| Nosaukums | <p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'Yu Mincho'; mso-fareast-theme-font: minor-fareast;">This document specifies requirements and gives guidance to suppliers and users of ancillary materials (AMs) to improve the consistency and quality of AMs of biological (human and animal) and chemical origin used in the production of cellular therapeutic products and gene therapy products for human use.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'Yu Mincho'; mso-fareast-theme-font: minor-fareast;">This document is applicable to materials that are used for cell processing and that come into contact with the active substance and that do not intentionally form part of the final cell and gene therapy product.</span></p>
<p class="Example" style="tab-stops: 19.85pt 39.7pt 59.55pt 67.7pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'Yu Mincho'; mso-fareast-theme-font: minor-fareast;">EXAMPLE 1<span style="mso-tab-count: 1;"> </span>Reagents, anticoagulants, cytokines, growth factors, enzymes, antibodies, serum (human or bovine), buffered solutions, culture media, dishes (coated with biological material), beads (coated with biological material), cryoprotectants (agents for cryopreservation), activation agents/reagents, non-mammalian cell (e.g. insect cell, bacterial cell), plasmid, viral vector.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'Yu Mincho'; mso-fareast-theme-font: minor-fareast;">This document does not apply to materials that are not used for cell processing, materials that do not come into contact with the active substance, or materials that intentionally form part of the final cell and gene therapy product.</span></p>
<p class="Example" style="tab-stops: 19.85pt 39.7pt 59.55pt 67.7pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'Yu Mincho'; mso-fareast-theme-font: minor-fareast;">EXAMPLE 2<span style="mso-tab-count: 1;"> </span>Cells that are either starting materials, intermediates or final form of a cellular therapeutic product, feeder cells, additives used post bioprocessing, scaffolds, non-biological consumables (e.g. beads, dishes, tissue culture flasks, bags, tubing, pipettes, needles), other plasticware that come into contact with the cell or tissue, apparatus, instruments.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'Yu Mincho'; mso-fareast-theme-font: minor-fareast;">A decision flowchart is given in </span><span class="citeapp"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">Annex A</span></span></span><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'Yu Mincho'; mso-fareast-theme-font: minor-fareast;">.</span></p>
<p class="Note" style="tab-stops: 19.85pt 39.7pt 48.25pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'Yu Mincho'; mso-fareast-theme-font: minor-fareast;">NOTE<span style="mso-tab-count: 1;"> </span>International, regional or national regulations or requirements can also apply to specific topics covered in this document.</span></p> |
|---|
| Darbības sfēra | <p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'Yu Mincho'; mso-fareast-theme-font: minor-fareast;">This document specifies requirements and gives guidance to suppliers and users of ancillary materials (AMs) to improve the consistency and quality of AMs of biological (human and animal) and chemical origin used in the production of cellular therapeutic products and gene therapy products for human use.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'Yu Mincho'; mso-fareast-theme-font: minor-fareast;">This document is applicable to materials that are used for cell processing and that come into contact with the active substance and that do not intentionally form part of the final cell and gene therapy product.</span></p>
<p class="Example" style="tab-stops: 19.85pt 39.7pt 59.55pt 67.7pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'Yu Mincho'; mso-fareast-theme-font: minor-fareast;">EXAMPLE 1<span style="mso-tab-count: 1;"> </span>Reagents, anticoagulants, cytokines, growth factors, enzymes, antibodies, serum (human or bovine), buffered solutions, culture media, dishes (coated with biological material), beads (coated with biological material), cryoprotectants (agents for cryopreservation), activation agents/reagents, non-mammalian cell (e.g. insect cell, bacterial cell), plasmid, viral vector.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'Yu Mincho'; mso-fareast-theme-font: minor-fareast;">This document does not apply to materials that are not used for cell processing, materials that do not come into contact with the active substance, or materials that intentionally form part of the final cell and gene therapy product.</span></p>
<p class="Example" style="tab-stops: 19.85pt 39.7pt 59.55pt 67.7pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'Yu Mincho'; mso-fareast-theme-font: minor-fareast;">EXAMPLE 2<span style="mso-tab-count: 1;"> </span>Cells that are either starting materials, intermediates or final form of a cellular therapeutic product, feeder cells, additives used post bioprocessing, scaffolds, non-biological consumables (e.g. beads, dishes, tissue culture flasks, bags, tubing, pipettes, needles), other plasticware that come into contact with the cell or tissue, apparatus, instruments.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'Yu Mincho'; mso-fareast-theme-font: minor-fareast;">A decision flowchart is given in </span><span class="citeapp"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">Annex A</span></span></span><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'Yu Mincho'; mso-fareast-theme-font: minor-fareast;">.</span></p>
<p class="Note" style="tab-stops: 19.85pt 39.7pt 48.25pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'Yu Mincho'; mso-fareast-theme-font: minor-fareast;">NOTE<span style="mso-tab-count: 1;"> </span>International, regional or national regulations or requirements can also apply to specific topics covered in this document.</span></p> |
|---|
