Tag: fda

Mylan gets a 32 page 483

The FDA’s April 483 for Mylan Pharmaceuticals has been in the fore-front of a lot of conversations in the last week. Let’s be honest, the FDA posts a 32 page, 13 observation 483 report on any manufacturer and it will be news. One as prominent as Mylan and doubly so. On the same day, the FDA also posted a 2016 483 and 2017 warning letter against a Mylan facility in India.

The 483 is a hit parade of observations, like the 1st observation of failure of the quality unit, including a reference to lack of quality approval of change controls.

What everyone has been intensely focusing on is the strong emphasis on cleaning, with 11 pages dedicated to failures in cleaning validation.

Which to be frank, is a big deal in a multi-product facility.

Read the 483, and when doing so evaluate your site’s cleaning program. Ask yourself some of these questions:

  • Are there appropriate cleaning procedures in place for all products-contact equipment, product contact accessories?
  • Are there appropriate cleaning procedures in place for facility cleaning (dispensing, sampling room…)?
  • Do your procedures include the sequence of the cleaning activities? Is it significantly detailed?
  • Do the procedures address the different scenarios (cleaning between different batches of the same product, cleaning between products changes, holding time before and after cleaning…)?
  • Do the procedures address who is responsible for performing the cleaning?
  • Does the validation study, the acceptance criteria and when revalidation justification and keys documentation approved by Quality? Does it include a clear status on the cleaning process?
  • Is the strategy used for the cleaning validation clearly established? (matrix approach, dedicated equipment, worst case scenario, grouping equipment, equipment train…)
  • Are batches that come after the cleaning validation run, released after completion of the cleaning validation?
  • Are the acceptance criteria (products, detergents, cleaning agent, micro… ) scientifically established and followed? Do these acceptance criteria include a safety margin?

Approval of cleaning validation is a key responsibility of the quality unit that involves some very specific requirements. These requirements should be built into the quality systems, including validation, deviation, and change management.

FDA Repays Industry by Rushing Risky Drugs to Market — ProPublica

As pharma companies underwrite three-fourths of the FDA’s budget for scientific reviews, the agency is increasingly fast-tracking expensive drugs with…
— Read on www.propublica.org/article/fda-repays-industry-by-rushing-risky-drugs-to-market

This is worth reading. I remember when I first started it was easier to get European approvals before US, and have been surprised by the switch over the last few years.

I also watch all these companies struggle with QbD and wonder if these two trends go hand in hand.

No answers from me, but I do recommend reading this article.

Quality Metrics – Not Dead yet

Pink Sheet has an update this week on the FDA’s Quality Metrics initiative – US FDA Quality Metrics Initiative Continues Moving Forward … Quietly.

This is behind a firewall so may not be viewable by all.

The major takeaways were:

  1. The initiative is still happening
  2. the FDA wants to remind companies why they are doing this in the first place
  3. They are starting a pilot real “soon” now

These metrics have been a hard sell within Pharma. I’ll be curious what steps the FDA will be taking to rebrand the effort.