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Good Manufacturing Practice for Investigational Pharmaceutical Products in Japan

Good manufacturing practice (GMP) is essential in the manufacturing of pharmaceuticals used in the investigational stage as well as in the manufacturing of commercial products. GMP at the investigational new drug (IND) stage is now being studied by government and industry. Several characteristics inherent to the manufacturing of pharmaceuticals used for clinical trials should be taken into consideration and focused on in establishing the IND GMP: 1. change control, 2. cleanliness of facilities and equipment, 3. validation for general processes, 4. record-keeping and documentation, and 5. labeling control. Those focal points are changed according to the clinical trial stage. Therefore, they should also be considered from the viewpoint of the stage of clinical trials: Phase I, II, and III. IND GMP would be well established and implemented by focusing on these characteristics.