alexa “Quality Tools for Improving a System of documentation as the basis for Good Manufacturing Practices”. Practical Case
ISSN : 2153-2435

Pharmaceutica Analytica Acta
Open Access

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Research Article

“Quality Tools for Improving a System of documentation as the basis for Good Manufacturing Practices”. Practical Case

Biunayki Reyes Díaz1*, Andrés Tamayo Domínguez2, Mirtha Castiñeiro Díaz3, Gudelia Pérez Monras4, Cristina García Aguirre2,Gisela Calas Dominguez2, Angela Sosa Espinosa5 and Rodolfo Valdés Veliz1

1Process Control Department, Center for Genetic Engineering and Biotechnology, P.O. Box 6162, Habana 10600, Cuba

2Monoclonal Antibody Department, Center for Genetic Engineering and Biotechnology, P.O. Box 6162, Habana 10600, Cuba

3Pharmacy and Food Institute, U.H, Habana, Center for Genetic Engineering and Biotechnology, P.O. Box 6162, Habana 10600, Cuba

4Quality Assurance Direction, U.H, Habana, Center for Genetic Engineering and Biotechnology, P.O. Box 6162, Habana 10600, Cuba

5Biosafety Department, U.H, Habana, Center for Genetic Engineering and Biotechnology, P.O. Box 6162, Habana 10600, Cub

*Corresponding Author:
Dr. Biunayki Reyes Díaz, MSc.,
Process Control Department
Center for Genetic Engineering and Biotechnology
P.O. Box 6162, Habana 10600, Cuba
E-mail: [email protected]

Received date:June 09, 2011; Accepted date: September 27, 2011; Published date: September 29, 2011

Citation: Díaz BR, Domínguez AT, Díaz MC, Monras GP, Aguirre CG, et al. (2011) "Quality Tools for Improving a System of documentation as the basis for Good Manufacturing Practices". Practical Case. Pharm Anal Acta 2:136. doi: 10.4172/2153-2435.1000136

Copyright: © 2011 Díaz BR, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

Abstract

The documentation system is one of the mandatory elements reviewed during inspections of any regulatory agency. Generally, 20 to 30 percent of the deviations detected in a pharmaceutical inspection, are directly related to the documentation of quality system in each of the components or systems inspected. Given that no regulation on GMP will tell us in detail how the documentation system should be, we aimed to show in this work an approach used to implement some of the quality tools for establishment and maintenance of GMP and inherent Documentation in order to comply with the normative, national and international regulations typical of a productive process monoclonal antibody (MAb) which is secreted by the hybridoma 48/1/5/4, specific for the “a” determinant of the Hepatitis B surface antigen (HBsAg). This MAb is routinely used as reagents for the purification of vaccines.

The work was separated into three basic stages: Diagnosis and Assessment of Specific and General Documentation of the System; Maintenance and improvements to the document system and New regulatory perspectives. The effective functioning of a documentation system in which the main objective has been to guarantee stable and solid production processes for the preparation of biopharmaceutical products, allowing the release and commercialization of a considerable number of utility batches for human health.

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