Process Validation

According to IN 138, chapter 1, session lll, art. 3rd item XXIX – process validation is: “documented evidence that a process, operated within pre-established parameters, can perform its functions effectively and reproductively for the production of a medicine within its pre-established specifications and quality attributes. settled down."

Process validation is divided into 3 distinct validations:

• concurrent validation: validation carried out in exceptional circumstances, justified by the benefit to the patient, where the validation protocol is executed concomitantly with the commercialization of validation lots;
  
  
• prospective validation: validation carried out before the production of commercial batches;
  
  
• retrospective validation: validation carried out that involves the evaluation of past production experience, under the condition that the composition, procedures and equipment remain unchanged;