EQUIPMENT VALIDATION IS NOT PROCESS VALIDATION

Posted on June 11, 2014

Frequently we get calls from medical device companies telling us that they need to validate their processes, either because a customer, a partner, the FDA, or another regulatory body has cited them during an audit for lack of process validation. In many of these situations, the statement of work presented to us includes IQ, OQ, and PQ for the equipment and product, but not validation of the process. Process validation cannot proceed without calibrated and qualified/validated...

Frequently we get calls from medical device companies telling us that they need to validate their processes, either because a customer, a partner, the FDA, or another regulatory body has cited them during an audit for lack of process validation. In many of these situations, the statement of work presented to us includes IQ, OQ, and PQ for the equipment and product, but not validation of the process. Process validation cannot proceed without calibrated and qualified/validated...

We do what we do for a reason

Posted on January 08, 2014

There was a talk given at a recent conference by a man named Rick Roberts, who has been a victim of both drug shortages and counterfeit drugs. Mr. Roberts grew up in small town in the US. Due to health problems, he had an inhaler from age one. Because of this, he had many trips to the pharmacy growing up and became very interested in the field, eventually deciding he wanted to be a pharmacist. Mr. Roberts went to college in San Francisco, California, and unfortunately contracted...

cGMP now includes Supply Chain Management

Posted on December 11, 2013

Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law on July 9, 2012 and addresses several areas, including the drug supply chain.

  • The FDA regulates products from more than 150 countries.
  • There are over 130,000 importers into the US, with over 300,000 foreign facilities providing these goods.
  • FDA regulated shipments at more than 300 US portshave quadrupled over ten years.
  • Finished drugs from overseas account for roughly 40% of Pharmaceuticals in the US
  • In 2008, approximatly 80% of Active Pharmaceutical Ingredients (APIs) were from foreign suppliers.

Under FDASIA the FDA will take different approaches. They may request extensive copies of records for review in lieu of actual site inspections. Products will be considered adulterated if they come from a company that has been found to be out of compliance at ANY location, not just the source of that...

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...

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...