Work package 6: GMP Conformity
Leader: Martin Zierau, IMS - Integrierte Management Systeme e. K.
Within WP6 the quality of the development process itself will be addressed. The main objective of IMS is to develop and apply appropriate methods and tools to achieve GMP conformity for an efficient design transfer into production from the very beginning of the activities. A subsequent “Quality by Design (QbD)” approach will be pursued. It will strive to identify and to understand the critical attributes of each manufacturing step, including inputs (materials, informations), task characteristics (e.g. equipment, process parameters, disturbing effects) and manufacturing results (materials, informations).
Description of the tasks
To ensure this the tasks of WP6 are:
- Translate the needs of the haemophilia patient group into product specifications
- Develop and apply methods and tools for a risk based product and process development from the very beginning of the development process
- Create a knowledge base
- Create a GMP-compliant Preclinical Development Dossier
The expected tool set “GMP conformity” as a major outcome of this project should enable SMEs to improve the efficiency and the quality of their development of biopharmaceutical products as well as to conduct a cost efficient design transfer.