A Poster: Three Stages of Quality Management System Implementation and Oversight

A Poster: Three Stages of Quality Management System Implementation and Oversight

If I could summarize in one page the most important lessons I have learned in pharmaceutical Quality Assurance over the last 40 years, this is it.

This acknowledges that putting words in a procedure does not mean they will be put into action or be effective.

The responsibility of Quality Assurance is to ensure that an effective Quality Management System (QMS) is put in place procedurally, is in use behaviorally, and is in control measurably.

The responsibility of Management is to enable each element of the QMS by means of an identified owner; to provide oversight through performance metrics; and to promote the QMS as a normal and valued part of the business---not to make the FDA happy or pass an inspection.

As I reflect on my pharmaceutical career and the many clients I have served over the years, the best results and most rewarding experiences were with those who embraced this concept.

My hope is for all my followers to use this simple graphic as a way to communicate a QMS implementation strategy.

I would be pleased to support your effort with details behind each of these points.

If you would like a high resolution image, please write to me at my personal email address: snyderjohn@mac.com. You have my permission  to use freely.

The QA Pharm

Part 1: Responding to FDA483 Observations and Fulfilling Commitments

Part 1: The FDA483 Response

In this two-part series will discuss responding to the FDA483 and getting the work done to fulfill the commitments in a sustainable way.

Unlike a Warning Letter, a response is not required--but highly advisable. It is standard industry practice to respond to FDA483 observations. Responsible companies that want to have a good relationship with the FDA respond to each observation by saying exactly how problems will be addressed.

There is plenty advice available, even from the FDA, on what constitutes a good response. For certain, the difference between a good and a poor response may differentiate how you are viewed by the FDA.

From my experience, the following are points to consider that have worked well when forming a response:

• Do you agree with the response? Stating up front that you either agree or disagree, in part or on the whole, stages the rest of the response. Think twice before you say you completely disagree especially with everything-- because the FDA will always have the regulations, industry good practice, and the facts on their side. But it is quite possible that the FDA investigator got the facts wrong or drew the wrong conclusion. This is why a close-out meeting with investigators at the conclusion of the inspection is important. It is better to straighten out the record at the close-out meeting than in the FDA483 response.

• Defend what you are doing right. The examples of violations cited in observation are just a snapshot in time. Although you may not be proud of what was found, the finding may not be representative of the current state of control. The example may pre-date significant improvements that you have made on your own initiative, although they may be in progress and not fully implemented. Be sure to give yourself credit for such improvements. The last thing you want to do is give the impression that the FDA was the first to call a problem to your attention.

• Take product lot numbers seriously. When the FDA mentions specific lot numbers associated with a problem, it immediately puts you in the position of having to defend why those lots are still on the market, and why you have not shut down manufacturing associated with that product, process, or facility. Put your best minds and writers to work to lay out the defense of your release decision and the state of control. Be objective and use data. If you come to the conclusion, albeit late in the game, that the product should be recalled, seriously consider the right thing to do. Also take into account causing a critical drug shortage, because the FDA will work with you to avoid a shortage while you resolve inspection-related problems.

• Defend State of Control. Some types of observations paint a picture of being out of control, particularly when it is associated with validation, sterility assurance, potency, content uniformity--you know--the SISPQ issues. Also, taken collectively, observations that run the gamut of the quality system can indicate a precarious state of control. Take your best, realistic, honest shot at how you know you are manufacturing and distributing a safe, quality product. And, for goodness sake, do not--I repeat--do not anchor your defense that there have been no complaints or dead bodies in the street. Meeting all end product specifications may be the best defense you have if statistically treated, but be aware that a "final product spec" defense will always peg you as a 1970s time traveler.

• Commit to Action. Address the specific issues that were called to your attention, but do not stop there. Carefully determine the root causes of the issues cited in the observations. There will not always be a one-to-one relationship of root cause to observation. Nonetheless, run the problem to ground and understand what is behind the problem. Determine the action required to prevent the reoccurrence of the problem cited. Undoubtedly, the solution will require changes in multiple areas at the system level. Be sure to convey that you are taking system-level action, not just addressing the superficial, specific examples. Remember, observations are just examples. Indicate the action you promise to take and target completion date. Be clear in advance what "done" looks like and the specific deliverables that will provide the evidence of successful completion.

• Commit to Developing Appropriate Action. If you do not know exactly what all is necessary to fix the problem, it is completely acceptable to indicate that the scope of activities and target dates will be established in a plan to be provided later. But state in the response when the plan will be completed and provided. Major milestones and target month are usually acceptable in a follow-up communication.

• Recognize the Minimalism. Very likely you have taken a minimum essential approach to the commitment. By the time all the internal reviewers have edited the response, you have pared down the work to something manageable for normal business. However, the work associated with FDA inspection observations is not normal business. The scope of the actual work required to prevent recurrence of the observation may be more than expected when you actually delve into the root cause and prevent recurrence through systemic changes. 

• Provide Realistic Target Dates. There is always a balance between showing responsiveness with aggressive target dates and over committing to unrealistic dates. When dealing with operational and quality system problems, there may be more work involved than meets the eye. Some problems may require engineering studies or process development in order to understand the right approach to take when solving a problem. Take time to really think through all that is involved in order to provide realistic target dates. You don't want to go back to the FDA--at least not too often--to revise target dates. Do inform the FDA of changes in completion dates. Don't let a broken promise be a surprise when they return to reinspect. It's far better to inform them in advance.

• Engage Your Internal Associates. I cannot tell you how often I discover the situation where commitments and target dates were given to the FDA in very well written responses, but those who carry out the work were not involved--even totally clueless. It's best to involve those who have to fulfill the commitments in the actual writing of the response. Time is of the essence when preparing a response, but cutting out those who actually do the work will always uncover significant execution issues at the worse possible time.

• Take FDA Suggestions. When the FDA makes a suggestion about retaining a GMP consultant to assess your overall quality system and help you to improve--take the suggestion. This recommendation usually comes in Warning Letters where the FDA has come to the conclusion from the breadth of problems and recurring problems that there is no confidence in your Quality Unit or Management Oversight. Consider such a recommendation as a direct hit and taking on water, not just a shot across the bow. So be responsive and act accordingly.

What is your experience with preparing regulatory observation responses? What has worked well? What has not worked well?

In Part 2 I will talk about organizing to get the work done to fulfill commitments.

The QA Pharm

"Murder for Diversion" The first Jacob Blake Pharma Mystery by John Snyder

I started the QAPharm Blog three years ago as a creative outlet to share my perspective on the pharma industry and the quality assurance profession. I have appreciated my faithful readers from dozens of countries around the world.

As many of my readers have noted, I took a hiatus from blogging for a year. During that time I wrote the first "whodunit" murder mystery ever set the the pharmaceutical industry.

Murder for Diversion by John Snyder is the first Jacob Blake murder murder mystery, and it is available at Amazon for your Kindle. I hope you enjoy it.

Just like my blog, it is infused with my experience in the pharmaceutical industry, but it is a true work of fiction. All places, events and characters are the product of my imagination. 

Here's a little bit about my book and protagonist Jacob Blake.

Jacob Blake is reinventing himself.  He's an expert in pharmaceutical manufacturing quality, but his career and his life is at a crossroads, when an uncle dies and leaves him property in, of all places, Texas. He drives cross-country, thinking that maybe this is a sign, a direction for him to go.  But his old life calls, and his ex-boss and nemesis in Philadelphia asks him to take a look at a mystery.  His first inclination is to not look back, then his old boss is suddenly dead, leading Jacob into a world of shady dealings, and murder.  This is the first in a planned series looking at what the public doesn't know about how the drugs they take every day are made and following a character in his journey of re-creation and life renewal. 

So, if the book was written by John Snyder and I am QA Pharm, then QA Pharm must be John Snyder.

I hope you enjoy the book and continue to check in with me here at The QA Pharm. 

I am very happy to know you.

John Snyder
The QA Pharm

Drug Shortage: A Story of Self-Inflicted Management Tragedies

My blood boils when I read an article such as the one that appeared in the New York Times yesterday entitled Supply of a Cancer Drug May Run Out Within Weeks, by Gardiner Harris. This is one of many articles that has appeared lately about the mounting crisis of drug shortages across the country. This time it is the drug to treat acute lymphoblasic leukemia, which most often strikes children ages 2 to 5.

The article quotes the president of the American Society of Clinical Oncology saying that he hopes that the FDA's hard work can help avert a crisis. The FDA is always brought into the middle of the political quagmire of pharma companies, medical professionals and patients. But the FDA is not the "bad guy."

If you were to map the drugs that are in short supply to the FDA's Inspection Observations, Warning Letters and Consent Decrees, you will find a long history of problems that would have given any reasonable management plenty of time to permanently solve the problems.

The truth is that the problems are self-inflicted. There is not one problem that cannot be solved with the right management and the right technical and scientific expertise to establish a capable manufacturing process and facility.

Quality Assurance is not totally off the hook. Often QA cannot see the forest for the trees. They strain the gnat and swallow the camel. Often they are busy policing the proper use of indelible blue ink that they do not see the cumbersome, non-value-added administrative activities that are choking the quality management system.

I read Mr. Harris' article and though of my healthy grandchildren. Thank God.

My heart goes out to those patients who are dependent on life-saving drugs.

C'mon people get your act together!



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

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

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

The Qualitative Message of FDA483s

One of the first questions I ask a pharmaceutical executive is how he or she gets information to know that their quality management system is effective. On one occasion and after a slight hesitation, I had to re-phrase my question. The conversation went something like this:

“What I mean is: How do you know that your product quality assurance/ GMP compliance program is working well?”

“Oh, well—quality is a priority for me. I pay a lot of personal attention to our quality program. We have a lot of quality projects at this site.” He motioned out the window to the Six Sigma flag in the courtyard. “I’d love to give you a tour. We have posters of all our projects in the cafeteria.”

That wasn’t exactly the answer to my question, so I tried another approach. “How do you decide the projects to work on?”

Proudly, he replied, “We have self-directed work teams here. They are empowered to select their own projects that make their areas more efficient.”

“That sounds really special.” I tried to sound sincere. But now I was starting to worry. After all, the reason for my visit was to help him prepare for an FDA District meeting regarding his most recent FDA483.

I tried again, “How do you think you fared through your last inspection?”

“Well, that’s why I asked you here.” He pointed for me to take a seat. “Our FDA inspections have continuously improved.” He passed a trend chart to me and continued, “Our corporate risk management group keeps a rolling average of the number of 483 observations. We only had six observations this time—greatly reduced number compared to the last time. That brought down our average.”

I pointed to a dotted line running across the chart. “What’s this?”

“Oh, that’s the norm for our entire global network. These last inspection results brought us well below the corporate norm. So we’re looking good from a corporate perspective.”

“So this is how you get a picture of how well you’re quality management system is working?” I asked trying to keep the tone of my voice flat.

“Sure,” he replied confidently. “But it’s the damndest thing.” I let the comment hang a moment as I waited for him to complete his thought. “The FDA inspector was rather hostile. So I thought we’d better go pay a visit to smooth things over. Six—just six observations! The inspection was over in two days! It wasn’t but two years ago that the FDA camped out here for three weeks and gave us nineteen observations! That’s continuous improvement, isn’t it?”

I didn’t answer his question right away. Instead, I took a few minutes to review the FDA483’s from their previous inspections. It became abundantly clear what was going on between this company and his FDA district office.

The inspector went only as far as he needed to go to document that the same issues remained—then he simply quit and went home.

Management was high-fiving each other in the corridor at the relatively few observations calling the one-pager “a light one.” Evidently the FDA inspector left with a different impression.

Although this is the year 2010, the kind of thinking depicted in this dialog dating to the Paleozoic era is still around.

Here’s what I say to such fossilized specimens:

First, numbers of observations cannot be statistically treated. You can neither average them, nor calculate a relative standard deviation because the number of observations is not derived from a single, predictable, defined process. Inspectors differ; the scope of inspections differs; the length of inspection differs. So, you cannot pool the data and statistically treat to make any kind of meaningful inference. In this case, fewer definitely was not better.

Second, the absence of a negative comment does not mean agreement. For example, just because an inspector walked through the warehouse that was not temperature and humidity controlled to get to the receiving inspection area, does not imply concurrence with operating an uncontrolled warehouse.

Third, inspection results are a seriously lagging performance indicator—if not lethargic. Much like the company stock price, by the time serious lack of compliance has had its dastardly effect—it’s too late to stop the shareholder lawsuits. Additionally, inspectors do not look favorably upon their observations being the measure of compliance—or the impetus for a quality plan. In fact, boilerplate language in Warning Letters points out that the list is not intended to be an all-inclusive list of deficiencies. The expectation is for company management to know for themselves the state of control though established internal review processes.

Fourth, efficiency “projects” may not address, but rather cause compliance issues. Efficiency and compliance are two different things. Efficiency deals with the most economical way of working. Compliance deals with a consistent way of working that meets regulatory requirements. For example, a self-conducted survey by an active ingredient supplier of its own operation is very cost effective, but inadequate for meeting the requirement for you to know their capability of consistently meeting your specifications.

More important than the number of 483 observations is the qualitative message. Taken collectively, the qualitative themes in this example were: (a) inadequate management control, (b) inability to sustain compliance, (c) failure of the quality control unit to establish an effective quality system, and—what we are seeing more of lately—(d) lack of corporate oversight and action.

An appropriate response to the qualitative message should be considerably different than the quantitative one. The qualitative response reads more like an organization overhaul—organization transformation, while the quantitative response appears more technical.

Heed the qualitative message of regulatory inspection observations; don’t average them.

Patients Take the Individual, not the Average

Many decades ago, my high school science club sponsored a field trip to Eli Lilly. Our little group of longhaired and bell-bottomed kids (after all it was the 60’s) was ushered into a little room to watch the introductory video about the history of the company and Colonel Lilly. This was followed by a guided window tour by a Lilly employee who would never know that he started a sequence of events in my life that led me to the pharmaceutical industry.

I have often thought about that day, which gave focus and purpose to my academic studies. But these many years later, I mostly remember the tour guide.

I recall how he pointed to each piece of equipment and explained what it did, how it worked, why it was important to the process, and even who was important as he pointed to each operator in the area and told us their roles.

When we finally arrived at the end of the tour, our guide showed us the final product being filled and packaged and said that everything we had seen up to this point was important for each and every vial that was coming off the line. It was with a reverential awe that our guide said that each vial would be going to a person whose life depended upon it.

That tour guide got it right. Patients take the individual, not the average.

It is manifestly impossible to sample a sufficient quantity of finished product to assure the conformity down to the unit level. However, it is the unit level that is taken by the patient, sometimes daily for their entire life.

So, if we cannot provide adequate assurance down to the unit level by testing alone, and if it is important that we must for the sake of each use by the patient—then what gives? Is this a double bind?

The answer is in the Quality Management System.

The purpose of each element of the Quality Management System is to collectively work together to control the manufacture of the drug product from the suppliers’ materials received at the dock to the final product in the shipping containers coming off planes and barges around the world and onto hospital and pharmacy shelves—through to the end of the expiration date.

Each step along the way from dock to stock is based on science and engineering. The Quality Management System ensures that the science and engineering foundation is vigilantly protected from undesirable and unintentional variation that could negatively impact the product at the patient level. And if it does, the problem and product impact are thoroughly investigated and the underlying cause is engineered out.

This is the field of Quality Assurance. It’s all about the patient and the individual unit, as well as the controlling the way we work to ensure consistency and predictability. Patients deserve no less.