Thursday, September 22, 2011

Alkemy 101 Newsletter - September 2011

Why doesn't your HPLC
Method Work Right?
- The Method wasn't properly developed or qualified

- The "Reference Standard" wasn't really a standard at all

- The analytical data was inaccurately interpreted

- Wait! The method does work....the raw materials were switched without being properly qualified, etc.

There are numerous reasons why an HPLC method might not work for your product, but are you getting the run around as to what the real reasons are, and more importantly what the right solution is? Moreover, how can you identify the right solution for the least amount of money?

A strategic understanding of the appropriateness of method qualification should be considered fundamental to any Quality System. All too often, we are engaged in last minute troubleshooting for customers who had little or no early enough investment into the quality management of their products from an analytical perspective. Often, the mindset remains on finding a quick and dirty formulation followed by aggressive marketing of such products without qualifying the supply chain properly or ensuring analytical methods are in place. The resulting production delays, development fees and other costs relating to release testing, cGMP compliance and lastly mitigation of FTC or civil litigation can scale up to be insurmountable and cost-prohibitive in a very short period of time, if critical steps were not taken in the beginning.

For more information on how to qualify an HPLC method or to determine if method development is required for your product, give us a call today!