GQMA publications are available for GQMA members via login to the member area, non-members will be directed to the contact form. Please specify the presentation you are interested in there.


The PM QM – published by DeGePe GmbH on behalf of the German Society for Pharmaceutical Medicine e.V. (DGPharMed) and the German Quality Management Association e.V. (GQMA) – is published three times a year – in February, June and October. The journal was first published in 1985 as Pharmaarzt, then as FÄPI-Intern, from 1999 to 2010 as DGPharMed News and from 2011 to mid-2018 as Pharmaceutical Medicine. Since the end of 2018 it has been published under the name PM QM and is now the specialist journal of both associations, DGPharMed and GQMA. Since the beginning of 2022 the journal is only available in an electronic format.

The PM QM focuses on the technical and regulatory requirements that essential for the clinical development and market surveillance of drugs and medical devices, as well as quality management in all GxP areas. The magazine informs about innovations, events, experiences and controversies related to these topics.

Readers of PM QM are specialists and decision-makers from industry, authorities and clinics who deal with clinical development, market surveillance and quality management of drugs and medical devices. Subscribers are all members of the German Society for Pharmaceutical Medicine e.V. (DGPharMed) and the German Quality Management Association e.V. (GQMA).

 Our members receive the current issue of the PM QM electronically in the members’ area.


The working groups of the GQMA issue publications that are free available to the members and to non-members upon request (see below). GQMA books can be obtained through GQMA or the publisher.

Elektronische Archivierung im GxP - regulierten Umfeld

(In German only)

„Was sollte ein GCP-Auditor wissen und können?“

(In German only)

Since November 2010, an expert team of auditors from the GQMA GCP quality management working group has been dealing with the subject of auditor training. Experience has shown that the success of an audit essentially depends on the qualification of an auditor. Not only the specialist knowledge, but also a high level of social competence and communication skills are of crucial importance in order to be successful in this environment. This brochure is the summary of a more than 80-page manuscript by the authors, in which the essential contents of a well-founded training and further education were worked out. 

„Audits in GCP and Beyond - 3. revised and enlarged edition from 2015“

Audits are an important tool for quality assurance in the development of drugs and medical devices with regard to the well-being of study participants, the integrity and validity of study results, and the transparency of processes.

This book, already in its 3rd, revised and enlarged edition, offers a comprehensive overview of the methods and procedures of auditing in the clinical area (GCP) and the areas connected to it, such as e.g. manufacturing (GMP), pharmacovigilance (GVP), laboratories (GCLP) as well as non-interventional studies (NIS) and studies with medical devices. All phases from planning to completion are described and the different types of audits in clinical research and related fields are presented. Other areas are the auditing of computer systems and archives. The topics of risk management and inspections are also addressed here.

Everyone who works in the pharmaceutical/biotech industry, in Contract Research Organizations (CROs) and academic institutions or commercial establishments benefits from the comprehensive know-how of the authors, who offer their entire QA experience in all areas of auditing here. Auditors can deepen and expand their specialist knowledge; anyone expecting an audit will find out what auditors focus on in the various audits.

Series: pharmind serie dokumentation
Author: German Quality Management Association e.V. (GQMA) with contribution of 32 experts
Language: Englisch
Edition / Year of publication: 3., newly revised and enlarged edition / 2015
Volume: 288 pages, format, cover: 148 x 210 mm, paperback
ISBN: 978-3-87193-410-0; ECV-Verlag Artikel-Nr.: 783871


The test facilities are increasingly moving to digitalizing archive material from paper archives via scanning processes and saving them as electronic documents and storing them electronically. It quickly becomes apparent that there are no detailed guidelines for implementation.

The members of a sub-working group (IT/Archiving) have therefore dealt extensively with all questions relating to this topic and have summarized the results of their research and certain assumptions about the process from the digitalization of a document to its destruction in the form of a small brochure. They have created a handout that enables those who have to deal with the digitalization of documents to get suggestions on how to avoid problems with the long-term archiving of documents in the GxP environment.


„Canary Books“

Canary Books is an English publisher offering books, posters and newsletters for clinical research and GCP. This also includes GCP brochures for investigators in many different languages.

Canary Books offers special conditions for members of the GQMA. Please enter the required code in the “Coupon Box” at the end of the order

The code for members can be found in the member area.

„GLP Handbuch für Praktiker“

(In German only)

For GLP beginners, but also as a very useful reference for everyone who works in the GLP area, we recommend this GLP Handbook for Practitioners. The second edition was published on April 1, 1998.

Authors: G.A. Christ, S.J. Harston, H.-W. Hembeck, K.-A. Opfer
GIT Verlag: 57,90 Euro

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