Petrus V. Organization of the transfer analytical procedure on pharmaceutical company

Thesis work is devoted to the development of scientifically based concept of transfer organization of analytical procedure for assay determination of active pharmaceutical ingredient in film-coated tablets from the development laboratory to the quality control laboratory at the pharmaceutical plant of Ukraine. A critical analysis found that the goal of demonstrating suitability was not achieved within the "classical" approach to validation. The SPU approach has consistently implemented this goal within the framework of the "classical" approach. The new Life Cycle approach abandoned the internationally recognized "classical" approach and offered significant systemic improvements over the "classical" approach to validation, but did not achieve this goal in the practical implementation of the "demonstration of suitability". To solve the existing problems and for development of science-based concept of transfer, it was proposed to rely on the basis of “classical” approach to validation, as an internationally recognized approach, and to combine the achievements of SPU approach and “Life Cycle” approach. Concept of transfer was formulated as follows. Purpose of transfer is to confirm in minimal experiment that knowledge of variation factors amplitude obtained in the Sending Unit (SU) is applied to the Receiving Unit (RU).