The Enterey Blog

PROACTIVE COMPLIANCE. How Does Your Organization Define it?

Posted by Tita Tavares on Tue, Aug 28, 2012 @ 01:18 PM

How Does Your Organization Define it? 

Generally speaking...
A Google search of the term “proactive compliance” results in a multitude of definitions. Wikipedia distills the term down to a simpler “proactive,” which it defines as: organizational behavior that is anticipatory, change-oriented and self-initiated, particularly in the workplace. Australia’s Department of Commerce even has a consumer-protection, proactive-compliance program designed to, among other things:   

Enterey Proactive Compliance 
  • Promote a culture of compliance by assisting agencies

    to understand and comply with legislative framework

  • Promote the use of compliance tools

  • Encourage high levels of industry best practice

Symantec, the world’s largest maker of security software for personal computers, takes an IT-oriented approach and states in their 2009 white paper that “proactive compliance describes an innovative...way of thinking about...compliance with industry regulations and standards.... Rather than focusing exclusively on the immediate need to pass an audit, proactive compliance entails looking beyond the audit and leveraging compliance efforts to drive (IT) operational excellence.” The paper goes on to admit that “unfortunately, for most organizations the reality is quite different. [With] regulatory requirements, tight budgets and limited resources, many companies adopt a highly reactive approach to compliance.”  

How Enterey Defines It

In May 2012, Enterey presented an interactive educational session on pre-approval inspection (PAI) readiness with input from former FDA inspector, and current Enterey partnering consultant, Mark Tucker, PhD. In this session, attendees spoke to their own pain points with PAI, and Enterey presented a successful PAI case study and illustrated the 5 essential questions every organization should ask prior to inspection.  

Tucker defines proactive compliance as “identifying potential problems before they become real problems.” He says that in traditional compliance, an audit is conducted and the findings are analyzed after the fact. But in proactive compliance, an audit is still conducted but processes are reviewed before they are executed, potentially eliminating and findings and saving a lot of time and re-work.  

In October of this year, Enterey CEO Mike Ferletic will give a presentation on proactive compliance in Germany at the 8th annual Fleming Europe meeting on Quality Operational Excellence in Pharma Manufacturing.


Creating Your Organization’s Definition

So, what does proactive compliance mean to your organization? If your organization is involved in R&D, it means changing the way you approach FDA audits and inspections. It means being compliant with regulations, anticipating and addressing any “skeletons in the closet” that could potentially come up in an audit and restructuring the company culture so that you can be ready--instead of reactive--for an FDA inspection.  

According to Tucker, proactive compliance has several other advantages, including:

  • A competitive edge, saving a time that would otherwise be spent on deviations, investigations, re-works, etc. 

  • Partnerships between operations and quality; those involved in quality gain a better understanding of business, and those involved in operations gain a better understanding of quality, building better leaders.

  • Increased company pride and morale.  If a company is constantly striving to be better--which is at the core of proactive compliance--then a company will make a better product, and employees will be proud of that product.

Are You Ready?

When the Parenteral Drug Association has its annual PDA/FDA joint regulatory conference in September of this year, will PAI be on your mind? Will you be engaged in proactive compliance and ready for anything the FDA might request? Or will you still have lingering questions that could ultimately impact your bottom line? 


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Published by Mark Tucker | Enterey Partner 

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Tags: FDA, Inspection Management, Inspection Readiness, Proactive Compliance, Quality Risk Management, PAI

Top Priorities of a Successful Inspection by Mark Tucker

Posted by Tita Tavares on Fri, Mar 09, 2012 @ 08:56 AM

All companies talk about conducting successful inspections but how many have clearly defined what a successful inspection is?  In this blog, I will talk about what I feel are key attributes in order for a company to deem their inspections a success.  


First and foremost, a successful inspection must allow you to obtain or maintain your right to manufacture and distribute a product.  Whether this is your first pre-approval inspection or a general GMP inspection, there are significant consequences for failing to get approval or to be found “out of a state of control.”  The inability to sell and market products caused by a failed PAI GMP inspection, affects not only your bottom line but the patients that need your products. 

The second priority for a successful inspection is to avoid less severe but still damaging regulatory or market actions, which include product withdrawals, product recalls, warning letters and even seizures.  While not as severe as losing the right to operate, these actions still affect the company financially by potentially causing a loss of revenue, a loss of market share, and a loss of stock value while also damaging your company’s reputation and opening the possibility for litigation.  

The above two priorities are critical to the success of the company.  However, there are other, less critical but still important, goals for managing inspections.

Minimize the number and scope of the findings:  I believe that many companies err in making this a critical outcome for an inspection to be considered successful.  While this goal is certainly important, it is more important in my mind to look at the bigger picture.  While you definitely want to minimize the number, scope and significance of findings, in some instances, it might be better to accept a finding rather than to continuing to “discuss” the issue during the inspection.  Inspectors are human, too, and if they feel you are arguing without merit (and if the goal is zero observations, this can occur), the tone of the inspection can be negatively impacted harming your ability to influence the outcome of a more significant issue later in the inspection. 

Maintain the confidence of the health authorities: You can damage your image with health authorities by the way you handle an inspection. Regardless of the outcome of the inspection, you need the health authorities to perceive you as being open and cooperative rather than closed and secretive. You need the health authorities to feel your company is committed to quality and doing “the right thing.”

Have few or no surprises during an inspection: If you have implemented a robust inspection management system that includes regular updates to Senior Management,   no one should be surprised by the inspection findings and outcome.  However, if there are surprises, it is important to review and assess your inspection management system to understand where there are still gaps and improve the system to try and ensure there is no recurrence.

Maintain good inspection logistics: By implementing a robust inspection management system, there should be good communication between the inspection room and preparation rooms.  Documents should flow smoothly and as requested after being appropriately vetted; presenters should be well-trained and informed of the current issue under discussion before interacting with the inspectors; and the right people should be available at the right time with the right information.  If you do this really well, you can minimize the effect of the inspection on your site’s operations. 

By defining what a successful inspection is for your company, you can ensure everyone is working together to meet those goals, which in turn, will increase the probability of having a successful inspection outcome.  At Enterey, in partnership with Mark Tucker, LLC, we can help you in all aspects of inspection management to help ensure you meet your inspection outcome goals.

Comments?  Questions?  We want to hear from you.


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Published by Mark Tucker | Inspection Management & Auditing Expert, Enterey and Mark Tucker, LLC

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Tags: Enterey, FDA, Inspection Management, Inspection Readiness, Inspection Management Systems, Mark Tucker, Enterey News, Drug Manufacturers, Life Sciences Industry News Life Sciences News & H, Communication, Pharma, PAI, Pre-approval Inspections