As per the June 2013 draft guidance ANDAs: Stability Testing Drug Substances and Products, the FDA intends on using the ICH Stability Guidelines as a benchmark for ANDA and DMF Type II submissions. Initially this was set to take effect January 1, 2014. However, with the efforts of GPhA, the implementation has been postponed nearly six months to June 20, 2014.
A Quick Overview
So, how will this change affect your projects and how to best leverage this information before the ICH Guidelines are adopted?
as of June 20, 2014
|Finished Dosage||One Exhibit Batch for ANDA filing||Three pilot scale batches.
Two pilot scale batches
and one small scale batch.
|Finished Dosage||A three month Long Term stability sample for one Exhibit Batch.||Six month Long Term and Accelerated
stability data for three batches.
|Active Pharmaceutical Ingredient||A three month Long Term stability sample for one API lot.||Six month Long Term and Accelerated stability data for three API lots. A minimum of two lots of the drug substance should be used to prepare the three primary batches of drug product for ANDA application.|
Additional stability studies will translate into a need for additional resources – space, equipment, personnel, materials, etc. Bottom line – your stability testing costs are going to increase. Now is the time to:
- Move ahead on projects that have been temporarily put aside
- Accelerate development efforts of more expensive products.
How We Can Help
As a full service generic API development and supply company with over 30 years of experience, ChemWerth is your one stop shop – with you every step of the way from product selection to product launch. Our ability to navigate through the tough issues will help you submit your ANDAs before June 20th, so you can get to market faster.
In an effort to help identify and push projects forward, our sales team will be reaching out to you to discuss where to best focus efforts over the next 10 months.