1.2 Purpose
The purpose of this publication is to identify and discuss the many factors involved in the design,
validation, implementation and control of cleaning programs for the pharmaceutical industry.
The document does not attempt to interpret CGMPs but provides guidance for establishing a cleaning
validation program. It identifies the many factors to be considered for all segments of the
pharmaceutical industry. It also identifies specific points to be considered by dosage form
manufacturers, manufacturers of clinical trial materials (CTMs) and manufacturers of bulk
pharmaceutical chemicals and biochemicals. The report covers the different approaches which may
be appropriate for the different stages of product development from the early research stages to the
commercially marketed product.
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