Based on practical experiences a revision of the Annex 13 (Investigational
Medicinal Products) was deemed necessary to clarify certain points related to
reference and retention samples, the two-step release procedure for
investigational medicinal products and to the principle of independence between
production and quality control functions.
Comments should be sent to
GMP@emea.europa.eu by 31 October 2008.
The following changes are proposed for Annex 13:
- A minor change has been made to section 3 in order to reinforce
the principle of independence between production and quality control functions
in cases where the number of personnel involved is small.
- Changes are proposed to sections 36 and 37 to supplement, for
investigational medicinal products, the guidance for reference and retention
samples given in Annex 19.
- Section 44 has been reworded to enhance understanding of the
two-step release procedure that applies to investigational medicinal products.
You can find the document here:
On behalf of the European Compliance Academy (ECA)