Modelo de evaluación de proveedores basado en riesgos aplicado a la industria farmacéutica de hemoderivados

Author

Pomares Vargas, Angel E.

Abstract

The selection and evaluation of suppliers is an essential aspect in the supply chains of companies, taking into account different parameters to select those key suppliers. In the particular case that these suppliers are part of the pharmaceutical industry, and more specifically, the production of blood products from human plasma, they must comply with GMP standards, as well as with the requirements of regulatory agencies. such as the AEMPS in the case of Spain, and the EMA, as European regulations apply. In addition, they can be certified and/or accredited by different organizations so that they show a commitment to quality and risk management.
To understand the context of this TFG, a description of the company and the Holding in which it is located is made, in addition to delving into the raw material, human plasma for fractionation, as well as the types of suppliers evaluated, centers of plasma donation and transport companies and the different regulations, guides and applicable accreditations.
The starting method for evaluating plasma donation providers is presented based on the PIC/S, which includes three types of risks (intrinsic, compliance and variable). An alternative method that modifies some parameters is proposed and the results obtained for 122 Plasma providers with the two models are compared. In addition, it adapts to 14 transport companies.

Director

Blanco Roca, Mª Josefa
Martinez Mendoza, Manuel

Degree

IQS SE - Undergraduate Program in Biotechnology

Date

2022-09-18