Global Drug Supply - Counterfeit Drug Debate Heats Up

One would think that it should be fairly straightforward to drive fake and counterfeit drugs out of the global drug supply chain. It turns out there are polarized viewpoints and specific interests by many involved, as reported by SecuringPharma, Counterfeit drug debate heats up at World Health Assembly.

The situation boils down to, some:

". . . countries disagree with the WHO's working definition of the term 'counterfeit', which they maintain is being confused with intellectual property rights (IPR) issues, preferring instead terms such as 'falsely labelled', 'spurious' and 'substandard'."

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FDA Says - Unwise To Ignore Form 483

I've taken for granted that no one would intentionally want to ignore an FDA Form 483. But just in case you thought about it, you'll want to reconsider. Read this Outsourcing-Pharma post, "Ignore a form 483? Not wise say FDA." Bottomline, doing nothing increases the likelihood of receiving a warning letter. In summary the FDA believes that “a well-reasoned, complete, and timely 483 response is in your best interest”. 

Related Posts: Medical Device Sponsors - FDA Trends and Tips To Avoid 483s More FDA 483 Resources - Comments and Pearls from Validation Online FDA 483 Inspectional Observations - learn from these examples 

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More FDA 483 Resources - Comments and Pearls from Validation Online

Check this out. More resources on how to apply learnings gleaned from FDA 483s. This particular resource can be found on the Validation-Online.net website. In particular, there's a nice collection of "cGMP FDA 483 COMMENTS." Here you'll find over 100 FDA 483 topics that cover a 483 issue with associated comments, tips, and recommendations. Validation Online says, "Some of the problems listed below cost companies million of dollars to find and rectify."

Previous FDA 483 Posts:
The Health, Drug, Prescription, and GMP Supersite: FDA 483 Inspectional Observations - learn from these examples

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FDA 483 Inspectional Observations - learn from these examples

• FDA cGMP QSR GMP Online Training - respected cGMP online training classes offered by SkillsPlus International Inc.

Here's a small collection of 483s (FDA Form 483 Inspectional Observations). If you've never seen one before, here's your chance. Take advantage of these to learn and share, so that you can avoid getting your own 483s. You can view these on the FDA's website, in the FDA Office of Regulatory Affairs (ORA) Electronic Reading Room. They display copies of ORA records. ORA makes these records publicly available either (1) proactively at their discretion or (2) because they are "frequently requested" per the Electronic Freedom of Information Act Amendments of 1996. Some records may be redacted to remove non-public information.

According to GMP Trends Inc., "an FDA 483 is a form used by an FDA investigator following an inspection of your plant. It lists deficiencies in your quality system and potential non-compliance issues with GMP's. These observations are based on the investigators interpretation of the GMP regulations as they apply to your specific situation. During the investigator's closing meeting with management, you may be given a Form 483." You can learn more about the FDA's thinking on 483s by reading this section from one of their manuals, FDA Investigations Manual - Reports of Observations.

These 483s can do several things for you. They'll:

1. Get you more familiar with what a 483 is all about
2. Give you the willies so you'll never want to earn your own 483s
3. Provide examples that you can incorporate into your GMP training efforts

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