Positron emission tomographic (PET) radiopharmaceutical preparations refer to radiopharmaceuticals containing positron-emitting radionuclides. They are generally prepared by medical institutions or radiopharmaceutical manufacturers before clinical use.

There are two main sources of positron-emitting radionuclides: cyclotron produced and generator produced. The Guidelines is only suitable for the quality control of the PET radiopharmaceutical preparations produced through cyclotron. The quality control of PET radiopharmaceutical preparations produced through generator should refer to Guidelines for the Quality Control of Technetium [99mTc] Radiopharmaceutical Preparations.

In order to ensure the safety and efficacy of PET radiopharmaceutical preparation administration. Quality control tests must be carried out for each batch of produced PET radiopharmaceutical preparations according to corresponding national standards. If there is no national standard for a PET radiopharmaceutical preparation, the acceptance criteria should be established by the manufacturer and then validated by the National Institute for the Food and Drug Control before put into practice.

The preparation and quality control of PET radiopharmaceuticals have the following characteristics.

(1) The physical half-life of radionuclides emitting positrons is generally very short, so the preparation of PET radiopharmaceuticals must be rapid. Generally, automatic synthesis systems are used to protect operators from excessive ionizing radiation.

(2) Generally, PET radiopharmaceuticals are prepared and synthesized by medical machinery before they come into use. Given that fluorine [18F] has a slightly longer half-life, radioactive drugs containing fluorine [18F] can be prepared and supplied by nearby qualified medical institutions or manufacturers.

(3) PET radiopharmaceuticals have small batches, each of which generally contains only a few doses.

(4) Quality control inspection shall be carried out fast.

Considering the characteristics of the preparation and quality control of PET radiopharmaceuticals, it is impossible to conduct a full inspection of each batch of the products before clinical use.

The Guidelines is formulated in accordance with the Drug Administration Law and the Administrative Measures of Radioactive Drugs in order to ensure the quality, safety, and effectiveness of PET radiopharmaceuticals and standardize the quality control.