Masterstudiengang "Drug Regulatory Affairs"


Preparation of a check list to perform GMP-Audits of contract manufacturers following relevant provisions of law.

Anette Keiser (Abschlußjahr: 2006)

Language: English

The legal basis concerning GMP for marketed products in Europe is provided in Directive 2001/83/EC Title IV, manufacture and importation and Title XI, supervision and sanctions. The legal provisions relating to GMP were modified by Directive 2004/27/EC (amending Directive 2001/83/EC) which Member States had to comply with by October 30, 2005. Article 47of this Directive specifies that the principles and guidelines of GMP for medicinal products referred to in Article 46(f) shall be adopted in the form of a directive. This Commission Directive 2003/94/EC of October 8, 2003 details the principles and guidelines of GMP for medicinal products.

Based on international provisions which are specified in detail by the WHO and PIC the subsequent European and German national implementation of GMP related requirement are presented in this paper.
Here focus is laid on the implementation of provisions for Quality Assurance and Good Manufacturing Practice and related inspection into the German Drug Law and the Decree on Pharmaceutical Operations (PharmBetrV) in accordance with the relevant Directive2003/94/EC.

The application of these principles is mandatory throughout the European countries referring to in-house and contract manufacturing. Second main aspect of this thesis is the evaluation of the industrial background and legal framework for contract manufacturing considering the necessary contracts especially with focal point GMP and inspections of contract manufacturing.
Finally the present paper is dealing with the compilation of a checklist to perform GMP-Audits at contract manufacturers. The paper is demonstrating that a checklist can use as a useful tool for a thematically well structured audit and for analysing the current GMP status of a pharmaceutical company.

Pages: 52, Annex: pages: 28