Introduction
On April 26, 2022, was published in the Official Gazette the Exempt Resolution N°93 dated January 19, 2022, issued by the Institute of Public Health, which instructs the National Agency of Medicines in relation to the Technical Guidelines for the validation of pharmaceutical production processes through the retrospective approach.
Retrospective validation is understood as that evaluation carried out based on past experiences, through the presentation of production documentation, with the obligation that the conditions of composition, procedure and equipment remain unchanged, thus applying to manufacturing processes already consolidated or stable.
In this sense, the guidelines have a scope for those non-sterile pharmaceutical products, with active ingredients referred to as mature, and in cases of demonstration of therapeutic equivalence when the alternative method applies.
Thus, the technical guide establishes the characteristics, criteria and requirements for retrospective validation, as well as the steps for its performance.
Contact
If you require additional information on this matter, please contact Andrea Abascal (aabascal@jdf.cl), and/or Rocío Vergara (rvergara@jdf.cl).
