Eudralex

All posts tagged Eudralex

2016-03-30_08-03-13

The latest version of the Eudralex Volume 4, Good manufacturing practice (GMP) Guidelines can be found at this link:

http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm

It’s well worth having a look at to see how GMP documents, such as the site master file, can be laid out.

The EudraLex V29  September 2014 has just been release. It is a substantial document but if you wanted to have a look at it you can download it from the link below. Warning the file size is 910mbs so it’s very large and will take a while to download on a slow connection.

http://ec.europa.eu/health/documents/eudralex/cd/index_en.htm

For individual sections of the Eudralex you can have a look at this link:

http://ec.europa.eu/health/documents/eudralex/index_en.htm

The link below is to the Documentation section (Chapter 4) of the EudraLex Guide: The Rules Governing Medicinal Products in the European Union.

http://ec.europa.eu/health/files/eudralex/vol-4/chapter4_01-2011_en.pdf

 

The documents below out line the Eudralex and FDA GMP guidelines for dealing with complaints and product recalls.

Eudralex Guide to Complaints Product Recall

FDA Guide to Complaints and Product Recall