Retrieved V&A 2663/2014 December 16, 2014 # the determines are authorized the following variation: review of the production process of fraction II: from: temperature limit before separation of the fraction II: ≤ -6° C;
centrifuge outflow temperature limit during the separation of the fraction II: ≤ -5° C;
a: temperature limit before separation of the fraction II: between-8.5° C and-6.0° C;
centrifuge outflow temperature limit during the separation of the fraction II: between-8.5° C and-4.0° C;
sample application in process control 1a with a limit of 7.0-7.8 pH after resuspension of fraction II and sedimentation: from: production process at sites OPG-D Springe and OSA Lingolsheim: step 1: separation of II by centrifugation (OPG-D Springe and OSA) or alternatively by filtration with "Filter aid" (the ancillary materials filter) (OPG-D Springe);
a: OPG sites production process-D Springe and OSA Lingolsheim: step 1: separation of II by centrifugation or alternatively by filtration without "Filter aid" (the ancillary materials filter);
Elimination of optional phase adsorption of PPSB by using DEAE Sephadex in production site of OPG-D Springe;
submission of a post approval change management protocol for the use of the fraction II separated by filtration without "Filter aid» OPG-D site produced for the further production of Gamten at production sites of OPG Vienna (step2) and OAB Stockholm (step 3), concerning the medicine GAMTEN and authorised pack sizes the placing in Italy following the mutual recognition procedure.
How to: DE/H/0479/001/II/023/G.
Types of variation: 4. a) B "changes of in-process tests or limits applied during the manufacture of the active substance-strengthening limits applied during manufacture ';
B 2, c) "changes in the manufacturing process of the active ingredient-The amendment concerns a biological/immunological substance or use of a substance derived chemically different in manufacture of a biological/immunological substance, that have a significant impact on the quality, safety and efficacy of the medicinal product and which is not linked to a protocol ';
BI. a. 2) "changes in the manufacturing process of the active substance-minor changes in the manufacturing process of the active ingredient ';
B. i.e. 2) ' introduction of a post approval change management protocol on the active ingredient '.
A.I.C. holder: Octapharma Italy S.p.a.
Inventory disposal lots already products can be kept on the market until the expiration date printed on the label of the medicinal product in accordance with art. 1, paragraph 5 of the April 14, 2014 # 371 determines AIFA published in Official Gazette No 101 of May 3, 2014.
Date of determination: this determination is effective on the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana and company will be notified to the holder of the marketing authorisation for the medicinal product.