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GCP and Guideline Updates |
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Date: 22/02/2010 |
| Type: Guideline |
| Region: Europe |
Subject: New Version of Annexe 13
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| The EMEA has finally issued the updated version of Annexe 13 (manufacturing requirements for Investigational Medicinal Product). Key changes are:
1. Clarification of what is meant by "reconstitution" under the QP exemption provision:
Reconstitution is:
dissolving or dispersing the investigational medicinal product for administration of the product to a trial subject,
diluting or mixing the investigational medicinal product(s) with some other substance(s) used as a vehicle for the purposes of administering it
Reconstitution is not mixing several ingredients
Process to be defined CTA and protocol
2. Clarification of the requirements for retention of samples, both reference (for analysis) and retention (for identification) samples
3. Inclusion of a standard format for QP release certificates.
Deadline for implementation is 31 July 2010 and you can find it here: http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-4/2009_06_annex13.pdf
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