Regarding the following new GMP requirement:
EU Annex 1 (2022):
“More than one type of disinfecting agent should be employed to ensure that where they have “different modes of action”, their combined usage is effective against bacteria and fungi.”
If a sterile pharmaceutical production facility uses only 2 disinfectant products which are periodically rotated:
One of which its active ingredient is one of the chlorine releasing agents (e.g. NaOCl or NaDCC) which are known to have a mode of action “generally” categorized to be “Oxidation”.
While the other disinfectant its active ingredient is a combination of H2O2 and Peracetic acid which are known peroxide compounds which are known to have a mode of action “generally” categorized to be “Oxidation”.
1- Is this sterile production facility with these 2 rotating disinfectants (Chlorine , Peroxides) considered to be complying with the new GMP requirement previously stated although the modes of action of both disinfectants seems to be “generally similar” (Oxidation) although there are some differences regarding their target sites ?
2- If not, Will replacing “one” of the mentioned 2 rotating disinfectants with another disinfectant whose active ingredient is a QAC or a triamine or a combination of both render the sterile production facility complying ?