Abstract

APEZTEGUIA-RODRIGUEZ, Isabel et al. Risk-management related to the productive campaign change during technological development stage in a multi-product facility. Vaccimonitor [online]. 2020, vol.29, n.3, pp. 118-128.  Epub Dec 01, 2020. ISSN 1025-0298.

The new paradigms of the pharmaceutical industry in the 21st century introduce the use of modern quality management techniques to comply with good manufacturing practices in the biotechnological area. In this paper, it was applied the risk management for the campaign change among the process for obtaining the active pharmaceutical ingredients to future immunotherapeutic candidates at the technological development stage in a certified multi-product facility. Particularly, the training for the development personnel in the standard operating procedures of the facility, the mixture between the components and non-dedicated materials used in the chromatographic purification process, the documentation in the preparation or approval, and the establishment of analytical techniques depending on the stage of the project are the potential causes of greater influence. As a result, actions are proposed to minimize risks and carry out an adequate campaign change feasible between the manufacture of immunotherapeutics during the technological development stage in a biotechnological multi-product facility.

Keywords : Risk management; technological development; biological products.

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