New Years Resolutions for Pharma Quality Assurance

Like anyone else, coming to the end of the year brings a time of reflection and anticipation. I look back and ask the question, "Have I made a difference in anyone's life?" I look forward and ask, "What do I want to change that I either have control or can influence?"

For the pharmaceutical professional, these questions are not only personal--but professional.

The Quality Assurance professional should always have the sense of a high calling. That calling needs to go beyond being the "checker" who culls out the defects to being the applied scientist or engineer who helps to design quality into the product.

This reminds me of the dear soul who proudly showed me the bucket of discarded product that she plucked off the conveyor belt. The occasion was a plant tour to understand how this company saw the role of the quality function. The next stop on the tour was the QC lab that was backed-up with samples. The analysts were randomly selecting their favorite tests to squeeze in before their next coffee break. It didn't take long to determine that the view of the quality function at this client was anchored in---approximately the 1950s.

On the other hand, there are companies on the cutting edge science and technology with breakthrough products that fulfill the dire need of desperately sick people. Yet, in their evolution, these very bright people did not pay sufficient attention to FDA compliance.

Looking back...

As I look back, I see pharma companies ranging in their quality assurance evolution from knuckles still dragging the ground to walking upright, but tripping over their own feet. So there is still plenty of work to do, and the enlightened--and bold--quality professional is not short of ground material to make a difference.

I say "bold" for a reason. In my opinion, the single factor holding back the quality professional, and consequently the company is the lack of courage.

The economy is not to blame for everything, but working on the inside of just about any company is an environment that is fraught with fear. Timidity is rampant. It is rare to find someone who has the balance of panache and guts to tell the Emperor that he is butt naked. It is a game of not making waves, keeping your head low--and for Pete's sake never pointing out a problem to your manager that makes him have to speak to his director. (Like that's going to happen.)

Looking forward...

My prediction is that the winnowing process will continue in our industry and those with neutered quality assurance departments will either be acquired and rehabbed--or fail. In true Darwinian fashion, the fittest will survive to reproduce.

Regardless of the situation, I would suggest these resolutions for the quality assurance professional:

1. I will make myself more valuable through continuing education that will make me a more enlightened quality professional. These will include real courses from recognized institutions, not trendy certifications.

2. I will find my voice and speak up when I see unacceptable quality and regulatory compliance risks. I may need personal coaching on how to deliver negative messages, but I will not stop going up the chain of command until I am satisfied that reasonable action has been taken.

3. I will learn how to make the business case when I see an opportunity for improvement. As a professional who has been conditioned not to be influenced by cost, I need to learn to how to develop and deliver proposals that speak in the universal language of business---money.

4. I will get out of my cubicle to see what others are doing to broaden my industry perspective. I will resist the notion that my daily working experience is necessarily typical of the industry.

5. I will understand how my role fits into the business process cycle and will hold myself accountable for results, even if the results are bad news. This may mean developing standard cycle times and finding efficiencies to complete my part on time.

6. (And my personal favorite) I will no longer prepare a useless slide deck for a management presentation on "what went wrong and recommendations" until management has supported the recommendations from  the previous presentation for the same problems that went wrong. I give myself permission to expect more out of management, especially when it comes to doing my job right.

Happy New Year!


The QA Pharm

Top Ten Ways to Make GMP Training Relevant

Most GMP training that I encounter is not necessarily bad--just irrelevant. In fact the same could be said for the Training Department. They jealously guard their turf and deliver mediocre, perfunctory training. Names get checked off the list, and the Training Department goes about their business being irrelevant. (Ouch!)


There is nothing that could be more exciting and fulfilling than being part of a dynamic training group that equips its organization to be a finely tuned work force of scholars that embrace GMPs as a business enabler.


Unfortunately, rather than a graduate education in the pharmaceutics of regulations, our best and brightest are subjected to a mind-dulling deck of tired old PowerPoint slides.


Frankly, the problem is endemic and here's why:

1. The concepts are not applied to the real world. We herd the mignons into the cafeteria and deliver the obligatory annual GMP training with total disrespect for what each employee does as part of his/her job everyday.

2. Training topics are not strategic. The lack of the broader view of the state of the industry and regulatory enforcement trends keeps GMP training from being proactive or responsive to the changing regulatory environment.

3. Training is not data-driven. The topics selected are often disconnected from the problems at the site as revealed at quality metric review forums such as Quality Management Review.

4. Training is the ubiquitous excuse (punishment) for corrective and preventive action. The easy out is to say that a failure can be addressed by training without truly determining the root cause.

5. The training method is not effective. When everything from a step change to a total system re-design is handled by "Read and Understand," it is difficult to distinguish between minor and really significant training topics.

6. The trainers are dreadfully boring. It's amazing how much we devalue the importance of training as evidenced by the little emphasis we place on the design and delivery skills we place on the people we put in those positions.

7. Lack of attendance is tolerated. When there is a conflict in one's schedule, the training class is always the loser. Nothing ever happens if you don't attend, because usually know one knows. No one really cares.

8. Leaders don't go to training either. It's comes down to not really expecting leadership to be trained, as though there is some special dispensation with the privileged class. They certainly aren't examples to follow.

9. The priority of the production manager is getting product out the door, not the skills and capability of his/her workers. In fact, he/she may be totally unaware of whether the workforce is getting the right training, or current with meeting individual training requirements.


10. Measurable improvement in skills and knowledge is not rewarded. We reward what we value, and training isn't it.


So, class, here's your assignment:


Turn each of these negative statements into a positive one. Then perform a self assessment of your organization against these statements.


Don't be defeated if the results are pathetic. You are in good company. It's all about what you do with the information starting right now. 


Turn these into vision statements. Discuss the practical, measurable steps you can take to improve the relevance of your GMP training.


Keep it going, and watch amazing things happen!



The QA Pharm

Where were you on September 11? Let us never forget.

I remember exactly where I was and exactly what I was doing on September 11, 2001. The time and place have been indelibly etched in my brain.

It was Washington, DC where I heard the announcement. I heard the sirens and saw the army helicopters fly overhead and patrols of army vehicles in the street. It was am image of a city under siege. The burning, crumbling Twin Towers and the caved-in Pentagon were replayed on the news channels. Eventually the reality of it all sank in--our homeland was attacked.

Then the news came out about Flight 93 downed in Shanksville, PA. "Let's Roll" became the rally cry of my personal heroes onboard the plane that fateful day. I was within spitting distance of the Capitol Building at the time, the likely intended target.

I passed many makeshift memorials on my walk to the train station for my failed attempt to find transportation to just about anywhere. The Capitol flag was at half-mast. People milled about. Strangers talking to strangers. I felt anger and pain for our country.

The memorial service at the National Cathedral was going on in the Admirals Club the day I was able to fly out of Dulles. Travelers turned their chairs to face the television. Little-by-little the club turned into a sanctuary. There were tears. There were prayers.

Nothing would be the same, other than our resolve to not to let our enemies take away our lifestyle. I felt a surge of patriotism and a sense of duty, and I knew that I would never be the  same.

So in honor of September 11th and all those who gave their lives--and my heroes buried among the ashes in Shanksville--I am getting on an airplane.



The QA Pharm

Decisions and Indecision—The Organizational Vortex

The cover of Fortune magazine popped off the newsstand shelf last week: What Happened at Pfizer: The Inside Story of Revenge, Betrayal, and Power at the Top of the World’s Largest Drug Company.” (August 15, 2011)

Amidst the story that recounted epic boardroom intrigue, one section described the impact that these political shenanigans had on day-to-day decision-making.

“A second anonymous letter, claiming to be from ‘responsible, long and loyal Legal Division employees,’ arrived on the very day of the board meeting. It complained of ‘micromanagement,’ ‘constant’ internal reorganization, and a ‘chaotic’ decision-making process. ‘A decision is made, then reconsidered and changed. Decisions, even minor…are picked apart and often directed to be undone. Then re-studied. Then the decision-making group expands. Paranoia results. Autonomy is sapped.”

When it comes to fuzzy authority and recycled decisions, Pfizer is not alone. Wherever it occurs, at whatever level, the organization is seriously impacted. It matters how decisions are made. Nothing is more revealing about the leadership and the future of an organization than how decisions are made.

One of the most fundamental responsibilities of top management is to align the organization—to get all the oars of the scullers in the water pulling in the same direction. When company leaders compete for the megaphone it becomes, “Stroke, no don’t stroke. Pull left; I mean right—now, anyway.” The course is convoluted, not straight; energy is wasted, not conserved.

When there is leadership dysfunction, there is organization dysfunction and ultimately the patient suffers. Yes—the patient.

Whether it is getting the organization aligned to resolve its regulatory compliance problems, or on time order fulfillment, it is clear lines of authority and crisp decisions that lead us across the finish line.

So, if you feel sometimes you are in an organizational vortex of ineffective decision-making, my recommendations are these:

1.    When you accept an assignment, be clear about who are the reviewers and approvers. A good Responsible, Accountable, Consulted, Informed (RACI) model applies here.

2.    Establish a charter with a clear scope, lines of communication and decision-making authority. Have your oversight committee approve.

3.    Before you are asked to present to your oversight committee, be sure to clarify whether your authority extends beyond recommendations to decisions. If you are the decision maker, walk the committee through your logic.

4.    Clarify what decision was made. After the presentation to your oversight committee, sum up the decisions. Don’t leave until every decision is crystal clear.

5.    If you were charted with decision-making authority, but your oversight committee takes it out of your hands in a meeting, ask for an explanation. Otherwise, you have no basis of moving forward.

6.    Capture minutes of decisions. Whenever you sense that you are having a “Groundhog Day” meeting, remind the participants that the issue had been discussed and decision had been made as recorded in the minutes.

7.    If anyone on the oversight committee starts to lobby outside of the committee to change the decision, stop it dead in its tracks. Indicate to that person that the decision was made.

8.    When you detect dissention among those of equal authority and it impacts your ability to make progress, meet with them collectively with the stated objective to achieve unified direction.

9.    Document a decision timeline. Nothing points to the effect of poor decision-making than a timeline of direction, redirection, and reverse direction. You may need it when you are asked why your project is behind schedule.

10. Protect your team from the effects of poor leadership decision-making. Make forward progress where you can; assume you make the decision. Resist all temptation to promulgate the organizational vortex.

Don’t be the victim of a dysfunctional environment. You may not be able to take complete control, but you can take steps to minimize its effects.

The QA Pharm

The Top Ten Warning Letter Observations about the Pharmaceutical Quality Unit

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 regularly review Warning Letters on the FDA website.

Here’s my condensed list of issues the FDA has had with the Quality Unit as seen in Warning letter observations.

This is the list you don’t want to be on.

1.    QU failed to establish a system to ensure that…[fill in the blank for anything that went wrong]

2.    QU failed to document the responsibilities applicable to the quality control unit in procedures, and fully perform these responsibilities.

3.    The personnel performing laboratory tests… were not trained.

4.    QU failed to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products.

5.    QU failed to fully perform and/or document the review of batch production records to determine compliance with all established, approved written procedures before a batch is released or distributed.

6.    QU failed to ensure that all tests are in conformance with the established specifications and that these are met prior to the release of drug products for distribution.

7.    QU did not review production records to assure that no errors had occurred or, if errors had occurred, that they had been fully investigated, conclusions made and followed-up.

8.    QU failed to investigate complaints involving the possible failure of a drug product to meet any of its specifications.

9.    Failure to submit NDA-Field Alert Reports (FARs) within three (3) working days of receipt of information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the distributed drug products

10.  And my personal favorite…a designated QU has not been established.

The QA Pharm

The Top Ten Responsibilities of the Pharmaceutical Quality Unit

The pharmaceutical Quality Unit has been the target of many FDA Warning Letters for not establishing an effective system to prevent product quality and CGMP compliance problems. 

We have seen instances where the ultimate “no confidence” vote is cast when third-party experts are either recommended by FDA, or court ordered to take over their duties. (See The QA Pharm 9/25/10.)

Therefore, it’s very important to have a clear understanding of the regulatory responsibilities of the Quality Unit and to ensure that those responsibilities are effectively executed.

Remember—the Quality Unit is the only job description that appears in the Code of Federal Regulations!

Here’s my compiled list from FDA regulations and guidance documents that defines the job of the Quality Unit.

(It’s like being given the answers in the back of the book—and not just the odd-numbered problems.)

1.    To establish the quality system

a.  Establish the quality management system to describe how the firm complies
CGMPs and operates to maintain a state of control

b.  Keep current with good industry practices, and applicable to the mission of your operation.

2.    To audit compliance to the quality system

a.  Audit for compliance to policies and procedures: on paper vs. practice

b.  Report on the performance of the quality system, including trends, that help
decision making for targeted actions

3.    To establish procedures and specifications

a.  Ensure that procedures and specifications are appropriate and followed

b.  Ensure that the procedures and specifications of firms under contract are also appropriate and followed, i.e., maintain control and take responsibility for third-party services providers (contract manufacturers, contract laboratories, etc.)

4.    To establish manufacturing controls

a.  Ensure that appropriate manufacturing in-process controls are implemented

b.  Ensure in-process controls are performed during manufacturing operations and results are satisfactory

5.    To perform laboratory tests or examinations

a.   Perform laboratory testing of components, containers, in-process materials, packaging materials and drug product using validated methods against scientifically-derived, fit-for-purpose specifications

b.  Approve or reject drug products manufactured, processed, packed, or held under  contract by another company, i.e., final product release is not delegated to a contractor

c.  Perform retests or reexamine approved components, drug product containers and closures after long storage or exposure to adverse conditions

6.    To review and approve or reject all things CGMP

a.  Review and approve/reject any document that gives work instructions and set requirements such as procedures, protocols, test methods, and specifications—including changes to these documents

b.  Review and approve/reject reprocessing and rework procedures

c.  Review and approve/reject production batch records and make the final decision to release a product lot into commerce.

7.    To ensure investigation of nonconformance

a.  Ensure investigation is conducted and root cause is eliminated for production and control record errors, discrepancies, and failure to meet specification, including quality attributes

b.  Review complaints to determine if it relates to a failure to meet specification, if so investigate and report to FDA if it is serious and unexpected

8.    To keep management informed

a.  Report on product, process and system risks—and keep management informed

b.  Report on outcome of regulatory inspections and ensure responses are complete and managed to verifiable closure—and keep management informed

c.  Keep management informed—get it?

9.    To describe responsibilities in writing

a.  Have a complete and compliant procedure that describes responsibilities

b. Follow the procedure

10. To remain independent

a.  Ensure there is no conflict of interest between regulatory responsibilities and actual daily activities

b.  Be independent reviewer and approver with respect to manufacturing and process/ product development units

How does your Quality Unit compare?

Please contact me to discuss how we can work with your senior staff and quality leadership to ensure your Quality Unit has robust processes to fulfill its regulatory responsibility, as well as help you to become an anticipating organization--rather than reactive.

The QA Pharm

References

• Federal Register Vol. 43, No 190 – Friday, September 29, 1978, “Preamble to the Drug CGMPs”
• The Code of Federal Regulations Part 210 and 211
• Guidance for Industry, Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (September 2006)
• ICH Q10 Pharmaceutical Quality System (June 2008)

Cartoon: The QA Quarantine Cage

The QA Pharm

Are Commitments Made to FDA to be taken Seriously?

Responses to FD483’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?

If these questions are not fully addressed in the FD483, then FDA will say so in the subsequent Warning Letter in the part where they acknowledge receipt of the firm’s FD483 response—and the inadequacy of it.

My first point is that there is no excuse for an inadequate response to an FD483 or a Warning Letter.

There are plenty of Warning Letters on the FDA website that provide examples of poor responses and what the FDA thinks about them. There’s no excuse for not knowing how to respond. (Also see The QA Pharm, October 10, 2010.)

Reasons for poor responses are:

·       Arrogance (What problem? Let me explain why we have no problem.)

·       Bad advice from house counsel (Dance around the edges, but never admit having a problem.)

·       Minimalism (Commit as little as possible and don’t look for other problems.)

·       Being far removed from the problem (Responses are so bad that it makes your technical insiders embarrassed.)

·       No root cause (Doing lots of stuff, but very little directed toward the real problem.)

·       Poor writing skills. (Difficult to follow the story line, because you have no idea what you want to say.)

My second point is never, ever miss a commitment date.

If anyone were to ask the leadership of any company under FDA enforcement action whether FDA commitments should be taken seriously, the response would be a resounding “Of course.”

Yet actions say differently.

It continues to amaze me how many companies miss commitment dates. And even more amazing—the senior management had no clue they had missed them. This is totally unconscionable and an indicator why the company has compliance trouble in the first place.

Reasons for missing commitment dates are:

·       No system to track responses and commitments

·       Responses and commitments are buried with hundreds of other TrackWise records, most of which are also overdue

·       Overly project managed until there is more planning than action

·       Lack of visibility as a standing agenda item in the management boardroom

·       No accountability at any level for results

·       Agency responses are kept a secret, or not sufficiently distributed to employees

·       Those responsible for doing the work had no idea that a commitment was made

The best way to think about the seriousness of a commitment to the FDA is to remember that the FDA already suspects a noncompliant firm to be untrustworthy—or at best they are neutral about their credibility. To not deliver on a commitment date just confirms their suspicion and puts the relationship between the firm and FDA on shaky ground.

Not providing an adequate response simply indicates being out of the mainstream of pharmaceutical industry know-how. And missing commitment

dates is nothing less that breaking a promise.

How would you feel if you were not taken seriously?

The QA Pharm

FDA Calls for Corporate Commitment and Leadership at PolyCarbon Industries

Just when you think that the FDA has to stick to the script by quoting chapter and verse of CGMPs, they get very progressive and offer straight talk about corporate commitment and leadership.

We have reported before that the FDA expects corporate oversight of the Quality Management System. (The QA Pharm 4/17/11.) The Johnson & Johnson debacle is just one recent example where the FDA cited the corporate folks for taking their eye off McNeil where Tylenol is manufactured.

But the Warning Letter to PolyCarbon Industries recently posted on the FDA website has an added dimension—a call for commitment and leadership. The Warning Letter dated December 2, 2010, reads as follows:

“It is essential that your firm establish and maintain a corporate commitment to an effective pharmaceutical quality system. Your firm’s management should demonstrate leadership and ultimate responsibility by participating in the design, implementation, and monitoring for quality throughout the company. Management should establish policies that describes your firm’s overall approach to ensuring drug quality and communicates your expectation of compliance with all requirements of applicable federal law and FDA regulations.”

There’s a lot of insight packed into this paragraph. The most important aspect is what commitment and leadership behaviors look like from an FDA perspective.

So, let’s do a little behavior analysis:

1.    Does your corporate group participate in the design, implementation and monitoring of quality at your company?

The best example of this that I have seen was a corporate group that facilitated a focused discussion of internal and external experts that led to the creation and deployment of company compliance policies.

The worst example was a company that hired a consultant to write the corporate policies. The policies appeared one day on the company intranet with the edict that they be deployed within six months. The old “right click on properties” revealed that the consultant had used the same policies for another client. The only thing different was the logo.

2.    Does your corporate group establish and communicate policies regarding regulations and compliance requirements?

The best example of this that I have seen was a company that deployed the policies with the business message that compliance was important to patients and the ability to compete. Compliance was to be valued and the operating norm.

The worst example was a company that couched the compliance message in terms of FDA inspections getting tougher, and that—right or wrong—the bar was being raised. “We just have to face reality.”

Regulatory compliance is no different than any other area of the company that requires commitment and leadership. Frankly speaking, when there is little leadership in this area, I find little leadership in other areas too.

So to our friends at the FDA, I say: “Spot on.”

Sometime what needs to be said can’t be referenced to the Code of Federal Regulations, but is truly at the heart of the problem.

The QA Pharm

What Does it Mean to Operate in a State of Control?

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.

The question was particularly germane to the purpose of my invitation, because these executives did not want to follow the path of other major industry giants into ruin by taking their eye off the proverbial CGMP compliance ball.

After a bit of awkward silence, someone offered a stab at the answer: Zero Defects. Another rebuked his colleague: That’s so passé. It should be Right First Time. The next ten minutes was Battle of the Buzzwords and I was the game show host. Conversation erupted in a murmur across the room.

I responded by saying that perfection was a worthy goal, but statistically impossible. I am highly suspicious of perfection, and firms that reward the strict definition of perfection drive bad behavior. In fact, when things are too perfect—I suspect fraud.

That quieted the room.

To operate in a state of control does not mean perfection. It does mean; however, the capability of a firm to detect and self-correct trends before it becomes a problem. And whenever a problem does emerge, the firm is capable of taking action to understand the reasons behind the problem, and make decisions that favorably effect the trend, or that prevent recurrence of the problem.

To make this more relevant, I drew an analogy with their Sales and Marking Department.

Their markets are broken down into regions and further into territories. Each territory manager has sales targets that they track and report up to the regional director. The regions report to countries. Eventually, all the performance metrics reach the company boardroom. Unfavorable trends and problems are investigated, decisions made and actions are taken. An eye is kept on the metrics to see if their decisions and actions were effective in increasing sales.

There is nothing here about perfection.

In this analogy, the market represents the Quality Management System and the regions and territories are its various parts organized by discipline. The territory managers, regional directors and the boardroom are the system owners and responsible management that exercise governance. Sales performance metrics are quality system performance metrics.

It was one of those beautiful “ah ha” moments.

  

I was intentionally being provocative with my question because I wanted this group that was responsible for a multi-billion dollar business to seriously consider how they were exercising stewardship of their pharmaceutical portfolio—for patients and investors.

What they expected to hear were Strategies for Avoiding a 483, but what I gave them was a refresher in Management 101 followed by one heck of a round of golf.

The QA Pharm

FDA: For Corrective Action Plans, Where are the Resources?

Can you 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 dry runs and dress rehearsals to hone their material before stepping into what they perceive to be hostile territory. Their presentations were carefully crafted by the VP, SVP, EVP and vetted by the lawyers. Consultants who claimed to have "been there and done that" were invited guests to the prep meetings to give their insight into what “sells” at the FDA. 

When the meetings at the FDA are over, the firm’s representatives heave a sigh of relief and offer each other congratulations that it went well, because it “felt good.” It “felt good” because no one on the FDA side of the table objected or got upset. So they go back to their colleagues and claim victory. The story gets exaggerated and turns into something like, “They really liked our presentation.”

In my experience, the only thing that “sells” at the Agency is results. The FDA “response” is a practiced, neutral expression that never is meant to signal agreement or acceptance. It’s all part of their “We’ll see it for ourselves when we come back to re-inspect,” modus operandi. 

However, we are starting to see a very interesting twist at FDA that suggests they have finally figured out that there is more they can do to ensure effective action than sit through fancy presentations acting nonplussed while having smoke blown up their proverbial tailpipe.

The new twist is embedded in the Teva Warning Letter dated January 31, 2011, but only recently posted on the FDA website. (The delay of which I always find curious.)

The theme of Teva’s Warning Letter is a problem of cross-contamination. Teva dutifully responded with their corrective action plan, which baited the usual response from the FDA--with a bit of a twist.

We recognize that your October 7, 2010 response states that you are in the process of developing a risk management program for control of cross-contamination of the products produced at the Jerusalem Oral Solid Dosage (OSD) plant. However, you did not submit that plan, or data to support the effectiveness of the plan, with your response. We also recognize your commitment to finish the risk assessment within four months. Please provide us with any update on your timeline, and the identification of resources allocated to address this issue. 

It is not uncommon for the FDA to expect a plan and timeline in a response. In fact, it is a frequent failing of companies to not provide a plan or timeline for completing corrective actions. However, in the case of Teva, FDA also requested the allocated resources to be identified.

That's the twist, and that's huge.

Frankly, this makes a lot of sense. The most successful corrective action plans have been those where the direct responsible individuals are named and appear in detailed project plans. There is a clear picture of what success looks like and how to get there. But most of all, the resources are identified to execute the work.

The regulation has always required sufficient numbers of qualified individuals to perform operations; so specifically asking about resource allocation to do the work is fair game. 
Unusual—but fair.

In the past, the sincere delivery of a good presentation might have passed with the usual skepticism. Now be prepared to tell about the resources to pull it off.

Without the resources, it's just another pretty presentation.

The QA Pharm

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