (6) consent decrees have been vacated.

·       Eric Blumberg, FDA Chief Deputy Counsel for Litigation, has been saying for the last ten (10) years that the FDA cannot expect progress until individuals are criminally charged. We’re starting to see that now. (Enter stage left: KV’s Marc Herelin, InterMune’s W. Scott Harkonen, Forrest’s Solomon, Glaxo’s Lauren Stevens.)

·       Margaret Hamburg, FDA Commissioner, said that the FDA will no longer issue multiple Warning Letters. Criteria have been developed for selecting cases for criminal prosecution of individuals.

2.    When there are repeated observations, the FDA questions the willingness and ability of the Quality Unit to exercise its responsibility.

·       Repeated FDA483 observations are considered a failure of the Quality Unit, as stated in numerous Warning Letters.

·       Warning Letter language recognizes that Quality Unit failure may be attributed to either an unwillingness to exercise its responsibility, or an inability due to lack of independence.

·       Recent high-profile cases have ineffective quality units in common.

3.    FDA expects the global deployment of the Quality Management System and oversight by corporate management.

·       Corporations are expected to have oversight of the quality and regulatory compliance of their operating units.

·       Some companies have “flattened” their organizations into non-compliance and lack of oversight upon the questionable advice of efficiency and cost-reduction experts.

·       The Parke Doctrine holds management responsible although they may not have been directly involved or aware of violative conditions. Some of these individuals have appeared before Congress.

Now, here’s the funny thing. One conference planner asked if this anonymous blogger would agree to be a speaker. What part of “anonymous” didn’t they understand?

Perhaps I could make it work? Perhaps a backlit screen projecting my trademark silhouette?

The QA Pharm

Leadership in Consent Decree Crisis

It’s a most unfortunate ailment of epidemic proportions that the approach taken by many when addressing underlying CGMP compliance issues is effectively based on a checklist mentality—a “To Do List.” For sure, solving fundamental regulatory compliance problems involves tactical work that is broken down into discrete executable steps. However, I become more convinced every day that the most significant challenges in life—regulatory, or otherwise—are more about “being” than “doing.”

“Being” requires an examination of personal character and motives. It takes a deep dive into ones willingness and ability to put self-serving interests aside and share a common vision—and for Pete’s sake—work together.

Working together is hard work in the best of circumstances, but when faced with transforming an organization from non-compliance complicity to embracing standards and discipline, there is no room for silos and bunkers. What is needed; however, is a central figure—a standard bearer—that rallies the troops and encourages them to great achievements in the face of insurmountable odds.

So when the implication of a consent decree finally sets in, and when you realize more than ever that the all troops need to march in the same direction—what do you do?

1.    Be the visible leader.

Face it. Most company management couldn’t find packaging line number 3, not to mention know how to converse with a second-shift hourly worker they have never met. But leadership soon recognizes the need to reach out to everyone, and becomes a quick study on how to do it. A leader is personal and accessible in times of trouble. Everyone needs to know and see who is in command of the situation. Lack of visibility builds distrust, and folks start thinking about their employment options.

2.    Accept responsibility.

Blaming the FDA for a tough inspection is not the way to be credible. The workers know better, and chances are, they have been trying to tell you for years about what hasn’t been working. Leaders accept full responsibility no matter what. It becomes readily apparent to the rank-and-file whether or not there will be any significant improvement by sizing up management acceptance of responsibility. Without it, there is no reason to expect any lasting change. That’s when folks dust off their resume.

3.    Rectify the situation.

Fix the problems. Fix it with your regulators, your customers and your employees. Chances are that production has stopped, workers’ hours reduced, and inventory is depleted. When it’s all over, make it right with everyone. Make them whole. Regain their trust. Your ability to compete and survive depends upon it. Your customer base and eventually your stock price are a vote of confidence. Efforts must be aligned and focused on the real problems, even if the real problem is management. When employees don’t see the real issues being addressed, they see the clock ticking and start floating their resume.

4.    Solicit help.

Admit when you need help. You may have been rewarded in the past for your lean machine. But if you look around and find that your most experienced technical people took the early retirement program as part of your reduction in workforce program, swallow your pride and hire them back as consultants and contractors to help out. They will be happy for the work, and the going hourly rate will be far more than they were paid when they worked for you. But it will be worth it to them. Consulting groups are often necessary—even mandated by the court—but remember: you run your company. You have to sustain the operation when they leave. In the end, the support must be coordinated to avoid chaos. Don’t just turn them loose. When things get chaotic, people start interviewing.

5.    Be open, honest and fair to employees.

Don’t make false promises. They would rather hear the truth—from you, not the locker room. However, most of the solutions to the real problems lie with the people doing the work. Invite them into the process of fixing the problems. Your credibility will be based on their prior experiences. If you need key people to hang in there with you, make it worth their while with retention incentives. If you need them, give them a good reason not to jump at the next good offer.

6.    Communicate.

Communicate the problem, the plan and the progress. Make the communication personal. Employees know the difference between when a PR firm has written your sound bites and a message from the heart. Single sites are easier than corporate networks to communicate, but figure it out. It still needs to be direct and personal. Forget about keeping secrets thinking that this regulatory-legal type work is super sensitive. Everything is available on the web or Freedom of Information. Secrets are sometimes so well kept that people doing the work don’t know what commitments have been made to the FDA, or what they’re supposed to do. That’s when you’ll look around and find nobody there to communicate to. They’ve gone to the competitor.

So, while you’re occupied with “doing,” don’t forget the “being.”

The QA Pharm

Consent Decrees—It’s about Sustaining Compliance

By the time a consent decree comes along, it’s no longer a discussion about responses to observations replete with well-turned phrases—it’s about a DIY Network renovation—a complete makeover. It’s a “gut-it” approach, as never before, which exposes the cracked foundation and termite-eaten beams weakened over time.

This is because the common element of a consent decree is demonstrating—sustainability. As in “over time.” That takes more than a fresh coat of paint.

Regardless of the huge effort and expense to redesign and implement a more robust Quality Management System (QMS), the real test comes afterwards—sustainability.

Long after the consultants have pulled up their tent stakes, the project plans flawlessly executed, the senior management dashboards faded away, the real mettle is yet to be tested—sustainability.

“Sustainability” is an attribute that is difficult to achieve under normal circumstances, not to mention under the supervision of the Department of Justice.

Geesch…can’t a person make an honest mistake anymore?

Is “sustainability” the same thing as “perfection”?

I sure hope not. If it is, we’re all screwed.

I prefer to think about “sustainability” in a more realistic way. Sustainability is the capability of an organization to know when it is veering off course and the ability to make the right decisions and take the right actions to re-center itself (without external intervention) to maintain a state of control.

Like in the human body, it’s an inherent homeostatic mechanism that monitors the manufacturing and quality process signals and responds accordingly to maintain healthy control of product quality.

“Sustainability” touches—nay, embraces—subjects such as values, culture, expected behaviors, empowerment and accountability. These don’t sound much like terms in the CFR. But the demands of sustainability require nothing less than organization transformation: from something, to something else that it wasn’t before—a makeover.

One thing for sure it is not. It’s not the FDA telling one over-and-over again about the same problems. In fact, consent decrees mandate a series of annual inspections performed by a third-party to determine sustainability, so FDA doesn’t have to.

In other words, FDA has already determined the recidivism of the defendant, and now they look for the third-party to spend their time and the defendant’s money to inspect and certify compliance—often for many years—measuring sustainability. Not FDA.

To achieve the attribute of “sustainability” is not easy, but worth pursuing under usual circumstances. Why wait for an injunction?  The often-surprising benefit of the makeover is operating in the “sweet spot” of economic control of quality and providing a continuous supply of quality product.

Consent decrees require an entirely different kind of response than usual, because a different kind of result than usual is expected—sustainability.

Sustainability—and the organizational capability to achieve it—that’s the goal.

The QA Pharm

The Crack in the Wall: Unintended Consequences of Authority

I remember when I was a freshly minted executive taking a window tour of the manufacturing facility. While listening to a staff member talk about the operation, I idly traced my fingertip on an ever-so-slight mar on the finish of the corridor wall, as I was lost in thought. Little did I know the chain of events that this little action would set off. By the time of my next walk into the manufacturing facility, the entire corridor was freshly refinished.

It often is with executives: a simple word, glance or unconscious pause—in my case the mindless wandering of my fingertip—has surprising effects.

Once there was a pharma exec that stated flatly that certain software was the company standard. Little did he understand that an alternative software that was justified and better suited to a unique situation had been in play for months. But his comment set off a fury of activity by dozens of employees that worked tirelessly over months to convert the data and retrofit it into the awkward “company standard” at great expense and loss of precious time and effort to deliver on commitments to the FDA.

In another example, a pharma exec questioned the timing of a purchase order request for a controlled temperature chamber for the stability program. The simple question of timing sent the requisitioner back to try again next quarter. Little did the exec know that this equipment was needed to fulfill a commitment to the FDA, and that there was a six-month lead-time to acquire it.

With authority comes unintended consequences: the rank-in-file hesitates to question it or push back on it.

Rather than creating a situation where the humble creatures fear to approach the mighty Oz, it would be helpful if the executive would take time to invite conversation about the request.

However, shame on the person who fails to make the business case, and the person who walks away fully knowing the unintended consequences of the denied request.

I have never met a company executive—whether a blustery curmudgeon, or a charismatic leader—who does not speak the language of money; who does not abhor squandering resources; or who is not willing to pay now to avoid a problem with the FDA tomorrow—when the proper business case is made. (Well—almost never.)

And—where was QA during the countdown to the day of reckoning with the FDA?

Fear is alive a well in corporations. But fear is really the result of the lack of confidence; not being prepared; absence of skills to defend a point-of-view; and often haunting memories of boogey men of the past. In short, it’s lack of conviction and courage.

Debate is productive. Contrarians sharpen the decision process. We would all do well to encourage it.

The QA Pharm