In ISPE D/A/CH, members are actively involved in regional working groups and the CoP’s (Communities of Practice). Through technical/topic-based workshops, discussions, and communication, best practice working papers and approaches are developed in the sensitive environment of patient safety. They serve as guidelines for the industry and the authorities. Members of ISPE D/A/CH participate in the ISPE Guides.
The topic of containment moves the pharmaceutical industry. Many newly introduced drugs are effective even in small doses – their ingredients are highly active. For patients, this development is an opportunity; for manufacturers, it is a challenge. Low occupational exposure limits and complex toxicological assessments require special measures for process safety in the laboratory and in production.
The new Containment Manual
Now available – the new edition of the successful Containment Handbook of the Working Group.
The German Containment Handbook in the 2nd edition is available as a book.
The manual covers risk assessment, containment life cycle, process requirements, technical systems, validation, cleaning and personnel. Each chapter of the handbook begins with a definition or introduction, concepts, processes, technologies are identified and described in the form of best practices or as illustrated examples. The new EMA guidelines, “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”, are also taken into account.
The working group on Linkedin
The direct contact to the experts on Linkedin:
– Richard Denk / SKAN AG
– Dr. Reinhold Maeck / Boehringer Ingelheim GmbH
– Martin Pernau / Bayer AG
– Markus Rückert / PHACOSO Pharma Containment Solution
The Linkedin group will address issues related to the handling of highly potent substances and corresponding containment solutions and will be used there to publish information, events, publications. For special questions, the members of the Steering Committee of the ISPE CoP Group can be consulted.
Vetter Pharma-Fertigungs GmbH & Co KG
SKAN AG, Chair
Dr. Friederike Hermann,
HET Filter Ltd.
Excella Pharma Source
Dr. Reinhold Maeck,
Boehringer Ingelheim GmbH
Bayer AG, Co-Chair
AiCuris Anti-infective Cures Ltd.
Pharma Containment Solutions
Dr. Martin Schöler,
Fette Compacting GmbH
Dr. Andreas Schreiner,
Novartis Phama AG
R-Pharm Germany GmbH