Demand-Oriented Development of Quality Assurance Systems

Demand-Oriented Development of Quality Assurance Systems

The quality management system (QMS) of pharmaceutical manufacturers covers quality assurance and good manufacturing practice including quality control and regular product quality reviews – as written in para 3 (2) AMWHV. But how are the need and scope of a GMP-compliant QMS identified and determined? At the LOUNGES in Karlsruhe, Dr. Martin Melzer, Principal Consultant and GMP expert at gempex, will speak on May 18, 2022 at 1:00 p.m. (Room 3) about the demand-oriented structure of quality assurance systems and present the ideal-typical process of implementation of a QMS.

A QMS evolves over a longer time period. Periodic reviews are necessary to maintain the QMS in actual state and to avoid unfavorable impressions during inspections by authorities or audit of customers. Changes in the existing QMS also may become necessary due to customer or authority requirements, and due to new legal framework conditions. New business activities or even the opening of a new site require a totally new QMS to be established.

Regardless of whether a new QMS is being developed or adapted, it should always be approached in a structured way:

  1. Mapping of business activities and planned processes (e.g. goods receipt, production, analytics, release, purchasing, sales, etc.)
  2. Identification of necessary quality management processes (e.g. document management, management review, risk management, change management, deviation management, CAPA management, qualification / validation, self-inspection)
  3. Review of applicable legal regulations (e.g. Drug Laq, Narcotics Drug Law, Tissue Law, Transfusion Laq, etc.)
  4. Design of a document and responsibility matrix clearly assigning accountability and responsibility 
  5. Document preparation and implementation QMS (operational processes and quality management processes need fit to each other)

So far is the theoretical part. In order to establish or maintain an adapted and lean QMS, qualified personnel is required! Regular employee training and self-inspections create the necessary acceptance and self-evidence of the QMS and, in addition, often prevent that any weaknesses are only discovered during an inspection by the authorities, or customer audits.


Dr. Martin Melzer describes in detail the approach and procedure for a GMP compliant QMS in the publication "Aufbau normenkonformer Qualitätssicherungs-Systeme - Strukturiertes Vorgehen für die Erstellung oder Umgestaltung eines QMS", published in pharmind. The article (German language) is available for free download at

For questions on this topic, please contact Dr. Martin Melzer at any time via: or visit us at LOUNGES May 17-19, 2022, booth D1.2.