PDA TR 66

PDA TR 66 discusses single-use systems that are in either direct or indirect contact with raw materials, intermediates, and pharmaceutical drug substances or drug products and is intended to provide the reader with critical concepts or points to consider when implementing an single use system strategy in a pharmaceutical manufacturing process. These concepts are intended to be valid both for chemically synthesized small molecules and for bioprocesses that produce large-molecule biopharmaceutical products. The document does not intend to discuss disposable items related to laboratory activities, final delivery system to the patient, transfusion bags, packaging, or medical devices.