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

3 Simple Steps for Successful Process Validation Gap Analysis

Posted by Tita Tavares on Wed, Mar 30, 2011 @ 11:43 AM


FDA: NEW Guidance for Industry
Process Validation: General Principles and Practices

FDA issued its final guidance on Process Validation (Revision 1) on January 24, 2011. This guidance replaces the 1993 guidance.


This guidance reflects FDA’s current thinking on the topic and outlines the general principles and approaches that FDA considers appropriate for process validation for the manufacture of human and animal drug and biological products, including finished products, APIs, and combination products, and collectively referred to as drugs or products in the guidance.


This guidance aligns process validation activities with the product lifecycle concept and with existing FDA guidance, including FDA / ICH guidances for industry Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. Although this guidance does not repeat the concepts and principles explained in these guidances, FDA encourages the use of these development concepts, QRM, and QS at all stages of the product and manufacturing process lifecycle.


FDA has the authority and responsibility to inspect and evaluate process validation performed by manufacturers. Process validation for drugs is a legally enforceable requirement under section 501(a)(2)(B) of the Act (21 U.S.C. 351(a)(2)(B). CGMP regulations for validating pharmaceutical manufacturing can be found in 21 CFR Parts 210 and 211.


Although FDA guidance documents are recommendations, pharmaceutical manufacturers are already assessing the scope of the new guidance and performing a gap analysis to initiate corrective action and remediate the gaps in their current standard operating procedures to enhance and align their process validation activities with FDA recommendations.


Successful Process Validation in 3 Steps

Step 1: read the FDA guidance for industry documents.

Step 2: complete a gap assessment.

Step 3: determine an action plan via CAPA to correct the gaps and maintain the changes to your
process validation activities and Quality System.

Published by: Jim Anthony, Enterey | Director 

Follow these steps and you’re on your way!
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Up next: Highlights in the new guidance document.

Tags: Corrective Action, FDA New Guidance for Industry, Process Validation, ICH Q8, ICH Q9, ICH Q10, Gap Analysis, Quality Risk Management, Pharmacautical Quality System, Steps to Successful Process Validation, CAPA