20/21 November 2019
The introduction of a EU Site Master File (Part III of the EU GMP Guide) has significantly changed the requirements on the creation of a company description (see our GMP News from 10 February 2011). The very precise instructions (partly with indication of the number of words) have all disappeared. New requirements have been added. The importance of suppliers' qualification (up to supply chain integrity) is much higher than in the past. Transport validation has become a new key topic. Nevertheless, many SMFs are still available in the older version. The lack of detailed information - unlike earlier times - makes the change to the new version difficult. Yet, a sample documentation - elaborated by export from diverse pharmaceutical companies - provides support. The bilingual BAH brochure (German/English) describes a SMF according to the requirements laid down in Part III of the EU GMP Guide.
Participants of the ECA Webinar "How to handle the new Site Master File" on 3 June 2013 will get the brochure as free add-on as well as a Site Master File Matrix which presents a step-by-step comparison of the older and the new Site Master File.