GMP ANNEX 1: DISINFECTANT RESIDUES - MITIGATION AND MANAGEMENT

Within the new GMP Annex 1: Manufacture of Sterile Products the references to cleaning and disinfection have been expanded, and the terminology of “cleaning” has been replaced with “cleaning and disinfection”. The text notes that "for disinfection to be effective, cleaning to remove surface contamination must be performed first”.

However, there are currently no approved or validated methods for assessing the amount of residue on non-product contact surfaces and there is no definition or standard of what constitutes a “no” or “low residue” disinfectant. Many common and well-used disinfectants leave significant residues on a surface, which can have a detrimental effect on the biodecontamination control program. In this session we will look at commonly used cleanroom disinfectants, the residues they leave and suggest some practical approaches to tackle this issue.

Webinar Resources

• Learn more about the Annex 1 Update

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