Abstract

Tasks and Duties of Qualified Person, Head of Production Department and of Head of QC – Current Legal Regulations and their Implementation in Small and Medium-Sized Enterprises

The requirements concerning the legal role “Qualified Person” (QP) as well as its tasks and duties are laid down on European level in Directive 2001/83/EC (refers to human medicinal products) and Regulation (EU) 2019/6 (veterinary medicinal products),¹⁾ respectively, and in Directive particularly in Title IV “Manufacture and Importation”, and in Regulation in Chapter VI “Manufacturing, Import and Export”. Concerning human medicinal products a concretisation of the tasks and duties is made in EU GMP Guidelines chapter 2.6 and in particular in its Annex 16. The EU GMP Guidelines also stipulate the tasks and duties for the roles “Head of Production Department” and “Head of Quality Control” (Head of QC).

These European statutory provisions concerning QP have been implemented in article 14, 15 and 19 German Medicines Act (Arzneimittelgesetz, AMG) and especially in articles 16, 17 and 18 of the German Ordinance for the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (Arzneimittel- und Wirkstoffherstellungsverordnung, AMWHV).

Concerning the 2 roles “Head of Production Department” and “Head of QC” also AMWHV is applicable, e.g. articles 12 to 15. Pursuant to article 3 paragraph 2 AMWHV the EU GMP Guidelines have been obtained a legal status in Germany.

At least 2 persons are needed per manufacturing site, that can combine the 3 legal roles, where Head of Production Department and Head of QC must be separated.

The tasks and duties for the 3 responsible persons, which are arising as a result of the legal stipulations mentioned above, are listed in the present article. Common tasks and duties between the responsible persons and together with further executive staff members are also considered.

A safeguarding according to the 4-eyes principle is reached with the 3 roles: While the Head of Production Department bears responsibility for the proper manufacturing, i.e. manufacturing of the batch according to the GMP rules in compliance with the registration dossier and so on at the time of producing, and the Head of QC bears responsibility for the proper tests and checks at the time of QC, the Qualified Person afterwards evaluates the manufacturing and QC of the batch again in the context of market release.