Glossary
Good Manufacturing Practices
FDA regulations that assure the safety, identity, strength, quality and purity of cell, gene and drug products by requiring adequate control of manufacturing for these products.
Like all pharmaceuticals, cell and gene therapies must be produced under conditions that meet rigorous FDA standards before they can be tested in humans. These standards, known as Good Manufacturing Practices, or GMPs, require strict operational controls to ensure the identity, strength, quality and purity of drug and cell products.