Validation evaluation of the technological process of leonurus turkestanicus liquid extract production

Abstract

Aim. The transfer of Leonurus turkestanicus liquid extract production technology and its validation at LLC «FitOleum» (GMP compliance report conclusion CT PK 1617-2006 «Good Manufacturing Practice. Remedies production. Basic provisions» № 18, Nov. 21, 2014.). Methods. Different known statistical methods have been used to evaluate and to interpret both technological parameters and indicators that were determined during quality control of herbal material, intermediate product, and final product. A Statistical process control (SPC) concept is applied as a basis for all accepted international instruments ICH Q8 «Pharmaceutical Development», ICH Q10 «Pharmaceutical Quality System», PAT Concept, and FDA Guidance for Process Validation. Results. As a result of research normative documents that regulate manufacturing process in the test conditions have been developed. A comparable data across technological parameters of three consistently manufactured test production series have been obtained, as well as validity of the extract production technological process has been proved. Conclusion. On the basis of research, the experimental-industrial procedure for Leonurus turkestanicus herb liquid extract production at the LLC «FitOleum» has been developed