FDA Issues Final Guidance Regarding cGMPs for PET Drugs

September 20, 2011 By Steven Perez

FDA issued a final guidance in early August regarding cGMPs for positron emission tomography (PET) drugs. The document covers resources, procedures, and documentation for PET drug-production facilities. The 1997 Food and Drug Administration Modernization Act called for these cGMPs to be established, and they are now part of 21 CFR Part 212. This guidance complements those requirements by providing information for small entities working on these drugs, such as academic and nonprofit facilities.

ISO/IEC 17025 is a company level accreditation based on a standard published by the International Organization for Standardization (ISO) titled “General requirements for the competence of testing and calibration laboratories”. ISO/IEC 17025 is a general umbrella term used to refer to the specific standard; the current version of this standard is ISO/IEC 17025:2017. The standard contains two main sections: management requirements (primarily related to the operation and effectiveness of the quality management system within the laboratory) and technical requirements (primarily related to the competence of staff and calibration of equipment). The standard also gives requirements related to quality management such as document control and corrective action. This standard is the basis for accreditation from an accrediting body.

ADPEN has also been inspected by the US-EPA and US-FDA multiple times with no observations.

FDA Issues Final Guidance Regarding cGMPs for PET Drugs

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