PharmSystem Technologies begins publishing some articles, FDA and HPFBI documents. All documents will be translated in Russian. They will give some ideas about basic trends of contemporary quality system development.

Keywords: quality system, good manufacturing practise, quality system department, organizational structure, personal responsibilities.

Abstract

The quality system of contemporary pharmaceutical company has some designations. Practice shows that the robust quality system, that covers all matters of the company activities, is the multipurpose tool. A system of quality should ensure that drugs are designed, developed, produced and sold in a way that takes into account the GMP requirements. Also, the quality system defends a sector of sales from the competitors and gives more possibilities to get the new markets for sale. The QC specialists know how it is hard to develop and implement the robust system.

All existing difficulties, that have QC specialists in Russia and Ukraine, are possible to group into the following problems:

1.  Absence contemporary theoretical knowledge and practical recommendations.

2.  Absence adequate resources.

3.  GMP implementation is required a long time.

The present article will give a model of QC department structure that is complied with the GMP rules.

The articles can load in Russian in PDF format.