New authors


Dr. Sabine Paris is a senior GMP expert and editor-in-chief of the GMP Compliance Adviser for GMP-Verlag Peither AG. In addition, she is responsible for the technical editing of the newsletter LOGFILE, reports from international conferences and is the technical contact for international external contacts and distribution partners. Besides that, she supports the publishing service "Toxicological Assessments".


After the foundation of the GMP publishing house in 1999, Thomas Peither was responsible for layout & production and supported the marketing. His main activity at that time was advising pharmaceutical clients as a GMP consultant (over 20 years). The changes of his activities in the last 20 years are considerable.


Christian Perlick is the head of GMP-Supply at Quasaar GmbH and is responsible for equipment qualification and the technical establishment of new analytical techniques. He has many years of practical experience in this field. Another focus of his work is software validation. Mr. Perlick is a member of the APV Task Force Data Integrity and has successfully participated in numerous audits and authority inspections (FDA).


As an independent consultant with experience in the pharmaceutical area for more than 30 years, Heinrich Prinz performs audits all over the world, runs national and international seminars, offers in-house training and supports companies to reach the regulatory compliance.


Petra Rempe works in the GMP/GDP inspectorate of the district government in Münster, Germany. After initially being responsible for the GMP supervision of manufacturing sites, her area of responsibility expanded with the increasing legal requirements and now also includes plants that have to work according to Good Distribution Practice (GDP) or the principles of good practice according to the EU Tissue Directive.


Bernd Renger has been working as a freelance consultant since 2011. He specialises in the development of efficient quality assurance systems, the preparation and follow-up of inspection, the establishment of effective deviation management and the design of sterile and aseptic processes.


Ulrike Reuter has been working for Sanofi-Aventis since 1989 in different technical positions. As an engineer in a pharmaceutical company, she strives to reconcile technical and GMP requirements. She is currently working on implementing the new Annex 15, Annex 11 and other technical GMP issues as part of operational support and project management.


Michael Rieth is a recognized expert in the field of microbiology and looks back on over 30 years of professional experience in the pharmaceutical industry. He gives presentations, provides training in his area of expertise and publishes in journals in books. Michael Rieth is involved in a number of expert associations and received the Wallhäußer award in 2013.


Rainer Röcker has been working in the pharmaceutical industry in different roles for more than 25 years. He was responsible for national and international facility construction qualification projects. He also works as a lecturer in the area of GMP, CSV, GDP, and calibration. Rainer Röcker is a GMP auditor and a recognised GAMP 5 expert.


Fritz Röder is a recognized expert in the field of water and ultrapure media technology. In addition to this specialisation he looks back on a wide range of of experience in the GMP environment. His various career stages enable him to a deep understanding of different points of view in the company.


Markus Roemer works as an independent consultant at comes compliance in Ravensburg. He is involved in a wide range of areas including the validation of computerised systems, auditing, quality management, project management and compliance management. Since 2008, he has been working as an ISPE ambassador for the DACH affiliate.


Andreas Rösch works as a project manager at Proleit AG since 2000. His emphasis lies on qualification of process control systems and implementation of the requirements of the EU and US authorities with regard to process control systems.


Markus Salemink has been working for Testo Industrial Services GmbH since 2008. After positions in the technical field service, sales and international, he is currently in charge of the Business Development Calibration division as division manager.


Christian Sander has been employed at Testo Industrial Services GmbH (TIS) since 2018. As head of metrology, he is responsible for the further development of calibration procedures and accreditation of new measurement quantities. He also coordinates the transfer of knowledge from the metrological institutes and scientific committees to the TIS laboratories.


We warmly welcome Dr. Sandkühler to the GMP-BERATER experts team!


in memoriam

Hans Schicht was a recognised expert for ventilation and clean room technology. His experience as independent management consultant was based on years of work in the construction of ventilation and clean room systems. He was a member of specialist and standardisation committees for many years and worked as a speaker and trainer in many different countries.


Dr. Siegfried Schmitt looks back on more than 30 years of professional experience. As Vice President Technical at PAREXEL Consulting, he gives advice to medical device manufacturers and the pharmaceutical industry on all aspects of regulatory compliance. His stated interest is in reliable, effective and efficient quality systems to ensure compliance and, not least, data integrity.


Stefan Schneider worked for many years in facility construction and in the pharmaceutical and cosmetics industry. One of his areas of expertise was cleaning technology for manufacturing systems.


Thomas Schreiner has been Head of Quality Management, EHS & Vigilance of the Pharmaceuticals & Devices Division since 2019. Before that, he held different positions in the company. His tasks included sterile production, qualification and validation, consultancy and compounding. He works as a speaker on specific topics in the area of GxP compliance.


Stephan Schwarze has been Head of Counterfeit Protection since 2005. He has developed and implemented processes to prevent counterfeit medicinal products and is a recognised expert in this area. He is involved in different working groups for national and international associations and holds presentations on the subject of preventing counterfeit medicinal products.