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.

Petra Berlemann has been working in various areas of quality management since 2007.

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 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".

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.

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 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.

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 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.