ASEPTIC PROCESSES VALIDATION AS PER PIC/S
ASEPTIC PROCESSES VALIDATION AS PER PIC/S Validation of aseptic processes relies upon prospective, concurrent, and retrospective validation as well as re-validation. Prospective studies include installation and operational qualification for a new or renovated facility as well as product simulation studies and a prospective process validation with the original product according to PIC/S Document PI 006. … Read more