Abstract

LOPEZ, Yohanix et al. Aspects to consider for the introduction of a new manufacturing process in a multiproduct certified plant. Vaccimonitor [online]. 2013, vol.22, n.1, pp. 22-28. ISSN 1025-028X.

In this study, a risk identification method is applied for introducing a new manufacturing process using Saccharomyces cerevisiae as host cell, in a certified multiproduct plant, where intermediate products are manufactured using Escherichia coli, in addition risk control actions are proposed. The quality risk analysis was applied, with the support of basic tools and techniques as observation, teamwork, brainstorming and 6M analysis. As a result, the risks associated to the process, to the facility and to the changeover were identified. All risk control actions were implemented with the same priority during the introduction of this new process as part of Good Manufacturing Practices compliance.

Keywords : Risk analysis; multiproduct plant; changeover; cross contamination.

        · abstract in Spanish     · text in Spanish     · Spanish ( pdf )