What is pharmaceutical management

General information

The quality of pharmaceuticals is subject to strict regulations. The term GMP (Good Manufacture Practice) - guidelines for quality assurance in the pharmaceutical industry (established in the USA as early as 1962) - is a catchphrase that is also seen as a synonym for pharmaceutical quality beyond specialist circles. In the European Union, drug legislation is largely predetermined by EU directives, which are to be converted into national laws in the member states.

Production manager and manager of the control laboratory are the established management positions for the areas of production and quality control. With Directive 2001/83 / EC, the additional position of Qualified person (German: competent person) who now takes on the central role in quality management and quality assurance. The Qualified Person was implemented very late in some EU countries, in Austria it became a reality with the Medicines Works Regulations 2005 (AMBO 2005).

The introduction of the competent person means a restructuring of the responsibilities in the management positions of production and quality control. The competent person, whose function is often succinctly described as "responsible for batch release", has to fulfill the external guarantor function for the product quality. In addition, the qualified person takes on the central function in quality assurance and quality management.

In accordance with the responsibility of this function, the requirement profile is higher than for the first-mentioned established positions. In principle, a degree in pharmacy is a prerequisite for being able to work as a competent person. However, since graduates from related fields of study also work in the pharmaceutical industry, the requirement profile has been expanded to include some studies (see admission requirements). However, graduates of these fields of study must complete additional "follow-up training": The basic course of the university course "Pharmaceutical Quality Management" represents this follow-up training required by law.

Where is a "competent person" needed in the pharmaceutical sector?

Every company with a license according to § 63 AMG (Medicines Act) must always have a competent person at its disposal. As "§ 63 companies" or actually: companies according to § 62 paragraph 1 AMG not only count production companies, but also companies that control drugs or market them.

Who is allowed to be a "competent person"?

The following personal requirements apply to the exercise of the function of a competent person (for details see § 7 AMBO 2009):

  • Successful completion of one of the following university courses: pharmacy, human, dental or veterinary medicine, chemistry or biology or a course of at least four years recognized as equivalent
  • Proof of at least two years of professional experience in the field of drug analysis and quality control of drugs

In principle, the functions of a competent person and a control laboratory manager, such as a competent person and production manager, can also be performed by one person. However, it is not permissible for all three functions to be represented by one person.

For control laboratory managers who want to exercise the function of a competent person, special regulations apply:

  • Anyone who worked as a control laboratory manager before January 1, 1995 is authorized to act as a competent person.
  • Anyone who has worked as a control laboratory manager after January 1, 1995 and before the Medicines Works Regulations 2005 came into force, is authorized to carry out the work of a competent person, provided that they have the qualifications listed in § 7 AMBO 2005 by 31 December at the latest 2009 (see Control Laboratory Supervisor Ordinance).

It is an Austrian specificity that graduates of the pharmacy degree, who in terms of their training would have the best qualifications for the function of "competent person", primarily work in public pharmacies and institutional pharmacies. The few pharmacists who are oriented towards the "pharmaceutical industry" aspire to positions in management.

Anyone who intends to exercise the function of a competent person, but has not completed pharmacy, but another degree named in the admission requirements, must complete additional training. This "follow-up training" represents the basic course of this university course.