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| Overview | Regulatory Strategic Solution | Biopharmaceutical Product CMC | Clinical Trial Service | PET Drugs | Pharmaceutical Product Solutions | Medical Devices & Supplies | ||
| Services: PET Drugs
PET is a medical imaging modality that requires the use of a unique type of radiopharmaceutical drug. Most PET drugs are designed for parenteral administration and produced by aseptic processing. Current Status of Japanese CGMP (J-CGMP) Japan's Ministry of Health, Labor and Welfare revised the old GMP for investigational drugs on July 9, 2009 to meet international standards for developing PET drugs before regulatory approval. The revised J-CGMP is the minimum standard for quality production of PET drugs at all types of PET drug production facilities (e.g. hospitals, institutions, radiopharmaceutical companies, etc.), considering the short half-life of radionuclide and the complexity in a PET drug production facility. Two definitions of i) verification and ii) qualification for PET drug production were added to the J-CGMP to ensure that facilities follow proper quality assurance and quality equipment/production procedures for PET drugs. PET drug facilities shall have the following functions: i) Verification To self-audit the procedures, specifications, processes, and materials by reviewing each lot of incoming materials before use; reviewing the restricted production batch/lot; checking laboratory control records for accuracy; and conforming with established SOP, protocol, and specifications before authorizing the final release. ii) Quality Control To review the PET drug production facility by checking for the appropriate equipment and written documentation (SOP, etc.), and to document the review result. In addition, J-CGMP allows PET drug producers to use vendors to manufacture their PET drug as an investigational drug outside of Japan. A Resource for Hospitals, Institutions, and Radiopharmaceutical Companies Pharma Training, Inc. will consult with you to meet J-CGMP standards for your PET drug production in conformity with J-CGC and referring to FDA Guidance/PET Drug CGMP (PDF, 400k) and USP more practically, concretely, and specifically. Our mission is to provide PET drug producers outside of Japan the opportunity to bring their business into the Japanese market by supporting the J-CGMP conformity process from the clinical trial preparation stage to regulatory approval in Japan based on global standards. |
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