Friday, September 01, 2006

Importance of Quality From Start to Finish

I was looking around the FDA site today for some information and ran across some items regarding product recalls due to quality issues (as opposed to safety and efficacy issues you’d see in the clinic). I found the CDER Report to the Nation 2005 – Improving Public Health Through Drugs that had some surprising information.

It takes a lot to make the drug chemical entity, get it into a formulation (tablet, capsule, liquid, etc.), and package it to get to the consumer. There are lots of scientists and engineers involved in getting raw materials, manufacturing a drug and then the formulation, testing along the way, and packaging. It takes a lot of effort to convince the FDA a process is in control and functioning properly to make the desired product. That’s expensive! It’s hard work to get a quality product out the door that is safe, stable, and working as advertised. With all the high powered science required, it’s not surprising that something unexpected might go wrong and as a result a product will have to be recalled.

What was surprising is that 3 of the top 10 reasons products were recalled in 2005 involved rather silly mistakes and not failures in what I would consider the science associated with manufacturing. They were:

  • Label error on declared strength
  • Promotional literature with unbranded claims
  • Correctly labeled product in incorrect carton or package

These mix-ups in labeling, packaging, or including the wrong literature must have cost a huge amount of money – even though the product itself was made correctly and of good quality. They didn’t give a percentage associated with these reasons in the recall section, but another chart in the report cited labeling issues in 14% of findings. Correcting these simple mistakes would have a big impact on the manufacturing cost for a product.

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