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2015, Number 3

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Rev Cubana Farm 2015; 49 (3)

Risk-based approach from the development phase of 100mg infant succinylcoline product

Burguet LN, Trimiño RJA, Alfonso CL, Cardoza LD, Muñoz HJA

Language: Spanish
References: 19
Page: 416-424
PDF size: 247.33 Kb.


ABSTRACT

Introduction: the guidelines presently issued by the Food and Drug Agency of the United States considers that processes fail because the sources are not duly identified, eliminated or controlled and submit a new approach of Good Manufacture Practice based on risks.
Objective: to apply a risk-based approach to the quality assurance from the development phase of the 100 mg succinylcoline product.
Methods: the process was briefly described through a block diagram with Failure Tree as a tool for identification of possible sources of failures; the risk assessment based on the detection of the possible sources of failures was made with the matrix method. An order of priority was given in the implementation of corrective actions to eliminate or mitigate the risk of occurrence.
Results: the block diagram allowed knowing the process, which contributed in a decisive way to a better application of risk management. The Failure Tree proved to be useful when showing in a graphical way the different failure combinations and interrelations between cause and effect that might give rise to the unwanted top event. The method for the risk assessment made it possible to determine priorities, being the long time of filling (not within 2 to 8oC) the critical component to be specially considered if one takes into account that stability of the product may be affected by higher temperatures, therefore, a plan of corrective actions according to the identified risks will allow their elimination or mitigation.
Conclusions: the risk management tool allowed identifying the main processrelated sources of failures from the very development phase of the 100 mg succinylcoline product.


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