Description

The new edition of the Containment Handbook of the ISPE D/A/CH Working Group Containment is now available as a German language version.

The 2nd edition of the handbook covers the familiar topics of risk assessment, containment life cycle, process requirements, technical systems, validation, cleaning and personnel, which have been revised or supplemented. New chapters include containment strategy, consideration of GMP aspects and biopharmaceutical manufacturing. The chapters of the handbook start with a definition or introduction; concepts, processes, technologies are identified and described in the form of best practices or as illustrated examples. The requirements from the new EMA guideline “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities” were also taken into account.

Another highlight of the 2nd edition is the Containment Matrix, which was developed by the Containment Working Group.

This is the german version of the handbook.