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

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.