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Guideline

The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.

Annex 1: Manufacture of Sterile Medicinal Products - revision November 2008
Short Title:Annex 1
Internet:http://ec.europa.eu/health/files/eudralex/vol-4/2008_11_25_gmp-an1_en.pdf
Origin/Publisher:European Commission - Enterprise and Industry Directorate General - Consumer goods - Pharmaceuticals - Deutschsprachige Version: http://www.bmg.bund.de/fileadmin/redaktion/pdf_gesetze/bekanntmachungen/Anhang-1-GMP-Leitfaden.pdf
Content:Supplementary guidelines to the EC-GMP Guide with specific requirements for the manufacture of sterile medicinal products.
Document Type:EC GMP Guide