CoP Containment

About

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.

Introduction

The aim of the CoP “Containment”: to offer operators, planners, manufacturers as well as interested parties who deal with containment systems in their daily work a discussion platform for technical topics and for the exchange of experiences. This objective is supported by annual expert discussions on topics in the field of “containment”. In addition, there is a regular exchange of experiences with the CoP’s of other affiliates.

Containment

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.