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In This April 2015 Issue

Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling

On March 17, the FDA released the final guidance document titled "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."  The draft guidance was originally issued on May 2, 2011, and the FDA considered almost 500 comments before issuing the final guidance.   

 

The document focuses heavily on labeling content.  The guidance advises manufacturers to consider certain recommendations regarding human factors when developing reprocessing instructions and lists the following six criteria that should be addressed in the device's labeling:  (1) Labeling should address the intended use of the device; (2) the instructions should advise the users to thoroughly clean the device; (3) the instructions should indicate the appropriate microbicidal process for the device; (4) the instructions should be technically feasible and include only legally-marketed devices; (5) the instructions should be comprehensive; and (6) the instructions should be understandable.  The guidance also states that premarket submissions need to contain adequate labeling describing reprocessing instructions.

 

The guidance also provides recommendations for manufacturers to follow when validating their device reprocessing methods, and instructs that manufacturers should consider designs that will facilitate effective reprocessing at the earliest stages in the design process.  Please contact Matt Daly for more information on this topic.

A Few Thoughts on Quality and Compliance

W. Edwards Deming said "Quality begins with the intent, which is fixed by management" and "Quality is everyone's responsibility." Every Quality Manager who takes an entry level "Quality 101" class learns about Deming's philosophies as one of the "Grandfathers of Quality".

Joseph Juran said "..every successful quality revolution has included the participation of upper management. We know of no exceptions." His handbooks are well-known and utilized widely by quality practitioners still to this day. .

Phillip Crosby said "Quality is Free".... meaning (loosely translated) that it will cost your company money if you have to perform rework or provide replacements for quality-related problems.  General Motors, Chrysler, Motorola, Xerox and many hospitals benefitted from his concept of "Zero Defects."   

 

Deming, Juran, Crosby, and some of the other early/mid 20th Century gurus didn't have ISO standards, consensus standards, or ERP systems back then to help with their processes.  However they generally said the same sort of logical, business savvy things that the current 21st Century quality standards do when you examine them closely.

It has often been said that a "quality system" is a bit of a misnomer - - actually, a good "quality system" is a well orchestrated set of business practices, policies, and principles. Delivering them consistently in an FDA regulated environment gets you to the satisfying point of operating "in compliance". Operating in compliance keeps you in good graces with regulators, and should allow you to deliver product with a low cost of quality.

In our opinion, quality and compliance go hand in hand, and are essentially flip sides of the same coin.  In many larger companies, "Quality" and "Compliance are often treated as "Business Departments", or perhaps "operating disciplines". It might take work to fulfill both paradigms simultaneously, but it is possible.   Compliance with FDA and global regulatory requirements require an instilled quality worldview, some well planned business systems, and the continuous ability to fulfill your clients' needs consistently and fully. It's really just that simple. If we were to put on a quality guru hat to further clarify the general tenets of quality for business in the 21st century, it would read something like this:
  1. Think about what you're doing. 
  2. Plan it all out.
  3. Write it all down.
  4. Deliver what you plan.
  5. Take action when bad things happen. Sometimes, life doesn't go according to the best plans.
  6. Behave like the Hippocratic oath says and "do no harm." If there might be a "harm" - react immediately. Risk Management techniques help with the planning of and reaction to problems so that "do no harm" is a built-in mechanism.
  7. Listen when somebody has an issue, then go fix it.
  8. Be humble and be persistent. Your first try might be a little off the mark. Heinz 57 didn't work on the first 56 tries.
  9. Know your data. Measure whatever you can in your processes. This works for design, sales, marketing, Management Review, production, operations, and R&D.
  10. Document, Document, Document. Remember timeliness and presentation matter.
  11. Listen some more. Collect feedback. Check out your competition.
  12. Reflect. Revise. Reinvent if necessary.
  13. Treat your customers and suppliers like they want to be treated - and always be nice. Your workforce, your customers, your supply chain, and your regulators deserve it.
  14. An error in making "the right choice" can be a great downfall and cause repercussions that hurt you or your end user. Weigh the alternatives when you are faced with a tough call, and choose wisely.
If you miss the mark on any of those objectives, in all likelihood, you may miss your target on quality and operations goals.  If you miss on a few, including timeliness and documentation lapses, there might be an FDA 483 or a list of ISO nonconformance observations issued at your next inspection.  

The general concepts here are what good Quality process is built on, and could be used as a framework for executing a Quality Management System (QMS). How well does your QMS fit that framework? Is it time to revisit your quality goals for 2015?  

Perspectives on 503B Outsourcing Facilities

F ollowing the fatal fungal meningitis outbreak in 2012 that was traced back to New England Compounding Center (NECC) in Massachusetts, the FDA has significantly increased its monitoring and enforcement actions over the Compounding Pharmacy industry. In July of 2014 the FDA issued a Final Guidance on section 503A of the FD&C Act to clearly define what compounding pharmacy activities will be exempt from the full CGMP requirements of pharmaceutical manufacturing. At the same time FDA released a Draft Guidance for section 503B of the FD&C Act, for Human Drug Compounding Outsourcing Facilities.

The draft guidance for 503B Outsourcing Facilities garnered a significant response from Outsourcing Pharmacies, large and small, and other interested parties. A Final Guidance has yet to be announced but is expected later this year.

We have spoken and met with a number of Outsourcing Pharmacies since the draft guidance was published. There are many challenges ahead as organizations struggle to revise procedures and practices, and consider modifications to facilities, to come into compliance with the new regulatory reality. Some changes are relatively simple to implement; e.g. documenting inspection of received materials and review of certificates of analysis / compliance (COA / COC). Other changes may require significant investment of time and capital; e.g. where facilities may need to be upgraded to provide an ISO 7 environment around the ISO 5 clean work zone. Another major challenges for most, will be the increased expectations for Environmental Monitoring and Release Testing, both of which have the potential to significantly increase costs of operation.

Moving forward, it will be extremely important for Outsourcing Facilities to identify and understand their compliance gaps. The best tool to accomplish this is an audit by an independent party familiar with the pharmaceutical CGMPs and FDA enforcement of those CGMPs.

A Word From Our Staff

A good product release requires much planning, strategic thought, focused time management, teamwork, and concerted effort to focus on what the customer really needs.  A top quality product launch requires all of the above, plus the overwhelming desire to achieve amazement and delight in the eyes of the end user.

 

The "WOW!" factor is often the difference between "good" and truly "great"!  Achieving "WOW" in a service or product today is hard, but possible. It may take a little more effort at the start, but that's the whole idea of "building quality in."

 

Quality Management philosophies and ISO-based Quality Systems encourage you to design quality into your product and to continually improve. Operating your company in a state of regulatory compliance is the desired first step. Then, the regular use of quality tools, management reflection, and good common business sense moves you towards increasing levels of overall performance.  

 

When your company hits that "WOW!" level of function, you KNOW it. Your employees FEEL it. Your clients say "WOW! - I want more!" Your customers and your employees are happy, and Monday morning is not a dreaded work day.     

 

We know you want that "WOW" from your clients.  We can help you get there, and we just can't wait to get started. Ask us today how we can help at contactus@protocollink.com


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