# Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, Division 3.3.2.2: Manufacturing process

Extent: E+W+S+N.I.

(a) The manufacturing process shall be validated to ensure batch and process consistency, functional integrity of the cells throughout manufacturing and transport up to the moment of application or administration, and proper differentiation state.
(b) If cells are grown directly inside or on a matrix, scaffold or device, information shall be provided on the validation of the cell culture process with respect to cell-growth, function and integrity of the combination.

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/IV/division/3/division/3.3/division/3.3.2/division/3.3.2.2 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-IV/division-3/division-3.3/division-3.3.2/division-3.3.2.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.