Source Plasma definition

Source Plasma means Plasma collected by apheresis;
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Source Plasma means the fluid portion of human blood col- lected and intended as source material for further manufacturing use. The definition excludes single donor plasma products intended for in- travenous use.
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Source Plasma means plasma that is collected by plasmapheresis and that is used in the manufacture of a drug for human use.
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Examples of Source Plasma in a sentence

  • The suit- ability of a donor for Source Plasma shall be determined by a qualified li- censed physician or by persons under his supervision and trained in deter- mining donor suitability.

  • All administration and transfer sets inserted into blood containers used for processing Source Plasma intended for manufacturing into injectable or noninjectable prod- ucts and all interior surfaces of plasma containers used for processing Source Plasma intended for manufacturing into injectable products shall be ster- ile, pyrogen-free, nontoxic, and com- patible with the contents under normal conditions of use.

  • Source Plasma shall not contain a preservative.[38 FR 32089, Nov.

  • All blood for the col- lection of Source Plasma shall be drawn from the donor by a qualified li- censed physician or by persons under his supervision trained in the proce- dure.

  • If Source Plasma is re- quired to be relabeled as ‘‘Source Plas- ma Salvaged’’ under paragraph (a)(1) or(b) of this section, the person respon- sible for the relabeling shall cover the original label with either (1) a com- plete new label containing the appro- priate information or (2) a partial label affixed to the original label and con- taining the appropriate new informa- tion, which covers the incorrect infor- mation regarding storage temperature.[45 FR 80501, Dec.

  • Final containers used for Source Plasma, whether inte- grally attached or separated from the original blood container, shall not be entered prior to issuance for any pur- pose except for filling with the plasma.

  • If Source Plasma for manufacture into injectable products is exposed inadvertently (i.e., an unforeseen occurrence in spite of compliance with good manufacturing practice) to a shipping temperature warmer than ¥5 °C and colder than +10°C, the plasma derivative manufacturer shall label it ‘‘Source Plasma Salvaged.’’ Appropriate records shall be maintained identifying the units in- volved, describing their disposition, and explaining fully the conditions that caused the inadvertent tempera- ture exposure.

  • Plasma intended for manufacturing into noninjectable products may be stored at tempera- tures appropriate for the intended use of the final product, provided these temperatures are included in the Source Plasma license application.

  • The source mate- rial of Albumin (Human) shall be plas- ma recovered from Whole Blood pre- pared as prescribed in §§ 640.1 through 640.5, or Source Plasma prepared as prescribed in §§ 640.60 through 640.76.

  • For the purposes of this document, “blood and plasma establishment” includes licensed manufacturers of blood and blood components, including Source Plasma, unlicensed registered blood establishments, and transfusion services.


More Definitions of Source Plasma

Source Plasma means CMV Hyper-Immune source plasma to be delivered to Prothya, by or on behalf of Kamada or CSL in accordance with the terms set forth in the SOW and the Plasma Agreement, for the performance by Xxxxxxx of the Services.
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Source Plasma as defined by the regulations of the Center for Biologics Evaluation and Review of the Food and Drug Administration ("FDA") and/or other applicable international, state or local authorities now or hereafter in effect (the "Regulations"), that meets the product specifications as set forth on Exhibit A, as the same may be amended from time to time (the "Specifications"), and has levels of both S. aureus and S. epidermidis antibodies satisfactory to Inhibitex in its sole discretion.
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Source Plasma means the fluid portion of human blood col­ lected and intended as source material for further manufacturing use.
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Source Plasma means the human anti-rabies plasma supplied by Sanofi Pasteur to BPC under the terms of this Agreement pursuant to the terms of a separate source plasma supply agreement between the parties or otherwise provided from external sources.
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Source Plasma means human plasma collected by plasmapheresis that is intended for use in producing a drug for human use. (plasma destiné au fractionnement)
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