Sampling and Samples. Bachem shall ensure that representative samples of Product are taken in accordance with GMP guidelines. Bachem will store API retention samples for all lots produced, sufficient to perform at least [***] full specification analyses, in containers that are equivalent to or more protective than the commercial packaging in accordance with the applicable GMP guidelines API samples will be retained for a minimum of [***] as of batch release. These retain samples will not be specific to Xeris. Xeris shall retain sufficient samples of Product for [***]. A quantity sufficient to perform [***] tests of Products shall be retained by Xeris.
Appears in 3 contracts
Sources: Quality Assurance Agreement, Quality Assurance Agreement (Xeris Pharmaceuticals Inc), Quality Assurance Agreement (Xeris Pharmaceuticals Inc)