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.

Eudralex Volume 3 Annexes to: CPMP/ICH/283/95 Impurities: Guideline for Residual Solvents & CVMP/VICH/502/99 Guideline on Impurities: Residual Solvents; ANNEX I: SPECIFICATIONS FOR CLASS 1 AND CLASS 2 RESIDUAL SOLVENTS IN ACTIVE SUBSTANCES; ANNEX II: RESI

Short Title:
CPMP/QWP/450/03 -Rev.1, EMEA/CVMP/511/03 -Rev.1

EMA 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK

Document Type:
These two Annexes specify class 1 and class 2 residual solvents and provide guidance for the use of organic solvents in the manufacture of medicinal products.

Go back

GMP Conferences by Topics