Determination Of Critical Control Pointsof Bacterial Endotoxin Content At Various Stages Of The Manufacturing Process Of Medicines For Parenteral Use
The article analyzes the results of studies of bacterial endotoxin content at differentstages of the technological process.
Production and quality control of medicinal products for parenteral use is extremely important process that requires
continuous improvement and optimization of the technologies in addition to the appropriate execution of the process.
Selection of control points on the stages of technological process is a part of technological development. Compliance with
Good Manufacturing Practice provides quality of the process, and validation confirms its validity and stability. At various
stages of technological process the content of bacterial endotoxins may vary. However, depending on the manufacturing
stage and applied technology the content may either increase or decrease. The article describes the results of study and
determinationthe critical points of bacterial endotoxin content measurement in order to minimize the risks of non conformity
the quality of medicinal products for parenteral use.
Keywords- bacterial endotoxins, drugs for parenteral use, LAL-test, technological process.