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Revista Cubana de Farmacia

versión impresa ISSN 0034-7515


LOPEZ GARCIA, Yohanix et al. Quality risk analysis in a changeover. Stage of cleaning. Rev Cubana Farm [online]. 2013, vol.47, n.2, pp.147-156. ISSN 0034-7515.

Objective: to identify the general risks in the cleaning phase during changeover in a multiproduct plant for biological products and to put forward control actions to reduce them, guaranteeing to focus attention on the unacceptable identified risks and their scenarios. Methods: aquality risk analysis using the tool called Failure Mode and Effect Analysis was made, which allowed identifying pollution-associated risks and their settings, and working proactively according to the results of the risk priority number estimation. Results: it was proven that the product and the cleaning agent residues may compromise the cleaning phase. Several actions that should be documented in the cleaning procedures of non-dedicated equipment were then suggested. Conclusions: the general risks as well as their settings were identified. The implemented risk management actions reduced total risk priority number values by over 50 % in order to assure the effectiveness of the changeover operation as part of the compliant requirements for Good Manufacturing Practices.

Palabras clave : risk analysis; multiproduct plant; changeover; contamination.

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