Lymphohematopoietic cells for transplantation

1.1 This Standard addresses issues related to the safety of human allogeneic and autologous cells of lymphohematopoietic origin used for transplantation and includes quality system requirements. This Standard includes aspects of safety for potential and actual donors and recipients, personnel, and others who might be exposed to or affected by the transplant of lymphohematopoietic cells. The requirements of this Standard apply to lymphohematopoietic cells intended for homologous use (i.e., the cells perform the same basic function after transplantation). Notes: 1) In Canada, the use of lymphohematopoietic cells in non-homologous applications is subject to the Food and Drugs Act and applicable regulations. 2) This Standard provides minimum requirements for lymphohematopoietic cells for transplantation; however, they are the result of national, expert consensus and therefore might offer the benefit of globally recognized good practices for collection, processing, and distribution of other products used for cell therapies and regenerative medicine. CAN/CSA-Z900.1 and this Standard can be applied to other cellular therapy products outside the scope of these Standards as guidance and used as a starting point for establishments developing quality programs for novel cellular therapies. Other regulations can apply.

1.2 This Standard applies to establishments and individuals performing transplantation of lymphohematopoietic cells, and establishments and individuals involved in the following activities related to lymphohematopoietic cells intended for transplantation: a) processing (including donor screening, testing, and suitability assessment, and the collection of bone marrow, peripheral blood, or cord blood to be used for transplantation); b) evaluation of the safety of cells prior to transplantation; c) transplantation procedures; d) recordkeeping; e) error, accident, and adverse reaction investigation and reporting; f) distribution; g) importation or exportation; and h) complaints and recalls. Notes: 1) Examples of establishments include a) clinical transplant programs; b) collection facilities for lymphohematopoietic cells; and c) processing facilities for lymphohematopoietic cells. 2) The establishments listed in Items (a) to (c) of Note (1) can exist in the same geographical location or be physically separated and/or independently operated. This Standard is intended to serve as a benchmark and provide minimum requirements for the verification of safe practices in each of the activities listed in Items a) to h).

1.3 This Standard is not intended to replace detailed specifications and standard operating procedures, but is intended to be used in their preparation.

1.4 This Standard does not address the collection, processing, or administration of erythrocytes, mature granulocytes, platelets, plasma, or plasma-derived products intended for transfusion support.

1.5 This Standard contains particular requirements for lymphohematopoietic cells for transplantation and is intended to be used with CAN/CSA-Z900.1. Where differences exist, the requirements of this Standard apply.

1.6 In this Standard, “shall” is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; “should” is used to express a recommendation or that which is advised but not required; and “may” is used to express an option or that which is permissible within the limits of the standard. Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material. Notes to tables and figures are considered part of the table or figure and may be written as requirements. Annexes are designated normative (mandatory) or (non-mandatory) to define their application.