High frequency of CAPA related observations in Warning Letters.

Posted on July 18, 2013

Globiox proactively monitors FDA inspection trends by reviewing and analyzing the contents of the Warning Letters. A current trend we detected is the high frequency of observations related to Corrective and Preventive Actions (CAPA) in Warning Letters. Out of 43 Warning Letters issued to Medical Device companies (since March 22, 2013), 29 have contained observations relating to Corrective and Preventive Actions (CAPA) deficiencies 21 CFR 820.100. Of these 29 Warning...

Don’t let the User Manual become the User

Posted on June 12, 2013

Over the years we have had many projects where users have asked us to qualify their laboratory equipment and validate commercial off-the-shelf (COTS) software. Sounds pretty straight forward, right? But when we look at the customer’s user requirements documents, we realized that they were derived from user manuals and specification sheets that manufacturers provide for that equipment. Some requirements even read like advertising lingo and performance claims from a website....

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The FDA has recently released a draft guidance entitled “Molecular Diagnostic Instruments with Combined Functions.”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The FDA has recently released a draft guidance entitled “Molecular Diagnostic Instruments with Combined Functions.”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...

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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Warning letters, what they are, how we can help

Posted on October 09, 2012

As discussed in our previous post, "FDA 483: your company contains critical errors," a company whose operations are not compliant with the regulations set out by the Federal Food, Drug, and Cosmetic Act and related acts (The Act) is likely to face serious consequences from the FDA. Although there are exceptions in the case of serious violations, a Warning Letter is generally issued by the FDA following an extensive review of site inspection results, usually within 30 days of the inspection close out. The purpose of a Warning Letter is to notify companies that they are operating in violation of The Act, and that they are expected to remedy all outstanding issues in order to become compliant. The significance of a Warning Letter versus a 483 is that a Warning Letter is an official statement by the FDA confirming that a company is operating out of compliance, whereas a 483 is an inspector’s (highly influential) opinion on the matter, but is not an official Agency...

FDA 483: Does your business contain critical errors?

Posted on August 22, 2012

In the aftermath of an FDA site inspection resulting in unsatisfactory findings, the company in question faces a difficult situation that must be addressed quickly to avoid serious consequences. If not properly addressed, negative observations made during an FDA visit can ultimately result in suspended operations, bad press, scrupulous monitoring of operations, recall of products, and warning letters. Fortunately, the process followed by the FDA is intended to allow most companies operating out of compliance to remediate their practices and continue operation in an acceptable manner. Although the remediation process tends to be hectic and unpleasant, it can actually be beneficial for a company because if done correctly, the remediation will result in higher quality business practices.

At the conclusion of an FDA site visit, the inspectors will issue an FDA Form 483 if there are observations. A 483 lists detailed observations of any issues the inspectors consider...