Area Grading

The "where's" and the "when's" of environmental sampling are functions of the activities in an area according to their perceived risk to asepsis and to the degree of protection required. The Guide to Good Manufacturing Practice for Medicinal Products (MCA, 2002) requires that areas are graded A to D on this basis. This grading system is only mandatory in the E.U. There is no reason why sites that do not have to comply with E.U. regulations should not choose another classification system. For instance the 1987 FDA Guideline (FDA, 1987) and its proposed revisions recommends grading of areas as "critical" and "controlled." Either way, the principle is that areas must be graded with respect to the risk to asepsis. The approach to grading should be contained in the policy document.

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