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Projekta Nr. ISO 20404:2023 Nosaukums <p class="MsoBodyText" style="line-height: 12.0pt; mso-line-height-rule: exactly; tab-stops: 19.85pt 22.2pt 39.7pt 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: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">This document specifies general requirements and considerations for the design of packaging used to contain cells for therapeutic use.</span></p>
<p class="MsoBodyText" style="line-height: 12.0pt; mso-line-height-rule: exactly; tab-stops: 19.85pt 22.2pt 39.7pt 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: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">This document is applicable to packaging intended to contain the final products of cells for therapeutic use, as well as their starting and intermediate materials.</span></p>
<p class="MsoBodyText" style="line-height: 12.0pt; mso-line-height-rule: exactly; tab-stops: 19.85pt 22.2pt 39.7pt 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: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">This document does not apply to:</span></p>
<p class="ListNumber1" style="tab-stops: 19.85pt 39.7pt 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: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">a)<span style="mso-tab-count: 1;"> </span>receptacles used for processing cells in manufacturing processes, e.g. cell culture flask or bag;</span></p>
<p class="ListNumber1" style="line-height: 12.0pt; mso-line-height-rule: exactly; tab-stops: 19.85pt 22.2pt 39.7pt 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: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">b)<span style="mso-tab-count: 1;"> </span>shipping containers containing packages for transportation;</span></p>
<p class="ListNumber1" style="line-height: 12.0pt; mso-line-height-rule: exactly; tab-stops: 19.85pt 22.2pt 39.7pt 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: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">c)<span style="mso-tab-count: 1;"> </span>services that utilize packages, e.g. storage services.</span></p>
<p class="Note" style="line-height: 12.0pt; tab-stops: 19.85pt 22.2pt 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: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">NOTE 1<span style="mso-tab-count: 1;"> </span>Examples of packaging, packages and shipping containers are illustrated 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: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">.</span></p>
<p class="Note" style="line-height: 12.0pt; tab-stops: 19.85pt 22.2pt 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: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">NOTE 2<span style="mso-tab-count: 1;"> </span>The design of packaging includes processes to ensure that the designed packaging is manufactured to a required specification through trial manufacturing, testing and implementation of quality management.</span></p>
<p class="Note" style="line-height: 12.0pt; tab-stops: 19.85pt 22.2pt 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: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">NOTE 3<span style="mso-tab-count: 1;"> </span>International, national or regional regulations or requirements can also apply to specific topics covered in this document.</span></p> Reģistrācijas numurs (WIID) 81477 Darbības sfēra <p class="MsoBodyText" style="line-height: 12.0pt; mso-line-height-rule: exactly; tab-stops: 19.85pt 22.2pt 39.7pt 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: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">This document specifies general requirements and considerations for the design of packaging used to contain cells for therapeutic use.</span></p>
<p class="MsoBodyText" style="line-height: 12.0pt; mso-line-height-rule: exactly; tab-stops: 19.85pt 22.2pt 39.7pt 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: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">This document is applicable to packaging intended to contain the final products of cells for therapeutic use, as well as their starting and intermediate materials.</span></p>
<p class="MsoBodyText" style="line-height: 12.0pt; mso-line-height-rule: exactly; tab-stops: 19.85pt 22.2pt 39.7pt 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: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">This document does not apply to:</span></p>
<p class="ListNumber1" style="tab-stops: 19.85pt 39.7pt 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: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">a)<span style="mso-tab-count: 1;"> </span>receptacles used for processing cells in manufacturing processes, e.g. cell culture flask or bag;</span></p>
<p class="ListNumber1" style="line-height: 12.0pt; mso-line-height-rule: exactly; tab-stops: 19.85pt 22.2pt 39.7pt 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: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">b)<span style="mso-tab-count: 1;"> </span>shipping containers containing packages for transportation;</span></p>
<p class="ListNumber1" style="line-height: 12.0pt; mso-line-height-rule: exactly; tab-stops: 19.85pt 22.2pt 39.7pt 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: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">c)<span style="mso-tab-count: 1;"> </span>services that utilize packages, e.g. storage services.</span></p>
<p class="Note" style="line-height: 12.0pt; tab-stops: 19.85pt 22.2pt 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: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">NOTE 1<span style="mso-tab-count: 1;"> </span>Examples of packaging, packages and shipping containers are illustrated 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: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">.</span></p>
<p class="Note" style="line-height: 12.0pt; tab-stops: 19.85pt 22.2pt 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: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">NOTE 2<span style="mso-tab-count: 1;"> </span>The design of packaging includes processes to ensure that the designed packaging is manufactured to a required specification through trial manufacturing, testing and implementation of quality management.</span></p>
<p class="Note" style="line-height: 12.0pt; tab-stops: 19.85pt 22.2pt 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: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">NOTE 3<span style="mso-tab-count: 1;"> </span>International, national or regional regulations or requirements can also apply to specific topics covered in this document.</span></p> Statuss Standarts spēkā ICS grupa 07.080
