Introduction and consistency of HeberFERON production in the Parenteral Products Plant 3

Abstract

The National Center for Bioproducts is an installation that is mainly dedicated to the production of low-volume liquid and lyophilized parenteral products. As part of the continuous improvement process, a new parenteral product plant (PPP3) was built. The aseptic process of formulation, filling and lyophilization must be validated, since this is the way to demonstrate that a sterile product can be obtained consistently. Therefore, this work is carried out with the objective of obtaining documented evidence that all the operations are carried out according to the regulations of Good Production Practices of sterile products in the Parenteral Products Plant 3. The simulation of the productive process showed no growth of microorganisms in any of the samples incubated from the executed runs, which allowed the formulation of the production lots. Both the introductory batches and the other batches produced up to the completion of this work have had conforming results according to the established specifications. Finally, the production of HeberFERON in PPP3 obtained the manufacturing license and all the conditions are fulfilled to accomplish the planned plans.