Method of production

A method for producing a packaged radiopharmaceutical drug product (e.g. a radioligand drug product) comprising the steps of:

• (1) Synthesizing and compounding a radiopharmaceutical drug substance solution in one or more shielded units of (cleanliness zoning requirement) Grade C to obtain a radiopharmaceutical drug product;
• (2) Providing primary packaging materials, e.g. by (outer-layer-)unpacking in one or more cold units of Grade C, sanitizing in one or more cold units of Grade B, and (inner-layer-)unpacking said packaging materials in one or more cold units of Grade A;
• (3) Filling the radiopharmaceutical drug substance solution obtained by step (1) into the primary packaging materials as provided and unpacked by step (2) in a shielded unit of Grade A to obtain the primarily packaged radiopharmaceutical drug product;
• (4) Inspecting the primarily packaged radiopharmaceutical drug product obtained by step (3) in one or more shielded units of Grade “Controlled, non-classified” (CNC);
• and
• (5) optionally, placing the primarily packaged radiopharmaceutical drug product as inspected by step (4) into a shielded secondary packaging material in one or more shielded units of Grade CNC to obtained a primarily and secondarily packaged radiopharmaceutical drug product.