Privatsphäre-Einstellungen

Aufgaben und Verantwortungen der sachkundigen Person, der Leitung der Herstellung und der Qualitätskontrolle

Gesetzliche Neuregelungen und ihre Umsetzung in klein- und mittelständischen Unternehmen

Ehrhard Anhalt

Bundesverband der Arzneimittel-Hersteller e.V. (BAH), Bonn

Korrespondenz: Dr. Ehrhard Anhalt, Bundesverband der Arzneimittel-Hersteller e.V. (BAH), Ubierstr. 71−73, 53173 Bonn (Germany), e-mail: anhalt@bah-bonn.de

Tasks and duties of Qualified Person, head of Production Department and head of QC / Revised German regulations and their implementation in small and medium sized enterprises

The 14th amendment of the German Drug Law (AMG) from August 2005 repealed the German special regulation, namely that two persons − called Herstellungsleiter and Kontroll- Leiter − are responsible for the manufacturing and quality control of medicinal products, and implemented the European requirement, stipulated in article 48 of directive 2001/83/EC, that the Qualified Person (Q.P.) is now responsible. The Q.P.‘s tasks and duties are layed down particularly in article 19 AMG and in articles 16, 17 and 18 of the German Statute Rules Governing the Drug and API manufacturing (Arzneimittel und Wirkstoffherstellungsverordnung − AMWHV).
Many tasks of the Q.P. come from the field of manufacturing, QC and QA, thus the heads of these departments are suitable candidates for a Q.P.
In case the finished product had different stages of manufacture and testing, even conducted at different sites, the Q.P. who certifies a finished product batch before release may rely on the conformation by one or more other Q.P.s of the compliance of intermediate stages of manufacture within a quality system which he has accepted.
The tasks of the head of production are particularly stipulated in articles 12 and 13 AMWHV in connection with section 2.5 EC-GMP-Guideline and considerably correspond with the tasks of the former German Herstellungsleiter.
The tasks of the head of QC are particularly stipulated in articles 12, 14 and 17 AMWHV in connection with section 2.6 EC-GMP-Guide and considerably correspond − with the exception of e.g. finished product batch release and reference and retention samples − with the tasks of the former Kontroll-Leiter.

Key words Aufgaben sachkundige Person • Leitung Herstellung • Leitung Qualitätskontrolle • Sachkenntnis • Sachkundige Person