Clothing: Is it acceptable to have two levels of clothing in the non-sterile manufacturing areas, i.e., one level for operators with full gowning and coveralls and another level for QA auditors and visitors? What environmental monitoring data is required?

Yes. There are basic clothing requirements for any person entering the manufacturing areas, such as hair,
mustache and beard covering, as well as protective garments. However, a firm may decide to apply more
stringent requirements for operators, such as dedicated shoes and garments providing a higher level of
protection. There are no specific environmental monitoring requirements for clothing worn in the non- sterile
manufacturing areas.