Tentative translation of MHLW MO 169 revised in 2021, Chapter 5 (Note) 1) This English document is only for reference purpose. In case of any discrepancy, the Japanese text shall prevail. 2) The requirements of MHLW MO 169 are applied to both the Marketing Authorization Holder and the person operating the Registered Manufacturing Site. In this document the requirements are stipulated as the requirements for the Marketing Authorization Holder. Meanwhile, when they are applied to the Registered Manufacturing Site, the requirements must be paraphrased, as appropriate. Chapter 5. Manufacturing control and quality control of radioactive in vitro diagnostics (Infrastructure for operation at a registered manufacturing site of radioactive in vitro diagnostics) Article 80 Marketing authorization holders, etc. of products related to radioactive in vitro diagnostics shall meet the following requirements as an infrastructure for operation at a registered manufacturing site (excluding registered manufacturing sites where only design is performed; the same shall apply in this chapter) of the products (for a registered manufacturing site where only packaging, labeling, or storage of containers or wrappers specified in the proviso of Item 1, Paragraph 3, Article 2 of the Regulations for Manufacturing and Handling of Radiopharmaceuticals is conducted, provisions related to work rooms in E of Item 2 and D of Item 4 shall be excluded, and provisions related to testing rooms in E of Item 2 and D of Item 4 are excluded if such testing is conducted on its own responsibility by using other testing facilities of the registered manufacturing site or other testing institutions and if it is found that there is no problem). [1] It should be installed in a place where there is less risk of a landslide and flood. [2] Work areas for products related to radioactive in vitro diagnostics shall conform to the following requirements. A. They should be clearly separated from the other facilities. B. A main structure, etc. is fireproof or made of non-combustible materials (non-combustible materials specified in Item 9, Article 2 of the Building Standards Act [Act No. 201 of 1950]; the same shall apply hereinafter). C. Shielding walls or other shielding materials necessary to control the following doses at or below the dose limit specified by the Minister of Health, Labour and Welfare are installed. (1) Radiation dose to which people may be exposed in a place where people in a registered 1 / 6 manufacturing site always enter (2) Radiation dose at the boundary of a registered manufacturing site and in an area where people in a registered manufacturing site inhabit D. There shall be only one entrance/exit site, where people enter/leave on a routine basis. E. There should be work rooms and testing rooms (including animal testing rooms if animal testing is performed; the same shall apply hereinafter) conforming to the following requirements. (1) Internal walls, floors, and other parts that may be contaminated by radioactive substances (radioactive substances specified in Item 2, Article 1 of the Regulations for Manufacturing and Handling of Radiopharmaceuticals; the same shall apply hereinafter) shall have a structure with few gaps, such as protrusions, dents, and joint of finishing materials. (2) The surfaces of inner walls, floors, and other parts that may be contaminated by radioactive substances shall be flat and smooth and finished with materials that are difficult to be penetrated and corroded by gases or liquids. (3) There should be disposal containers that are free from risk of scattering, leaking, seepage, or flow of radioactive substances or those contaminated by radioactive substances and can be used for transportation and disposal safely. (4) A device, such as a hood and glove box, connected to exhaust facilities shall be provided to prevent the spread of air contaminated by gaseous radioactive substances or radioactive substances. F. There should be a contamination inspection room conforming to the following requirements (room for inspection and removal of contamination by radioactive substances on the surface of human body or objects worn on human body such as work clothes, shoes, and protective equipment; the same shall apply hereinafter). This does not apply to handling of radioactive substances in quantity or concentration at or below the levels specified by the Minister of Health, Labour and Welfare. (1) It is installed in the most approp