Analytical. o Draft release Specifications for API, raw materials, and bulk packaging components for Client approval. o Conduct API, raw material, and bulk packaging component release testing; execute API ID test method (HPLC) transfer protocol from Client. o Draft equipment procedure documents using Client supplied analytical method and equipment protocols and procedures for Client approval. o Conduct Sterility and Endotoxin (LAL) testing of the Product. o Supply Certificate of Testing for Sterility and Endotoxin testing of Product to Client. o Qualify Endotoxin (LAL) method on one (1) batch of AI-850.
Appears in 2 contracts
Sources: Development and Supply Agreement (Acusphere Inc), Development and Supply Agreement (Acusphere Inc)