New authors

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.

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".

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.

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 is technically responsible for ensuring compliance with national and international regulations in the testing of pharmaceuticals and medical devices.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.