1.The distinction between "major" and "minor" equipment is not a definitive one.
2. The CGMPs make mention (211.105) of "major" equipment, but are silent on the subject of "minor"
equipment except with regard to items described as utensils (211.67).
3.Despite this failure within the CGMPs, it is necessary to identify those pieces of equipment (major) which are
central to the production process and those pieces of equipment (minor) which perform a
secondary role.
4.Typically the cleaning of "major" equipment will be the subject of individual, highly specific
SOPs. In contrast, "minor" equipment and "utensils" are often cleaned using broadly defined
procedures which describe the methods to be used in general terms.
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