New authors

Jürgen Eberlein has been working as a Qualified Person and Control Sample Expert in accordance with the German Drugs Act (AMG § 65.4) in the QA department of Labor LS SE & Co. KG since 2014. He also carries out customer audits and official inspections.

Klaus Eichmüller is Head of Department II 23.2 Pharmacy at the Darmstadt Regional Council and Head of the GMP Inspectorate in Hesse.

Dr. Joachim Ermer offers consulting and training on topics related to pharmaceutical analytics and quality control, such as pharmacopoeia requirements, reference standards, analytical data integrity, life cycle management of analytical procedures, monitoring of relevant performance parameters, continuous improvement, OOS / OOT, validation, verification, transfer or practical statistics.

Martin Eßmann is an expert for ultrapure water storage and distribution systems. He is a partner of Planttech Engineering GmbH and has been responsible for the planning and building of process-related systems in the pharmaceutical liquids sector since 1998.

Javier Fernández was Senior Toxicology Officer at Azierta. He also coordinated the Mutagenic and Organic Impurities team.

Since 2012, Simone Ferrante has been Head of Quality & Regulatory Affairs in the Grieshaber Logistics Group AG. As Head of Quality Control and Responsible Person in accordance with GDP, she is responsible for the entire Grieshaber Group.

Harald Flechl has more than 35 years of professional experience in cleanroom engineering for pharmaceuticals, electronics and healthcare. He assumed various functions in the areas of planning, implementation (project management) and maintenance. His main areas of activity were media supply, ventilation and air cooling systems.

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.

As the Global Quality Director and Qualified Person of Marken Germany GmbH, Christian Gausepohl is responsible for quality and compliance issues. He previously held the position of Technology Officer and Qualified Person at Rottendorf Pharma. His responsibilities included all aspects of quality and compliance. 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.

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.

Hansjörg Gutmann has worked for Testo Industrial Services since 2013. He is responsible for business development in the GxP Services division. It focuses on calibration, validation and qualification for customers in the pharmaceutical, medical technology and life sciences industries.