Combined Use Diagnostic Instruments, and the FDA’s Thoughts

Posted on May 15, 2013

The FDA has recently released a draft guidance entitled “Molecular Diagnostic Instruments with Combined Functions.” The recommendations display intent to mitigate interference in molecular diagnostic instruments with combined FDA approved device functions and functions in which FDA approval is not required, and furthermore prevent confusion for the end user. While following the guideline should serve to minimize interference, adherence to certain recommendations will...

The FDA has recently released a draft guidance entitled “Molecular Diagnostic Instruments with Combined Functions.” The recommendations display intent to mitigate interference in molecular diagnostic instruments with combined FDA approved device functions and functions in which FDA approval is not required, and furthermore prevent confusion for the end user. While following the guideline should serve to minimize interference, adherence to certain recommendations will...

What Happens When You Can’t Test a Test?

Posted on April 16, 2013

Test Method Validation (TMV) is a critical part of ensuring quality for manufacturing. This highly specific aspect of validation involves proving that quality testing procedures for a manufacturing process consistently provide accurate results. When a TMV fails, specific steps must be taken, in the proper order, to ensure the best remediation and damage control possible.

The first order of business is to thoroughly examine the reasoning behind the Test Method. Why is it...

Do you “like” your friends?

Posted on March 13, 2013

Many of us have a Facebook page and we use it to comment and “like” comments with little thought of how those actions may be viewed. Regulated companies may need to rethink this, as “likes” could be considered as public restatements of an opinion. We read a lot of Warning Letters at Globiox, and one such letter received a lot of interest recently because of one section regarding a company’s actions on Facebook.

We also note claims made on...

GLP vs. GMP

Posted on February 20, 2013

What is Good Laboratory Practice (GLP), and what is Good Manufacturing Practice (GMP)? If you work in the pharmaceutical industry, chances are you have heard these terms before, and have at least a general idea of what they entail: tightly controlled processes, stringent records, focused training, constant analysis, and detailed auditing. Surprisingly, the issues arising from GLP and GMP often stem from a misconception of which quality system standard applies to certain situations. The causes of such confusion can be insufficient scoping activities, misinterpretation of regulatory literature, misguided advice from an outside source, or a sponsor’s demands regarding a particular study.

The confusion surrounding GLP vs. GMP is understandable; after all, since the middle word in GLP is Laboratory, it should apply to anything done in a lab, right? And the same for GMP; Manufacturing practices should only apply to manufacturing lines, right? Unfortunately,...

Change Control

Posted on January 09, 2013

In our last post, we talked about the importance of keeping business operations current with FDA regulations, and how this has to be constantly monitored in order to prevent gaps between the two. What we didn't cover is the way in which changes need to be made. The process is referred to as change control, and proper execution is of vital importance. Keep in mind that this discussion pertains to validated systems; any system that should be validated and has not been validated cannot be considered compliant.

Change control consists of the methods by which proposed system changes are researched, tested, executed, and documented. By properly performing a change control to a validated system, you are showing that whatever you are doing differently works in conjunction with what was previously validated. Boiled down, a change control is really just a mini-validation. The difference is the scale of effort, which makes a huge difference in the cost; quite a few...

Keeping up with the FDA

Posted on December 11, 2012

Quite a few companies in FDA regulated industries are experiencing "Dynamic Shock." After handling their operations and quality assurance in the same manner for years, they are suddenly faced with severe findings on a 483, or are even issued a warning letter. Dynamic Shock stems from the constantly shifting nature of the industry and the practical policy changes the FDA makes, with the goal of constant industry improvement. These changes often take the form of industry guidances, which reflect the FDA's current mindset about various aspects of certain industries. Some guidances receive large amounts of attention in the media and are difficult to overlook. Others however, are less publicized and are missed by some companies, resulting in negative findings during an FDA site visit.

The FDA does make serious efforts to ensure that regulatory information is readily available to the public. Fda.gov contains a vast wealth of literature, including industry...

Validating the Cloud

Posted on November 14, 2012

As a sales guy, I am often speaking to Life Science professionals about the challenges they face. The subject that keeps coming up of late is the Cloud. There seems to be a lot of confusion, concerns and excitement about the possibilities that the Cloud presents for regulated industries. Our resident expert Leo Perskii received high praise when he presented on this very topic recently in San Diego. This 4 part series is now available and this month we are excited to share it with you.

Part 1: Leo explains the characteristics of Cloud Computing.  It’s a brief rundown of what the Cloud is and why the regulated industry should care.

Part 2: What should you consider when deciding if the Cloud is right for your company? This video is a great place to start.

Part 3: Once you have decided that the Cloud will work for you then how do you decide who to engage as your provider? There are questions you need to ask and things to consider.

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Part 4 Cloud Computing Issues and Their Influence on Validation

Posted on November 14, 2012

Part 1     Part  2     Part 3

Part 3 What to Know Before Engaging a Cloud Provider

Posted on November 14, 2012

Part 1     Part 2     Part 4

Part 2 Considering Whether to Use Cloud Computing

Posted on November 14, 2012

Part 1     Part 3     Part 4