New authors


Christoph Frick has been working at kohlpharma GmbH since 2001. As head of quality assurance he is responsible for drug safety. Also he is a Qualified Person (QP) and Responsible Person according to GDP.  Since 2021, he has also acted as Quality Management Representative (QMR) in the course of certification according to DIN EN ISO 13485.


Ulf Fuchslueger is a consultant for laboratory data management, laboratory process optimisation, LIMS and system integration in a regulated environment. He has supported many international pharmaceutical companies during the implementation of computerised laboratory data systems.


Alexandra Fürst has been providing freelance support in the pharmaceutical industry since 2012. Her projects so far have included QA tasks such as creating SOPs, PQRs, training, deviations and change management.


Christian Gausepohl is Head of the Quality Unit and Qualified Person at Rottendorf Pharma GmbH. He has worked in many different positions and has extensive audit and inspection experience with authorities, customers and suppliers. His main concern is the practical implementation of GMP requirements.


Ralf Gengenbach founded gempex GmbH in 2002 as managing associate. Gempex GmbH is one of the leading GMP service companies with an international orientation today. The headquarter of gempex is Mannheim, further locations are Sisseln, Switzerland, and Guangzhou, China.


Margit Gieseler has been CEO of GILYOS GmbH since 2011. The pharmaceutical service provider specialises in freeze drying and provides solutions in the areas of formulation and process development, analysis and consulting as well as customised training in the area of lyophilisation.


As GMP Inspector for the Government of Upper Bavaria and the European Medicines Agency (EMA), Rainer Gnibl is responsible for carrying out national and international inspections of the manufacturers of medicinal products and active ingredients He is head of the national expert group EFG 02 "GMP inspections/GMP guidelines" and is the deputy chairman of the examination board for the 3rd pharmaceutical state examination.


Ralph Gomez works as a freelance consultant in the area of Pharmaceutical Quality Management since 2007. In the years before he was working with Hoffmann-La Roche, where he started his career in 1966. He is a member of various expert committees, advisory panels and project teams.


Bernhard Gotter has been working as Quality Manager in the Global Quality Management of Bayer AG in the Consumer Health area since 2017. During his career to date he has gained experience in supervising contract manufacturers and in the areas of quality assurance, auditing and supplier management. In the context of these activities he has led numerous audits and organised and supported regulatory inspections.


Seit 2016 ist Herr Dr.-Ing. Manfred Grüneberg bei der Ehrmann AG für die Koordination von technischen Projekten und Prozessoptimierungen zuständig. Seine Schwerpunkte liegen in den Bereichen Projektmanagement, Werksplanung und TPM-Aspekte.


Thilo Gukelberger has been managing the Life Sciences division of the d.velop group since 2007 and is responsible for the strategic approach for GxP-related software products and QM solutions. Thilo Gukelberger is co-author of "Formelsammlung zur numerischen Mathematik mit C-Programmen" (a collection of mathematical formulas for numerical methods in C programming), published by the BI Wissenschaftsverlag in 1987.


Friedrich Günnewig has been employed in quality control at Rottendorf Pharma GmbH since 1989. His main areas of expertise include cleaning validation, microbiological monitoring, raw material qualification and analytical method transfer.


Hansjörg Gutmann has worked for Testo Industrial Services since 2013. He is active as a seminar speaker on the subject of calibration. As a quality manager, he is also responsible for the GxP Services division. It focuses on calibration, validation and qualification for customers in the pharmaceutical, medical technology and life sciences industries.


Ilka Henkel has been an independent packaging consultant and auditor for suppliers of primary and secondary packaging materials for the pharmaceutical industry since 2014. One of her specialties is the auditing of typesetting studios. Ilka Henkel is a member of the SHS Pharma Team expert group and co-author of the defect evaluation lists for printed aluminum packaging and tubes.


After graduating in pharmacy and receiving a PhD, Michael Hiob worked as Laboratory Manager and GMP Inspector in the area of drug supervision. He is currently inter alia responsible for supervising GMP inspections


Jens Hrach is Global Submission Manager at Boehringer-Ingelheim. He founded his own company, Dr. Jens Hrach Consulting in 2014, supporting pharmaceutical companies in the areas of toxicology and risk evaluation.


Lea Joos has worked as a GMP inspector for the Government of Upper Bavaria since 2012. Her tasks include the monitoring of GMP and GDP operations as well as tissue facilities in accordance with § 64 AMG (German Medicinal Products Act).


Since 2005 Stefan Kettelhoit is a freelance consultant for life science companies. He has many years of experience in the areas of development, pharmaceutical technology and international project management. As a freelance auditor and consultant, he works for national and international pharmaceutical companies, manufacturers of medicinal products and packaging materials.


After graduating in Paper and Plastics Processing at the University of Munich, Roland Kleissendorf joined Grundig AG where he worked in the Packaging Technology department for two years.