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   Guideline on Sterile Drug Products Produced by Aseptic Processing   Guideline on Sterile Drug Products Produced by Aseptic Processing

This document is produced by the Food and Drug Administration (FDA) in the USA and published in 1987. This is being revised and it is expected that a new edition will be available in 2004. Many pharmaceutical companies export their products to the USA. To be allowed to do so they are inspected and approved by the FDA. They must comply with the 'Guideline on Sterile Drug Products Produced by Aseptic Processing'.

The FDA defines two areas in aseptic processing that are of particular importance to drug product quality. These are the 'critical area' and the 'controlled area'. A 'critical area' is described in the FDA document as:

'one in which the sterilized dosage form, containers, and closures are exposed to the environment. Activities that are conducted in this area include manipulations of these sterilized materials/product prior to and during filling/closing operations'.