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Workshop: Planning and realisation of new- and reconstruction in the GMP field

What should a production facility for medicines look like? What do you have to consider for new- and reconstructions? How do you plan projects like this? What are the regional requirements in different countries?

Those questions and many more are answered in a workshop organised by action medeor with the topic „ GMP-conform constructing“. GMP stands for „Good Manufacturing Practice“ and includes guidelines for quality assurance of production processes and environment during the production of medicines and active ingredients. Particularly in Africa required technical knowledge and an expertise by the manufacturer but as well as by the supervisory authority is missing.

To strengthen pharmaceutical structures on the long-term, a knowledge transfer has to take place. This gap was recognised by the East African Community (EAC) and Gesellschaft für Internationale Zusammenarbeit GmbH (GIZ) as well and they developed a schedule to improve the quality of the pharmaceutical production at regional drugmakers (EAC GMP Roadmap).  In line with it, in September 2018 action medeor organised a Workshop in Moshi, Tanzania: in the space of four days employers of regional drugmakers and supervisory authorities gained basic knowledge of GMP-conform constructing with the help of lectures by international GMP-experts. In addition, regional supervisory authorities explain the local requirements for the entrepreneurs.

Projectinformation:

Target:
Organisation of a workshop: GMP-conform constructing
Projectarea:
East African Community (Burundi, Kenya, Ruanda, South Sudan, Tanzania, Uganda)
Term of validity:
Juni - September 2018
Projectvolume:
18.000 Euro
Sponsor:
PTB



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