药物分析学报

抽象的

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

Biunayki Reyes Díaz, Andrés Tamayo Domínguez, Mirtha Castiñeiro Díaz, Gudelia Pérez Monras, Cristina García Aguirre, Gisela Calas Dominguez, Angela Sosa Espinosa and Rodolfo Valdés Veliz

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.