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 TH

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 【課題】 対象設備について予め定められた基準、法令、またはガイドラインのうちの一つに沿った製造のための妥当性確認方法を提供しようとする。【解決手段】従来の妥当性確認方法にかわって、製造中の対象設備をＮ組の生産ユニットが連結部で互いに連結されたものとして特定し、Ｎ組の生産ユニットを収納可能な収納空間を形成する建屋を準備し、対象生産ユニットについて予め定められた基準、法令、またはガイドラインのうちの一つに沿った製造のための妥当性確認をし、前記収納空間に収納される対象設備について予め定められた基準、法令、またはガイドラインのうちの一つに沿った製造のための妥当性確認をする、ものとした。【選択図】 図２