Monday, September 26, 2011

PDA FDA - Interesting Manufacturer Statistics

At the recent international PDA/FDA meeting, some very interesting statistics were shared. Drug products are manufactured in over 130 countries. In those 130 countries, there are over 300,000 manufacturers. Those manufacturers work through 130,000 importers. It is no surprise that the FDA requires drug manufacturers to audit suppliers and assure that the plant shown is the plant that will manufacturer the drug product. The FDA wants to make sure that there are no "shadow plants" being operated out of CGMP compliance.

To learn more about current GMP rules, visit our website:
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Thursday, September 22, 2011

Ready For Drug Pedigree Rules?

I recently attended a conference that included representatives from the European, Asian, and U.S. regulatory agencies. At that meeting there was much discussion around pedigree rules.

Some of the concerns expressed begin with importing drugs and bulk actives (now called active pharmaceutical ingredients (APIs)). At this level, manufacturers are required to qualify supplies. This means that a manufacturer must actually visit the API manufacturing site to assure themselves, and the public, that the production facility shown to the auditor is the actual site of manufacture, and that there is no "shadow site" where the real work takes place.

Internationally, there are different approaches to the pedigree. In Europe there is exploration with a "book ends" approach. This approach requires the manufacturer to issue the initial pedigree. The next pedigree touchpoint is at the pharmacy when the product is dispensed to the patient. The thinking is that if the product is moving between known distribution channels, then the product is protected. The U.S. requirement is to document every change in ownership. This means that every touchpoint is documented. Yes, regulators in Europe realize that this approach probably provides better assurance of the supply chain. However, they are also concerned about how much work to pass on to the smaller distributors who may not be staffed for this level of documentation.

Learn more about e-Pedigree in our online computer-based training (CBT) courses:

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Monday, September 19, 2011

Online GMP Training - 21 CFR 820: Essential Elements

An example of the stent used in an EVAR procedureImage via WikipediaTake this online CBT (computer based training) if you need to review the 21 CFR 820 regulations from the perspective of being inside a medical device manufacturing facility. Learn the rules affecting medical device manufacturing, while getting a glimpse of medical device production techniques.
This class is appropriate for all employees of medical device manufacturing organizations. Upon the completion of the class, employees will be able to summarize the 15 subparts.

Online computer-based training (CBT) is the way to complete required training at minimal cost.

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Monday, September 12, 2011

FL Certified Designated Representative - Use The Most Current CIB

An enlargeable map of the 67 counties of the S...Image via WikipediaFL CDR - Caution - Use the most current CIB | Designated Representative and Exemptee: 'via Blog this'

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6/29/2012 update.

CAUTION - there are old versions of the candidate information booklet (CIB) that can be found on the internet. Be sure you're referencing the most current version. The most current version, as of today, is the June 2012 edition. Here's how I found it.

Go to the home page of the Florida Department of Business and Professional Regulation:  http://www.myflorida.com/dbpr

In the search box, enter "CDR CIB"   In the search results, click on "Candidate Information" and there you have it!

For your quick reference, here's the June 2012 CDR CIB:  http://www.myfloridalicense.com/dbpr/servop/testing/documents/CDR.CIB.pdf
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We continue to see two versions of the Florida Certified Designated Representative (CDR) Candidate Information Booklet (CIB) out on the internet.

Make sure you are looking at the most current version of the CIB. There's an older October 2010 version floating around. At the time of this post, there's a more current version, March 2011 that's been published.

Reference:
CANDIDATE INFORMATION BOOKLET for the Florida CERTIFIED DESIGNATED REPRESENTATIVE LAWS AND RULES EXAMINATION COMPUTER BASED TEST (CBT) MARCH 2011

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Monday, September 5, 2011

e-Pedigree - CA Board of Pharmacy

We'll be attending the Sept 7th CA Board of Pharmacy meeting, where one of the agenda items is e-Pedigree ...




Updated 12/6/2011:
The minutes finally got posted. You can find them here, and they include:
Discussion on the Implementation of California’s Electronic Pedigree Requirements for Prescription Drug

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