Annex 1 The Final Version – The impact on Contamination Control, Cleaning, Disinfection and Decontamination

A review of the regulatory guidance relating to cleaning and disinfection in the recently update EudraLex Vol.4 Annex 1, issued in August 2022. This presentation sets these regulations in context of their global reach and importance to the international state members of PIC/s. It then examines the new regulatory wording as it relates to the requirement of a Contamination Control Strategy (CCS), cleaning, disinfection, rotation, formats and in-house preparation of detergents and disinfectants, residues, validation, material transfer and training of cleanroom personnel.