I have just received an interesting letter from Charles Rivers Edinburgh and there are a few interesting points I wanted to share with you.

“Since 2004, there has been a clear requirement to manufacture the IP (drug product) to Good Manufacturing Practice (GMP), however the quality standard required for the radiolabeled Active Pharmaceutical Ingredient (API) was open to interpretation. Following the implementation of GMP Annex 20 on Quality Risk Management in March 2008, and with the amendment to GMP Part II (Basic Requirements for APIs used as Starting Materials) in draft, a risk management approach to the assessment of the quality of the API has been adopted”

So if you wish to use radiolabeled products for human PK it does not necessary need to be GMP stock, this is a great and important point and can be truly valuable to companies planning risk management microdosing studies, but it does need to be assessed for potential risks. its an important point that needs considering.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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