GMP:Blog

Authors from A to Z: Find an alphabetical list of our authors in the GMP Compliance Adviser. Click here!

Xenia Dimont works as a GMP/GDP inspector for the government of Upper Bavaria.

Raimund Brett is a Principal Consultant at gempex GmbH.

Peter Schober is Principal Consultant at gempex GmbH and advises clients in the life science industry in the areas of IT compliance, computer system validation and organisation.

Thomas Altmann is Principal Global Technical Consultant for the Ecolab Life Sciences Division. He has more than 24 years of professional experience as a technical consultant in cleaning, cleaning validation and hygiene concepts of product-contacting surfaces in the pharmaceutical and biotechnological industry, cosmetics industry and API production.

Ana María Castro was GxP Compliance & Safety Manager at Azierta. Her role was to support the clients in the risk evaluation of their products and processes as well as in their approaches for the safety improvement and compliance.

Marta Rodríguez is a Biologist, Master’s Degree in Pharmaceutical Industry and Master’s Degree in Business Administration. She is passionate about science, health and technology, and throughout her professional career she has specialized in the pharmaceutical and life sciences industry.

Graduate engineer (UAS) Christoph Brewi is the team leader responsible for the GxP compliance department at CLS Ingenieur GmbH. He and his team support various clients with specialised, high-quality GxP services.

Florian Sieder is the Branch Manager responsible for the Vienna office of CLS Ingenieur GmbH. He leads a group of experts who provide high-quality GxP services in the areas of engineering, qualification, validation and standard-compliant process instrumentation.

Diana Westerbarkey is a process group leader at Rottendorf Pharma GmbH and is responsible for the qualification of equipment in the areas of laboratory, production and packaging. Diana Westerbarkey has many years of professional experience in the areas of quality assurance, quality control and auditing and inspection.

Steffen Wöllner is an expert in the automation of pharmaceutical water, ultrapure media and industrial wastewater plants. As Central Branch Manager, he provides services, consultancy and training in these areas. He is also an active author and speaker.

As a Principal Consultant at PAREXEL, Michael Craig helps clients prepare their CTA, marketing authorisation and variation submissions as a CMC Subject Matter Expert and provides regulatory and technical input for lifecycle activities in European and international markets.

After graduating in Law, Volker Lücker worked as a researcher in the Department of Criminal and Medical Law at the university.

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.

Dennis Sandkühler is responsible for quality management at Digital Life Sciences GmbH. He is responsible for the introduction of GxP-relevant software solutions and computer system validation in customer projects. Previously, he worked in the development and regulatory affairs for medical devices. Dennis Sandkühler is a member of the ISPE D/A/CH and author of numerous technical publications.

Barbara Unger formed Unger Consulting, Inc. to provide GMP auditing and regulatory intelligence services to the pharmaceutical industry, including general GMP auditing and auditing and remediation in the area of data management and data integrity.

Norbert Waldöfner has been working for blue inspection body GmbH, an ISO 17020 type A accredited service provider for GMP audits, since 2011. Since then, he has audited more than 200 companies worldwide, including manufacturers of starting materials and active ingredients for pharmaceutical products, as well as other suppliers and service providers (e.g. packaging manufacturers and logistics companies).

Vera Werner has been working at Novartis Pharma Produktions GmbH since 2015. She fulfilled the role of process expert in packaging here until the summer of 2021. During this time she has gained a lot of experience in all aspects of the packaging process. Especially the continuous development and adaptation to new regulatory requirements provided deep insights into various systems.

Subsequently, Vera Werner took over the management of QA Compliance at the site and is responsible for a wide spectrum of GMP compliance matters. Since September 2022, she has been Laboratory Manager for Starting Materials.

Mark Tucker is the Founder and President of Mark Tucker, LLC, a consulting firm specializing in Inspection Management and GMP training. Mark has over 15 years experience in the area of Pharmaceuticals, including experience at FDA as an Investigator, Analyst, Compliance Officer and finally Investigations Branch Director.

Silke Ohlendorf works in quality assurance at SK Pharma Logistics, where she is responsible for deviation, change and risk management. Other focal points of her work are the qualification of facilities and rooms as well as process validation in the logistics environment.

She also creates standard operating procedures and conducts employee trainings.

Dr. Olaf Mundszinger is the founder of A&O Pharma GmbH, which since 2019 (initially as A&O Pharmadienstleistungen) has been offering consulting services for the pharmaceutical sector as well as releases of medicinal products and clinical investigational medicinal products. His main focus is the monitoring of GMP-compliant manufacturing and batch release of clinical investigational medicinal products. The focus of his activities is on the supervision and GMP compliant manufacturing and batch release of investigational medicinal products and products intended to sale.

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.

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.

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.

Markus Kopf has been employed at Testo Industrial Services since 2012. As division manager he is responsible for about 50 employees of the GxP Service. These calibrate, qualify and validate throughout Germany for customers from the pharmaceutical, medical technology and life sciences sectors.

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).

From 2015 to 2019, Paulino Alonso worked as toxicologist and GMP cosultant at Azierta. He led more than 50 projects of implementation of ICH Q3D. He was responsible for internal training, revision, customer service and development of tailor-made implementation strategies.

Frank Böttcher is a pharmacist who has specialised in pharmaceutical analysis. He looks back on a long career as a qualified person and in the management in various companies of the pharmaceutical industry. Since 2021 he is working as Managing Director and Qualified Person at HWI pharma services GmbH.

Hannes Dittinger worked for many years as a chemical engineer in research and production before specializing in the field of computerized systems. Today, he is a Computerized Systems Representative and deals, among other things, with the qualification of computerized 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.

Richard Denk has been working in the areas of hygienic design, containment and the production of highly active substances for over 20 years. He has been head of the containment group for the production of highly active substances since 2014. He developed the Containment Pyramid and founded the Containment Expert Group of the ISPE DACH. Furthermore he was the initiator and responsible for the ISPE Containment Handbook published in 2015.

Dr Martin Wesch is a lawyer and co-founder of the law firm WESCH & BUCHENROTH in Stuttgart. The firm specialises in business and commercial law. From 1994 to 2011, he was Managing Director of the Gütegemeinschaft Pharmaverpackung e.V. (registered quality grading association for pharmaceutical packaging – dissolved).

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.

Professor Markus Veit is the Managing Director of ALPHATOPICS GmbH in Kaufering, Bavaria. He is also a member of the Committee for Pharmaceutical Chemistry of the German Pharmacopoeia. In his academic teaching activities he holds lectures at the universities of Frankfurt and Berlin.

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.

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.

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.

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).

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.

Olaf Stoll has many years of professional experience in the area of heating, ventilation and air-conditioning. For the past 25 years, he has worked primarily in the pharmaceutical and cleanroom technology sectors. He has taken part in a number of different audits and frequently performs Quality Assurance assignments for various projects.

André Deister has been employed by Sanofi - Aventis Deutschland GmbH as Head of OC Packaging Material since the beginning of 2015. In the meantime, he has assumed overall responsibility for packaging material control, which also includes secondary packaging materials, processing aids and single-use systems. He has many years of experience in the testing and release of pharmaceutical packaging materials and has carried out many supplier audits at manufacturers of packaging materials.

Sabine Mendel has been working as Packaging & Artworks Senior Specialist for Wörwag Pharma GmbH & Co. KG since July 2016. Her main task is the coordination of the entire go-to-market process of printed secondary and primary packaging materials, as well as artwork creation/modification.

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.

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.

Cornelia Wawretschek has many years of practical experience in the fields of pharmaceutical processes and analysis with a focus on the development of solid, semi-solid and liquid dosage forms, sterile production and investigational medicinal products. She worked as a freelance consultant for many years.

Melanie Braun works at Labor LS SE & Co. KG in the Microbiological Services section and is responsible for industrial hygiene, microbial identification, the maintenance of reference strains, and culture media. She also conducts training seminars and offers customers individual practical training courses.

Thomas Trantow provides in-house training and consulting in almost all areas of pharmaceutical quality control. He is currently working on trend analyses, evaluation of stability studies, analytical method validation and Excel in GMP applications (data integrity in Excel applications).

Jürgen Ortlepp is Head of QA, DACH (Germany, Austria and Switzerland) at Pierre Fabre Pharma GmbH in Freiburg since September 2023. During his career, he has acquired extensive expert knowledge in the areas of GMP and GDP. He is a lecturer at the Provadis School of Business and Technologies in Frankfurt and at the Fresenius University in Wiesbaden.

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.

As a senior operations manager, Frank Kugler is responsible for Microbiological Services at Labor LS SE & Co. KG. He also works as a trainer and is a safety expert. An expert in industrial hygiene, he advises customers when issues arise in this area.

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.

Markus Limberger is co-founder of the QUASAAR GmbH which has been providing GMP consultancy in product development and product control to the pharmaceutical and life sciences industries since 2015. His areas of expertise include method transfer, OOX process, qualification of standard substances and reagents, auditing and increased efficiency in the laboratory.

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.

Mr. Arslan completed his training as a mechatronics technician (automation technology) at Merck KGaA in Darmstadt from 2010-2013. After completing his training, he continued to work there as a mechatronics technician for a maintenance team in the solids production. During this time, he also successfully completed his further training as an industrial foreman in electrical engineering in 2015.

Stephanie Blum is the owner and CEO of the cirQum consultancy in Frankfurt which she founded in 2008. The molecular biologist had previously worked in the biotechnological and pharmaceutical industry at managerial level for 10 years.

After graduating in Mechanical Engineering with a focus on fluid mechanics, Thomas von Kahlden became a researcher at the Fraunhofer Institute in the area of clean room technology. He founded his own company in 1996 which develops and produces measurement and testing equipment for clean room technology and carries out all types of clean room-related measurements and qualifications.

Andreas Nuhn has been working as a freelance consultant since 2013. He uses his long years of experience in GMP compliance projects but also when preparing FDA audits and various training events. His areas of expertise include clean room planning and operation as well as the operation of isolators.

Silke Schwiertz has been Head of Quality Management and Assurance since 2010 and is responsible for the QM system of Medice and its subsidiaries. She is also the Quality Management Officer for senior management and a Qualified Person.

Simone Ferrante is Director Quality at Fisher Clinical Services at the Clinical Trials Division of Thermo Fisher Scientific. In this role, she is committed to ensuring the highest quality standards in clinical research.

She is also an author of specialist literature and practical tools on the subject of GDP for the GMP Verlag Peither. She also shares her expertise as a speaker at the PTS Training Service.

Nicola Spiggelkötter has been a freelance consultant since 2009. She provides consultancy for companies in the areas of pharmaceutical logistics, transport service providers, strategy consultancy, validation and qualification based on many years of experience in the pharmaceutical industry. Her other areas of expertise are cold chain and process optimisation.

Torsten Knöpke is responsible for the newly established LifeSciences division at Ecolab Deutschland GmbH since 2016. LifeSciences focuses on hygiene concepts and solutions in the pharmaceutical industry in the area of cleaning and disinfection as well as cleaning technology and validation of processes.

Susanne Schweizer is a Qualified Person and leads the QA Pharmaceutical Projects team together with Heike Meichsner. Among other things, she is responsible for the coordination of pharmaceutical projects of Dr. Falk Pharma and the GMP system to ensure regulatory compliance. The focal points of her long professional career include quality management, training, complaints processing and stability management.

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.

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.

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.

Roland Kleissendorf has been working as a freelance consultant in the area of packaging materials technology since 2012. He previously held a senior position in a multinational company where he was responsible for the packaging materials product range. As a consultant, he has completed a large number of different projects successfully. His motto is: "simple packaging".

Heike Meichsner is is a Qualified Person and leads the QA Pharmaceutical Projects team together with Susanne Schweizer in job sharing.
She looks back on many years of professional experience with a focus on consulting in quality management, product and process development as well as stability management and quality systems.

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.

Nicole Kordek has many years of experience in the areas of Quality Control, Quality Assurance and Regulatory Affairs. Since June 2020 she has been working for Wessling GmbH, Münster as Qualified Person and Regulatory Affairs Manager.

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.

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.

As a freelance GMP trainer, Christine Oechslein provides internal GMP training for pharmaceutical companies, manufacturers of active ingredients and suppliers. She has worked in the pharmaceutical industry for many years. As a speaker for different event organisers and an author, she shares her GMP knowledge in the areas of process validation, GMP training and GMP in development.

Siegfried Schmitt provides consulting services to medical device manufacturers and the pharmaceutical industry on all aspects of regulatory compliance, particularly the design and implementation of quality management systems and competitive compliance. His declared interest is in reliable, effective and efficient quality systems to ensure compliance and, not least, data integrity.

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.

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

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.

Thomas Schreiner has been Head of Quality Management, EHS & Vigilance of the COO Organisation since 2022. 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.

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.

Dr. Sabine Paris is a senior GMP expert and was editor-in-chief of the GMP Compliance Adviser for GMP-Verlag Peither AG until 2024. 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".

in memoriam

Wolfgang Mahl was self-employed since 1980 in the field of clean room, air conditioning and laboratory technology. Since 2008 he worked as an external consultant for planning, consulting and delivery of cleanroom components. In addition, he was involved in standards committees and working groups.

Since 2019, Martin Mayer is Vice President and Head of the Manufacturing Quality Assurance Competence Center with global responsibility for production-related quality assurance issues. These include quality risk management, root cause failure investigation, technical compliance, visual inspection, container closure integrity, process control strategies, process validation and many more.

Ruven Brandes became Head of Technology and Compliance Support for technical QA in 2006. He combines technological expertise with a strong quality awareness and possesses a broad range of professional experience. Ruven Brandes is involved in a number of different associations and committees and also works as an author and speaker.

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.

Cornelia Bodinet specialises in medicinal plants and their microbiological and pharmaceutical quality requirements. She is also an expert in pharmaceutical analysis, pharmacology and toxicology, quality control, quality assurance and sanitation.

Annette Könemann has been Head of Quality at Labor LS SE & Co. KG since 1994. In July 2019, she was appointed authorized signatory and has been representing the department "Integrated Management System" since then in the management. She was technically responsible for ensuring compliance with national and international regulations in the testing of pharmaceuticals and medical devices.

Herbert Bendlin is a recognised expert in the field of pharmaceutical water. As a freelance consultant, he provides services, consultancy and training in this area. He also works as an expert, author and speaker.

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.

Anton Steurer has been with Takeda since 1995. After being responsible for different validation topics (e.g. facilities incl. control systems and process control systems), he is now responsible for representing qualification in projects at the manufacturing site in Vienna.

Hanfried Seyfarth is a renowned expert in the field of microbiology. During his career, he held different positions, including Head of the Laboratory for Microbiological Quality Control, Head of QC and Head of Microbiology.

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.

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.

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.

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.

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

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.

From 2007 until his early retirement in 2018, Josef Künzle worked for Basilea and has been Head of Global Quality Management with responsibility for all GxP areas since 2013. He had previously worked in the pharmaceutical industry for 18 years in the areas of analytical R&D, quality control and quality management. He has taken part in official inspections and global supplier audits.

Doris Borchert is a senior GMP expert and editor-in-chief of GMP BERATER for GMP-Verlag Peither AG. In addition, she is responsible for further publishing products, for example the technical editing of the german SOP for the pharmaceutical industry and she supports the development of new publishing products and is the technical contact for "Ask our Experts".

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