How Does Your Organization Define it?
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:
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