Author: Nigel J Smart PhD

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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Strategy for FDA Inspection Process; Part 5

……being well prepared is the most effective strategy for success! As previously mentioned, eradicating entry points or exposure points for selected data and information will play a major part in your strategy for a successful FDA inspection. The agency is looking to test your quality management system to see if it proves effective in helping your site to remain in compliance. Immediate in that inspection strategy is to define exposure points, or points of weakness which then can be used to rigorously evaluate how well you are doing. In the first instance then they’re looking to build a high-level...

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Delivering Success in an FDA Inspection Process – Part 4

—-Be prepared, the FDA cometh! Preparing for the FDA is key and underpinning for success in navigating the inspection process. Most important is to pick the right core team to help prepare the site for the process. After the fact, this team can also be helpful in maintaining processes so that things are always in a good state of readiness. This can prove to be a welcome bonus! Important is to make sure that the team and its members are clear in terms of their responsibilities. In preparing a good strategy,it is to important to spend a budgeted amount...

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