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The QA Pharm

FDA Compliance

Four Reasons Companies Come Under a Consent Decree

And a short survey to see where yours stands

Published: Wednesday, June 17, 2015 - 14:42

When you peel back the layers of causes leading to serious FDA enforcement action, it comes down to a handful of fundamental reasons.

1. Management doesn’t know what is required

Executive and senior management might not have regulatory experience. MBA programs may offer courses on quality, but usually they are more about the popular concepts of lean manufacturing, not the Federal Food, Drug, and Cosmetic Act or the Code of Federal Regulations and current good manufacturing practices (CGMPs). Some executives may go so far as to think that if their companies are doing Six Sigma, they have a quality program.

If you have a true quality program, you have the FDA base covered. Executives seem to make a mental disconnect when it comes to CGMPs and usually don’t see them as legal requirements. However, it just so happens that CGMPs are also a business enabler that drives reliable processes, product quality, and uninterrupted patient supply. Management must acknowledge and embrace these legal requirements just as much as it does requirements of the Securities and Exchange Commission (SEC), the Environmental Protection Agency (EPA), the Equal Employment Opportunity Commission (EEOC), and other business regulatory agencies.

2. The quality department lacks the capability to detect problems and report to management

Management may demand regular status updates on how well the market in Europe is responding  to a new product launch, or how the new ad campaign is affecting the southeast sales region. But management often flies blind when it comes to knowing, at any moment, whether the operation is in a state of control. That knowledge is thought to come with regulatory inspections. The organization deals with the inspectional observations form FDA 483, and that buys time until the next inspection. The quality department often goes along with this reactive mode of problem detection because that’s when resources are most likely to be justified. The quality department must develop the systems and the capability to detect unacceptable trends, and be empowered to report problems directly to management. Such a mindset is essential to move from a reactive to a proactive organizational culture.

3. The organization can’t plan and execute permanent solutions

It’s one thing to know about a problem, and something else entirely to do something about it. The best position to be in prior to a regulatory inspection is to be able to say, “There’s nothing you will find that we don’t already know about. Not only do we have a plan to address these problem, but also our plan is on schedule.” But all too often, projects to prevent failure move to the bottom of the priority list for available resources. If they do get funded, the projects aren’t directed toward a permanent solution, or managed to a verifiable conclusion. Not only must compliance projects be resourced and managed, they also require oversight and governance to ensure that they are supported and completed on time.

4. Lack of integrity

Then we have the phenomenon of doing whatever it takes for self-preservation, which comes before the health and welfare of the patients we serve. No degree of knowledge of the requirements, or the presence of highly effective detection and escalation systems, can prevent dishonest individuals from violating public trust. What we can do is have a zero-tolerance integrity policy that is part of every employee’s training curriculum, and to make it safe for someone to voice her concern, should she witness a violation. In addition, training on good documentation practices will help standardize record entries and the process for documenting the correction of errors. This will counter the perception of fraud for honest mistakes. Those dishonest individuals? Well, that’s another matter.

Opinion survey: Reasons companies come under consent decrees

The time for introspection is not when the FDA starts moving against your company. Take this quick survey and use the results in an internally facilitated discussion. Now is the best time to assess your quality strategy. How would you rate your company? What are the implications for your collective results? Most of all—take action.

5 = Strongly agree
4 = Agree
3 = Neither agree nor disagree
2 = Disagree
1 = Strongly disagree

_____ a. Our management demonstrates visible support for CGMP projects to ensure our compliance position is strong.

_____ b. Our quality department has robust processes that provide management with the means to know the state of control and to take decisive action.

_____ c. We have a good history of directing teams toward potential compliance problems and finishing on time.

_____ d. We have an integrity policy, and everyone knows how to report confidentially a potential violation.

First published March 26, 2015, on The QA Pharm.


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The QA Pharm

The QA Pharm is a service of John Snyder & Co. Inc., provider of consulting services to FDA-regulated companies to build quality management systems and develop corrective actions that address regulatory compliance observations and communication strategies to protect against enforcement action. John E. Snyder worked at the lab bench, on the management board, and as an observer of the pharmaceutical industry for more than 30 years. His posts on The QA Pharm blog are straight talk about the challenges faced by company management and internal quality professionals. Synder is the author of Murder for Diversion (Jacob Blake Pharma Mystery Series Book 1).