GMP-Anforderungen an die Qualitätskontrolle/Qualitätssicherung in der Wirkstoff-Produktion
Beispiele aus dem Wirkstoff-Betrieb
Dr. Christof Schönborn
Astra Zeneca GmbH, Abt. Pharma Fertigung, Plankstadt
GMP Requirements for Quality Control/ Assurance in the Manufacturing of Active Pharmaceutical Ingredients / Examples from Manufacturing Plants
For the manufacturing of active pharmaceutical ingredients (APIs) GMP requirements for quality control and quality assurance have to be met. Some requirements are described in ICH Q7A GMP Guide for APIs (e.g. Chapter 11 Laboratory Controls) which will be discussed in the following paper in more detail. Illustrated by examples from documentation, product quality, (quality-) monitoring, batch release, batch analysis, certificates of analysis, sampling and retained samples as well as validation it is shown what we should take notice of or what is required. Requirements, regulations and guidelines which are also necessary in terms of quality assurance for APIs are also introduced, respectively indicated within the chapters and, if necessary briefly explained.
Key words GMP-Anforderungen · ICH Q7A Guide · Qualitätskontrolle · Qualitätssicherung · Wirkstoff-Produktion
pharmind 2003, Nr. 7, Seite 695