The Enterey Blog

PROACTIVE COMPLIANCE. How Does Your Organization Define it?

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

PROACTIVE COMPLIANCE
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.  

Inspection 

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

Agency Inspections Are on the Rise

Posted by Tita Tavares on Thu, Jan 19, 2012 @ 11:44 AM


Inspections by the FDA and foreign regulatory agencies have significantly increased since 2003 as manufacturing becomes more global and other countries regulate drug products. Between 2003 and 2005, the number of foreign inspections performed by the FDA ranged between 218 and 252. By 2007, that number had increased to over 450 per year and by 2009, it was up to nearly 550, dropping to 522 in 2010. In 2008, joint inspections began between regulatory agencies. That process continues today:

 Enterey Agency Inspection Rise

With the current leadership at the FDA stressing enforcement (as opposed to repeated warnings) for any violations or irregularities, 2010 saw the following actions:

  • 10 seizures
    (5 CFSAN, 3 CDER and 2 CDRH)
     

  • 17 injunctions
    (the highest rate since 2006)

     
  • 673 warning letters
    (171 CDER, 204 CDRH, 15 CBER & 191 CFSAN ).  This was the highest rate in warning letters since 2004.

     
  • 3,799 recall events
    (1,881 CBER, 258 CDER, 876 CDRH & 738 CFSAN) resulting in 868 different drug products being recalled from the market.

As demonstrated by the data collected by EFPIA, Agency inspections in Europe hit their high point in 2009, then began to level out somewhat. We believe this leveling is due to the major, worldwide regulatory agencies reaching their inspectional resources limits.  The FDA is still conducting the most inspections in Europe followed by the EU, then Brazil, South Korea, Japan and Mexico.  Of concern to us is the ever-growing number of inspectorates conducting “foreign” inspections.  And while China is not represented in the 2010 data, they are anticipated to become a major inspectorate in coming years.

 

As more and more countries begin implementing GMPs as a requirement for import, inspections of facilities in the US may continue to increase. However, Regulatory Agencies are also realizing that the number of manufacturing sites is growing faster, worldwide, than their resources available to perform inspections. We hope the number of inspections being performed will remain close to current levels.

Several factors make us think this will be true. For example, having the US FDA and other global inspectorates gain entrance to PIC/S will hopefully allow for better information-sharing between agencies, including inspection reports and resource sharing by inspectorates through joint inspections, one example being the recent EMA and FDA joint inspections which should reduce the number of on-site visits by Health Authorities.

 

At Enterey, in partnership with Mark Tucker, LLC, we can help you meet all your inspection management systems needs. This includes a system to help you self-identify and fully understand your compliance gaps; prioritize work and allocate resources to close those gaps; track gaps, actions taken and assess residual risk; fulfill the compliance requirements of ICH Q10; maintain an inspection-ready posture at all times; and respond to Agency findings systemically and quickly.

 

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Published by Mark Tucker | Partner of Enterey

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Tags: Enterey, FDA, Inspection Management, Mark Tucker, ICH Q10, Drug Manufacturers, EU

Why Inspection Management Systems Matter

Posted by Tita Tavares on Wed, Dec 28, 2011 @ 12:01 PM

There are many reasons why it is important for companies to develop and implement an effective inspection management system. In this blog, we’ll outline some of the reasons and how having an effective inspection system can benefit your bottom line.

Since FDA Commissioner Margaret A. Hamburg’s arrival in 2009, the FDA and other regulatory agencies have noticeably raised the bar on measures they are willing to take to protect patients’ safety. In her well-publicized speech of 2009 to the Food and Drug Law Institute entitled, "Effective Enforcement and Benefits to Public Health," Hamburg outlined measures being implemented to make the FDA stronger, more credible to the public, and more vigilant in their role of inspecting companies to ensure compliance. Her remarks included her desire for the Agency to take fast, effective actions when a company was non-compliant with the regulations.  As a result, the following actions have occurred at FDA:

  1. More Inspections: In 2011, more FDA inspectors were sent out in the field performing more inspections (particularly overseas).
     
  2. More/ Quicker Warning Letters: Companies no longer receive multiple warning letters like they did under previous administrations.  FDA is much more willing to take significant action after just one “poor” inspection.
     
  3. Elimination of Mandatory Legal Reviews: In doing so, the FDA has increased the speed of issuing warning letters while giving Districts more control over the tone and language of the letters.
     
  4. Post-Inspection Deadlines: Companies have 15 working days to respond to any problems that have been identified on the FDA 483 if they want to mitigate a possible Warning Letter.

 Why Inspection Management Gold

Increase in Consent Decrees: The FDA appears to be much more willing to use this Agency’s resource-intensive legal tool to get a company’s attention.  These actions are very expensive for both the Company and FDA; the willingness of the Agency to use this tool demonstrates their commitment to increase enforcement.

 

Willingness to Entertain Misdemeanor Prosecutions: At the 2010 FDLI Annual Conference, Eric Blumberg, FDA deputy chief for litigation in the Office of the Chief Counsel, heralded the reemergence of the Park Doctrine as part of FDA's new enforcement efforts. The Park doctrine allows the government to seek misdemeanor convictions against company officials for alleged violations of the FDCA – even if the officials were unaware of the violations – if they were in positions of authority to prevent or correct violations and did not.

 

A Good IMS Equals Good Business:

Implementing an inspection management system on an ongoing basis, 24/7, 365 days a year is just good business.  A well-functioning inspection management system is really a “work prioritization and resource allocation” tool designed to allow you to remain current in your compliance with appropriate laws and regulations.  With the multitude of areas that require maintenance, an effective system will help you rank your risks by criticality so that you can address your most urgent weaknesses and continually eliminate problems and issues.

 

A good IMS System:

  1. Allows you to self-identify and fully understand your compliance gaps.
  2. Allows you to prioritize work and allocate resources to close those gaps.
  3. Allows you to track gaps, actions taken, and assess residual risk.
  4. Helps fulfill the compliance requirements of ICH Q10 by helping to keep senior management informed about your state of compliance.
  5. Maintains an inspection-ready posture at all times so when the FDA inspector arrives unannounced, you are ready.
  6. Allows you to respond to Agency findings systemically and quickly.

 

Enterey, in partnership with Mark Tucker, LLC, offers a customized approach to help companies develop and implement an inspection management system that will help you meet these criteria. We will talk to you about what you have and need. Then, depending on your needs, we will help you develop an appropriate system and train your staff on implementation. Our training will allow you the ability to implement your new system, so that you can seamlessly interact with the Agency during and after an inspection.

 

What if a “Bad” Inspection Takes Place?

In the event of a bad inspection, we can help you prepare your response; including helping you understand if and where your inspection system failed.  Ultimately, your goal is to eliminate all gaps. If you invest upfront in preventative maintenance of your Quality system, you may avoid large expenditures on emergencies or reacting to regulatory agencies as you eliminate sources of error.   And when a significant issue does arise, you will be knowledgeable about the issue and able to present it to the FDA knowing you have done a good, documented investigation.  

 

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Published by Mark Tucker | Partner of Enterey

 

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Agency Inspections are on the Rise.

Tags: Enterey, FDA, 483 FDA Warning Letter, Inspection Management, Inspection Readiness, Inspection Management Systems, IMS, Mark Tucker