Author: Nigel J Smart PhD

More on the Topic of FDA Inspections

So, what are some of the things that we need to do to get ready for the next FDA inspection?First of all, we need to get into the habit of holding practice sessions so that we can drill anything and everything that can come up in the inspection process. It’s a good idea to look at the historical review file that will have been recorded from the last few inspections as this will give you a good idea of some of the things that the agency has an appetite to look at. If we know of areas of weakness...

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FDA Readiness. Strategies and Tips for Success

The FDA will look for entry points into your Quality Management System as a mechanism to highlight potential issues. Some key examples of things that will be looked at which often provide willing entry points includes: Deviations and logbooks. Laboratory errors. Change Control records. These are all records and documents that provide a primary route into finding the things that are wrong with your system of manufacturing. From these records the investigator can drill down to discover further issues and problems by looking at the following. Investigations. CAPAs and whether they are closed out if effective. Training records. Maintenance...

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Supplier Audits and Maintaining Quality Compliance

With the ever-increasing complexity of pharmaceutical supply chains, as more and more companies outsource the manufacturing, the mechanism for assuring your suppliers are reliable and appropriate for your needs becomes more difficult. The recent burgeoning pandemic that is that Corona virus raises new issues about whether “all our eggs” should be in a certain basket! Supply chain management is nothing new, and supply chains involving multiple global sources has become the norm. New tools such as block chain (see our blog dated April 24, 2018), are also working their way into our business and potentially can provide new powerful...

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Manufacturing Supply from Asia. At what point does this put the US Healthcare consumer at risk?

As the Corona virus continues to take hold of the world, what is the potential for this to affect US healthcare? Clearly this could be affected in more ways than just infection rates as our dependence upon foreign drug manufacturing continues to expand.For several decades now, India has been a leader in supplying more and more of our pharmaceutical needs, especially generics, with over 40% coming from that region. Although pricing has been favorable for pharmaceutical companies in terms of their cost of goods, manufacturing quality has been experiencing its own crisis, with over 30 companies receiving FDA Warning...

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The FDA Inspection Process; Tips and strategy

The FDA is always looking for entry points into your documentation to highlight potential issues that you might have. Examples can include your deviations, so they’ll look at logbooks to see where your problems are. They’ll look at your change control logs and whether or not these are being appropriately reviewed and whether they’re being closed out. They’ll look at your investigations to see whether they’re being thoroughly thought through and whether they are using a risk management approach. They’ll look at what tools you’re using to elucidate root causes. CAPAs will be another key quality management element that...

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