Set-up of Standard-Compliant Quality Managements Systems - Structured Approach for the Creation or Redesign of a QMS

The obligation to have a comprehensively designed and correctly implemented quality assurance system applies to all facilities and establishments dealing with medicinal products. On startup of companies and on essential structural changes of companies, the necessity comes along to set up a quality assurance system, or to have a fundamental restructuring.

Also, customer audit or inspections by competent authorities which reveal major or even critical observations from the existing regulatory standards can result in the consequence to have a holistic review of the quality assurance system. 

How do you proceed in a structured manner? What needs to be taken into account? How can the contribution be measured to increase the efficiency of a QMS?

These questions are answered in the technical article by Dr. Martin Melzer, Principal Consultant at gempex GmbH. It presents a structured approach to setup or to transform a quality assurance system. A condensed overview, a recommended course of action.

Based on many years of experience across industries and, also on the expertise from industry, consulting and inspector activities, Dr. Martin Melzer describes the key points: 

  • Identification of business activities
  • Identification of required quality management processes
  • Identification of relevant legal requirements/technical standards
  • Definition of the document hierarchy
  • Preparation of the SOP and other documents
  • Implementation phase
  • Ongoing monitoring of the functioning of the quality assurance system


Thus, the article offers a valuable orientation and guideline for drug manufacturers, wholesalers, trader, and pharmaceutical entrepreneurs that have to maintain a quality assurance system (EU GMP/GDP Guideline or also §3 AMWHV (German ordinance)). 

The German language article can be requested via

The author, Dr. Martin Melzer, will be happy to answer questions: .