Extractables and leachables (E&L) studies constitute a pivotal element of regulatory submissions aimed at validating product safety. The complexity of E&L investigations varies depending on the container-closure system and drug product under scrutiny. Selecting a Contract Research Organization (CRO) endowed with expertise is imperative for the meticulous generation of reliable E&L data. The ISO certification for contract research labs that conduct microbiology and analytical chemistry testing on pharmaceutical products is ISO/IEC 17025. This standard specifies the general requirements for the competence, impartiality, and consistent operation of laboratories. It applies to all organizations performing laboratory activities, regardless of the number of personnel or the extent of the scope of testing and/or calibration activities. Read More >