Commissioning
Figure 5.1 Equipment and utility qualification flow chart. Utilities that have no direct product contact are usually only commissioned, not qualified. This also depends on the contact the system has…
Acceptance Test and Site Acceptance Test
Factory Acceptance Test and Site Acceptance Test As mentioned above, the user specifications are usually general in nature. For example, they would say we need a V blender with temperature…
the Level of Qualification
Determining the Level of Qualification Before determining what testing needs to be performed in the Factory Acceptance Test (FAT) or any other commissioning or qualification test, one needs to determine…
Introduction
Introduction Subpart D2 of the Code of Federal Regulations is dedicated to equipment. 21 CFR 211.63 deals with design issues, 211.65 with construction, 211.67 and 68 deal with maintenance, cleaning,…
