4.5. Validation of cleanrooms
{"Image DocumentName": "4.5. Validation of cleanrooms", "Image ImageDescription": "Validation is defined as the establishing of documented evidence which provides a high degree of assurance that a planned process will consistently perform according to the intended specified outcomes. Once the system or process has been validated, it is expected that it remains under control, provided no changes are made. In the event that modifications are made, or problems occur, or equipment is replaced or relocated, revalidation is required. One very helpful practice is to make up a validation master plan. This document will guide the validation of all the equipment and spaces. Validation of cleanrooms should be performed according to the validation master plan. Validation of cleanrooms is performed in three phases: installation qualification (IQ), operational qualification (OQ) and. performance qualification (PQ). These qualification procedures are closely linked to the design of the cleanrooms and their aim is to show that the cleanroom has been built according to the design requirements and that it provides the required environment for the safe production of pharmaceuticals.", "Image XResolution": "37", "Image YResolution": "37", "Image ResolutionUnit": "Pixels/Centimeter", "Image Software": "SlidePlayer", "Image YCbCrPositioning": "Centered"}