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Ahead of initiating course of action validation actions, appropriate qualification of critical gear and ancillary units really should be accomplished. Qualification is usually performed by conducting the next activities, independently or blended:Techniques for the use of facilities should really be certain that components are managed in the method

5. Practical checking Viable checking is done on daily basis by utilizing the swab examination and employing a nutrient agar medium with the incubation of microorganisms. The several media plates are exposed in every single producing segment such as the reverse air duct from the HEPA filter in the back of the cubicle. The microorganism depend needs