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May 2012


Andrew SnowWalt Murray

Process Verification vs. Process Validation

by Andrew Snow, Momentum Solutions, LLC and Walt Murray, MasterControl, Inc.

Process validation officially became part of the FDA's Quality Systems Regulation in 1997. Fifteen years later medical device manufacturers still struggle with determining which processes require validation. The confusion traces back to two words, "fully verified." What does "fully verified" mean? What do I do if I determine that process can't be "fully verified?" And, equally important, what are the FDA's expectations when I can't?

The answer to the "fully verify" question can have big consequences. Failure to identify a process that requires validation can cause compliance issues, including warning letters, delays in pre-market submissions and field actions. A conservative approach of validating everything can be costly. And worse yet, some people erroneously think that if they can fully verify something, the verification has to be 100%. This approach, unless automated, may be a statistically invalid approach because even manual 100% inspection is statistically not 100% effective.

The goals of this article are to clarify 1) how to determine if something can be fully verified, 2) how to plan validation and process control for those that can't be fully verified; and 3) how to monitor and control processes using a risk-based approach.

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Cindy Fazzi

Trends in Q1 FDA Warning Letters

by Cindy Fazzi
Marketing Communications Specialist, MasterControl, Inc.

If you work in the life science industry, it is always a good habit to periodically check the FDA's website for enforcement actions and warning letters. You can glean important insights from the mistakes and weaknesses of other companies in your industry, maybe even your competitors. You will see what the FDA is emphasizing in inspections, perhaps see some trends.

For the purpose of this article, that's what I did. Specifically, I checked how many warning letters related to CGMP and CGTP violations were sent to pharmaceutical, blood/biologics, and medical device companies in the first quarter of 2012. I counted 35 such warning letters.

With the help of a spreadsheet and lots of coffee, I reviewed the information available from the FDA website. I made a list of all 35 life science companies that received warning letters between January and March 2012 and identified their top five violations only. Some companies had only two or three violations; others had more than five.

I categorized violations by the regulation cited. In some instances, especially with pharmaceutical and blood/biologics companies, I combined related observations. For example, I combined 21 CFR 211.192 and 21 CFR 211.188 because the observations were all related to batch.

Out of the 35 warning letters, 23 were sent to medical device companies, nine to pharmaceutical, and three to blood/biologic companies.

The warning letters originated from the CDRH (11), CDER (eight), CBER (1), and also from FDA district offices in New Jersey (3), New York (1), Cincinnati (1), Philadelphia (2), New Orleans (2), Los Angeles (2), Atlanta (1), Kansas City (1), Minneapolis (1), and San Francisco (1).

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Did you know how BIZARRE medical advice and medical advertising have often been in the past? With medical device and pharmaceutical professionals working hard to make a positive difference, it's often interesting, and even outright hilarious, to take a look back at the medical advice/remedies of the past and to realize how far life science professionals have progressed.
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