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23 April 2008

Draft Annex 13 Released: Section 44 Reworded to Enhance Understanding of the Two-Step Release Procedure

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 entr-gmp@ec.europa.eu and 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.

It is now more clearly defined that the sponsor should ensure that the details set out in the clinical trial application and considered by the Qualified Person are consistent with what is finally accepted by the competent authorities. Suitable arrangements to meet this requirement should be established. In practical terms, this can best be achieved through a change control process for the Product Specification File and defined in a Technical Agreement between the QP and the sponsor.

View the guideline
Annex 13 (Investigational Medicinal Products) for further information.

Compiled by:
Wolfgang Schmitt
On behalf of the European QP Association

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