New authors


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.


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.


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.


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. Stephanie Blum works as an auditor, consultant and speaker and is the author of various expert publications.


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.


Doris Borchert has been working as an editor for GMP-Verlag Peither AG since 2008. She is responsible for reviewing expert articles. Prior to this, she worked in the pharmaceutical industry for 15 years in quality assurance, process technology and production and was actively involved in many audits and inspections.


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 2020 he is a freelance consultant for the pharmaceutical industry and medical device manufacturers.


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.


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.


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.


André Deister has been employed by Sanofi-Aventis Deutschland GmbH since the beginning of 2015 as Head of QC Packaging Material and is responsible for the testing and release of primary packaging components for insulin production in Frankfurt. 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.


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.


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.


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 managing 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.


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.