World Health Organization guidelines on transfer of analytical methods of quality control for medical preparation

Abstract

This review contains the recommendations of the World Health Organization for the transfer of analytical methods of quality control for medical preparation. Due to the absence of the Russian documents describing in detail the technology transfer process, pharmaceutical developers and manufacturers should refer to international guidelines. One of the main documents which fully describes the process of pharmaceutical technologies transfer is World Health Organization guidelines on transfer of technology in pharmaceutical manufacturing. The recommendations are presented both for the transfer of medical preparation manufacturing and transfer of analytical methods for quality control for a medical preparation. This review contains the recommendations for the transfer of analytical methods only.