Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Implementation of complaint management in a sales and distribution only company for pharmaceuticals ***

Beate Schmidt-Krauthause (Abschlußjahr: 2001)

The essay describes the procedures including task assignment etc. introduced in the German subsidiary Subsid of a real world company to achieve a rapid and secure complaint handling and the subsequent measures to guarantee drug safety, both in compliance with German and European reporting requirements. Sales and Distribution constitute the core business of Sudsid, i.e. there is no manufacturing operation in Germany. The essay is mainly written in German as it focuses on the description of the German legal situation and on the implementation of the SOPs within Subsid. Some of the SOPs are written in English since Subsid cooperates in all sort of issues including complaint handling intensively with two other European subsidiaries of PharmCo, a manufacturing site (Manufacturer) and the European Regulatory and Pharmacovigilance Headquarter (Monitor).

First, the potential complaint types and the relevant German and European legal situation, e.g. regulatory issues and reporting requirements have been listed. Subsequently, a general set of requirements for a complaint handling system has been derived - focused on external complaints.

Next, based on a short profile of Subsid, the organizational requirements for such a complaint handling have been portraid by formal org charts and job/function descriptions. Specific attention has been given to the policies of personal union and deputy selection, since the manager RA simultaneously covers the functions production and control manager, commissioner for the graduated plan and information officer.

The essay's main part shows the ready-to-implement task assignments, procedures and internal policies for Subsid in form of an extract of the quality assurance (QA) handbook - see appendix for full version of the SOPs including all detailed definitions of responsibilities etc. This part covers in depth the procedures defined, the interfaces and interactions between the various jobs/functions involved both internally in Subsid as well as externally at Monitor, Manufacturer and the authorities. Separate procedures for medical and non-medical complaints have been defined; within the latter, commercial complaints have only been covered to the extend necessary to single them out. Furthermore, an emergency plan ("Maßnahmenplan") for e.g. a drug recall has been defined to secure a fast and responsible reaction. All procedures etc. have been designed considering that Subsid neither produces the respective drugs nor conducts in case of complaints any of the following root cause analysis, risk potential evaluation or definition of specific measures.

Details on reporting towards the various German and European authorities have not been included in this essay for reason of scope. Hence, the essay ends with the interface to those authorities.

Ultimately, the designed implementation for Subsid has been critically reviewed against the most important requirements set-up before: the set of procedures etc. do secure, that Subsid complies with its responsibilities towards the public and the authorities in case of complaint handling. Thereby, the QA system as described so far has to be considered as a perfect starting point for a continuous refinement based on both increasing experience as well as changing legal settings or medical/scientific advancement.

Pages: 88