Current Good Manufacturing Practice for Radiopharmaceutical Products (GMPR)

Good manufacturing practice for immunological veterinary medicinal products.

Good manufacturing practice (GMP) is applied to the manufacture of immunological veterinary medicinal products (IVMPs) in a number of regions around the world. Within the European Union (EU) there are well-established requirements for GMP in the manufacture of IVMPs. Maintaining GMP when producing IVMPs is important because there are particular risks associated with their manufacture. These ris...

Current good manufacturing practice for positron emission tomography drugs.

The Food and Drug Administration (FDA) is issuing regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs. The regulations are intended to ensure that PET drugs meet the requirements of the Federal Food, Drug, and Cosmetic Act (the act) regarding safety, identity, strength, quality, and purity. In this final rule, we are establishing CGMP regulatio...

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

The Food and Drug Administration (FDA or we) is proposing to amend our 2013 proposed rule for Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. In that 2013 proposed rule, we proposed to add CGMP requirements for animal food and to add requirements for certain domestic and foreign facilities to establish and implement hazard ...

Quality Assurance and Good Manufacturing Practice in Respect of Plasma Fractionation

DEMAND ESTIMATES FOR AGRICULTURAL, MANUFACTURING AND SERVICE PRODUCTS