Implementace kontinuální verifikace procesu ve farmaceutické výrobě

Abstract

Pharmaceutical production of high-quality, effective and safe medicines requires a well-set manufacturing process. Verification that the manufacturing process can efficiently and reproducibly produce medicines that meet preset criteria within specified parameters is done as part of its validation. The diploma thesis deals with the third phase of validation called „continued process verification”. The aim of this work is to design and implement a system of continued process verification in the environment of the pharmaceutical company producing active substances for medicinal products, which will ensure continuous monitoring that a validated manufacturing process remains under control during commercial production.