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2013, Number 2

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VacciMonitor 2013; 22 (2)

Risk assessment tools in the preparation of the solutions used in the production of Quimi-Hib®

Ojeda Y, Heynngnezz L, García J, Valdés Y, González CA, Rodríguez N, Piñón D
Full text How to cite this article

Language: Spanish
References: 7
Page: 19-23
PDF size: 204.85 Kb.


Key words:

risk management, microbial load, contaminants, Haemophilus influenzae.

ABSTRACT

Among the advanced techniques of risk management are the tools of statistical support, such as histograms and cumulative frequency plots, which are the basis for the accumulation of data. An analysis of these and evaluated the influe.nce of different parameters on a particular process for making decisions. The results showed that a risk contamination of the solutions named in a laminar flow cabinet in which filtered. All buffers tested satisfactorily complied with the limits for the content of endotoxin and microbial limit. The microbial load values determined by different methods in the workplace gave values within the limits, according to the classification of areas. The sanitizing preparation tanks showed that the procedures ensured adequate removal of contaminants. It was concluded that the risks and scenarios evaluated to achieve acceptable product quality.


REFERENCES

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  2. FDA. Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval. Silver Spring, US: FDA; 2004.

  3. Bush L. From cGMPs to the Critical Path. FDA Focuses on Innovation, Quality, and Continuous Improvement - Inside and Out. Pharmaceutical Technology 2004;28(7):34-44.

  4. ICH. Harmonised Tripartite Guideline Quality Risk Management Q9. Federal Register 2006;071:32105-6.

  5. País Chanfrau JM. Establecimiento del espacio de diseño del proceso fermentativo de obtención de la insulina recombinante en Pichia pastoris. [Tesis Doctoral] La Habana, Cuba: Facultad de Ingeniería Química, ISPJAE; 2011.

  6. Fontanet Tamayo L. Contribución al enfoque de riesgo en la validación del procesamiento aséptico de vacunas mediante la simulación con medio de cultivo. [Tesis Doctoral]. La Habana, Cuba: Instituto de Farmacia y Alimentos, UH; 2008.

  7. Milá L, Valdés R, Padilla S, Mendoza O, Gómez L, García C, et al. Quality Risk Management Application Review in Pharmaceutical and Biopharmaceutical Industries. Bioprocessing Journal 2010;9(1):26-37.




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C?MO CITAR (Vancouver)

VacciMonitor. 2013;22