The document is intended to cover validation of equipment cleaning for the removal of contaminants associated with previous products, residues of cleaning agents as well as the control of potential microbial contaminants.
This topic reflects an area in pharmaceutical, biological and radiopharmaceutical manufacturing that is noted as being important by both the Inspectorate and the pharmaceutical industry.
This guideline has been prepared to provide guidance to inspectors, evaluators and industry in reviewing the issues covered.
From an analytical standpoint, recovery is from the cleaning test sample (i.e., the swab).
From the cleaning program standpoint, the concern is the recovery of the residue from the manufacturing equipment.
They are essential to accurately determine amounts of residual API or formulation component in comparison to the acceptable residue limit (ARL) for a given cleaning process or equipment train (1).