VALIDITY CONFIRMATION METHOD FOR MANUFACTURING IN ACCORDANCE WITH STANDARD/LEGISLATION/GUIDELINE, WHICH IS ONE OF STANDARD, LEGISLATION, OR GUIDELINE DETERMINED IN ADVANCE FOR TARGET FACILITY, WHICH IS ONE OF EQUIPMENT FOR PRODUCING PHARMACEUTICALS OR QUASI-DRUGS, EQUIPMENT FOR MANUFACTURING MEDICAL DEVICES USED IN PERFORMING OPERATIONS ON PATIENTS, OR EQUIPMENT FOR PRODUCING ONE OF THOSE THAT HAVE BEEN PROCESSED INTO CELLS OR THAT HAVE BEEN INTRODUCED INTO LIVING CELLS AND THAT CONTAIN GENES THAT ARE EXPRESSED WITHIN BODY

摘要

To provide a validation confirmation method for manufacturing in accordance with one of standard, legislation, or guideline determined in advance for target equipment.SOLUTION: Instead of a conventional validation confirmation method, the proposed method includes specifying target equipment during manufacturing as N sets of production units connected to each other at a connection section, preparing a building that forms a storage space capable of accommodating the N sets of production units, confirming the validity for manufacturing in accordance with one of standard, legislation, or guideline determined in advance for a target production unit, and confirming the validity for manufacturing in accordance with one of standard, legislation, or guideline determined in advance for the target equipment to be stored in the storage space.SELECTED DRAWING: Figure 2