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...

The FDA’s “Dos” and “Don’ts” for responding to a 483.

Posted on November 13, 2013

DO! • Include photos where possible. • Include documentation to provide evidence that corrective actions have been implemented. • Pay particular attention to observations that are noted as being repeated from previous inspections. If you have not remediated a previous observation, it may be that you did not understand what the FDA meant. Ask!  If you had the observation at one site, but did not address it at all sites, you will need to make sure that you...

Complaint Files

Posted on September 11, 2013

Observations related to complaint file handling make up a significant portion of 483 findings and Warning Letter observations for Medical Devices. In the 483 data released by the FDA for 2012 Device inspections, out of 1090 issued 483s, there are over 400 observations for different sections of 21 CFR 820.198, the regulations dealing with complaint files.

Design Control

Posted on August 14, 2013

Out of 99 Warning Letters issued to Medical Device companies in 2013 (up to July 3rd, 2013), 50 have contained observations relating to Design Control  (21 CFR 820.30) deficiencies, with a total of 85 observations. The three subcategories that received the most attention are (f)Design Verification (12 observations, or 24% of the Medical Device related Warning Letters), (g) Design...

Out of 99 Warning Letters issued to Medical Device companies in 2013 (up to July 3rd, 2013), 50 have contained observations relating to Design Control  (21 CFR 820.30) deficiencies, with a total of 85 observations. The three subcategories that received the most attention are (f)Design Verification (12 observations, or 24% of the Medical Device related Warning Letters), (g) Design...

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....

Fast TrackWise Implementation

Posted on June 06, 2013

Autobahn™ means the fastest TrackWise® Validation on Earth. See how we do it.

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...