We recently attended the CropLife America/Rise Spring Conference. In a session entitled EPA Good Laboratory Practices (GLP) – Supporting Credible Science, we learned that only 50% of the Product Chemistry Studies submitted were considered compliant with GLP.
In 2012 alone, 15 Product Chemistry Studies were actually rejected! It appears most likely that the primary reason for this issue is that often, sponsors may be inexperienced with Product Chemistry Studies and are using labs that do not have extensive experience with GLP compliance and/or OPPTS Product Chemistry Studies. There are several experienced labs, each with an excellent reputation in this area, but perhaps there are many more that are trying to do these studies without that depth of knowledge.
What should a sponsor look for in a partner to develop data for Product Chemistry Studies? Look for a successful history. It is also important to assure the laboratory you choose has an excellent quality and compliance team. You may also want to hire a consultant to help you through the process.
We would be interested to hear your ideas and experiences with Product Chemistry Studies.