Glossary
Glossary
Active Labor: A period characterized by regular painful uterine contractions, a substantial degree of cervical effacement, and more rapid cervical dilatation from 5 cm until full dilatation for first and subsequent labors.
Administration: With respect to cellular therapy products, the act of delivering the product into a recipient, including, but not limited to, infusion, transplantation, implantation, or injection.
Adverse Event: A complication. Adverse events may occur in relation to organization-defined activities.
Advocacy: A service whereby an impartial individual or a team who has/have working knowledge of cellular therapy and whose interest is centered on the well-being of the subject speaks on the subject’s behalf. The subject could be a donor or recipient. The service helps
the subject understand the process, procedures, and potential risks or benefits.
Agreement: A contract, order, or understanding between two or more parties, such as between an organization and one of its customers.
Agreement Review: Systematic activities carried out before finalizing the agreement to ensure that requirements are adequately defined, free from ambiguity, documented, and achievable.
Allogeneic Donor: An individual from whom cellular therapy products intended for another person are procured. This individual may or may not be genetically related to the recipient.
Analyte: Substance or chemical constituent that is assayed.
Aseptic Methods: Methods designed to eliminate the risk of microbial contamination to a product, reagent, sample, or person in a laboratory or clinical-care setting.
Assessment: A systematic examination to determine whether actual activities comply with planned activities, are implemented effectively, and achieve objectives. Types of assessments include external assessments, internal assessments, peer review, and self-assessments.
Attributes: Additional characteristics that uniquely define a cellular therapy product.
Authorization (in relation to procurement from cadaveric donors): A legal record providing permission for postmortem recovery of cells/tissues and subsequent use.
Autologous Donor: A person who acts as his or her own cellular therapy product donor.
Available for Distribution: The determination that a product has met all relevant requirements (eg, donor eligibility, product processing, etc) and can be issued for clinical use.
Backup: Digital data and/or physical storage containing copies of relevant data.
Bacteremia: Systemic inflammatory response due to an infectious agent and accompanied by characteristic clinical and laboratory findings.
Bioassay: A measurement of the concentration or potency of a substance by its effect on living cells or tissues.
Biologic Agent: A protein-based substance that is made from a living organism or its products and is used in the prevention, diagnosis, or treatment of cancer and other diseases. Biologic agents include antibodies, interleukins, and vaccines.
Biologic Mother: The female who is the source of the ovum.
Birth Mother: The female carrying the fetus to term.
By-Products: Portions of the original cellular therapy product retained for nonclinical use. Examples include cell fractions and removed plasma.
Cadaveric Donor: A deceased donor from whom cellular therapy products or organs are procured. If donation occurs following cardiac death, infectious disease testing must be performed using test kits that are specifically cleared or approved for use in cadaveric donors.
Calibrate: To set or align measurement equipment against a known standard.
Cellular Starting Material (CSM): Initial or raw biological material from cells, tissue, or organs that may be further manipulated through various techniques such as processing, selection, expansion, gene editing, and other combinations of engineering for therapeutic benefit.
Cellular Therapy Product: Cell-based products that may be minimally or more-than-minimally manipulated, including cellular immunotherapies, regenerative medicines, and other types of autologous and allogeneic tissues or cells.
Certified by Centers for Medicare and Medicaid Services (CMS): Having met the requirements of the Clinical Laboratory Improvement Amendments of 1988 through inspection by the CMS, a deemed organization, or an exempt state agency.
Chain of Custody (COC): Concurrent, permanent, auditable documentation illustrating the guardianship of a cell or gene therapy product from its origin through its final disposition.
Chain of Identity (COI): The permanent and transparent association of a cell or gene therapy’s unique identifiers from procurement of tissue or cells throughout the full product(s) lifecycle, including posttreatment monitoring.
Change Control: A structured method of revising a policy, process, or procedure, including hardware or software design, transition planning, and revisions to all related documents.
Characterization: A cell’s identity by the expression, or activity, of certain genes in its DNA and the resulting production of particular proteins.
Clinical Activities: The tasks performed by integrated patient care teams linked by a uniform quality management system and reflected in the organizational structure.
Clinical Facility: The facility(ies) responsible for the administration of the product and related patient-care activities.
Clinical Program Director: A qualified physician who is board certified and licensed to practice medicine in at least one specialty or subspecialty and who is responsible for all aspects of the clinical program.
Combined Cellular Products: Products that come from two or more different cell sources.
Competence: An individual’s demonstrated ability to apply knowledge and skills needed to perform their job tasks and responsibilities.
Competent Authority: The agency responsible under its national law for regulations applicable to the organization.
Completion of Processing: The point in processing at which no further actions are required to be taken in connection with a cellular therapy product before it is placed into storage.
Compliance: See Conformance.
Confidentiality: The protection of private, sensitive, or trusted information resources from unauthorized access or disclosure.
Conformance: Fulfillment of requirements. Requirements may be defined by customers, practice standards, regulatory agencies, or law.
Consenter(s): Individual(s) whose consent is obtained for the procurement of cellular therapy products. For cord blood or gestational material procurement, this may include, but is not limited to, the neonatal donor’s birth mother, biologic mother, surrogate mother, and any legal custodians (when applicable). For cadaveric donors, this may include the donor, the donor’s next of kin, or a legally authorized representative.
Contamination: Introduction of unwanted chemical or biological matter from the environment or from another cellular therapy product.
Continuous Monitoring: A mechanism that allows for surveillance of a process or system intended to ensure proper operation and the detection of control exceptions.
Controlled-Rate Freezing: A procedure using a device to control the temperature of a product during the freezing process.
Cord Blood: The portion of the blood of a fetus or neonate that remains in the placenta or umbilical cord following delivery of the neonate and clamping of the umbilical cord. Umbilical cord blood is typically rich in hematopoietic progenitor cells.
Cord Blood Donor: The neonate who is the source of a cellular therapy product.
Corrective Action: Actions taken to address the root cause(s) of an existing nonconformance or other undesirable situation in order to reduce or eliminate recurrence.
Critical Equipment/Materials/Tasks: A piece of equipment, material, service, or task that can affect the quality of the organization’s products or services.
Cryopreservation: The process of low-temperature freezing and storage of cellular therapy products in order to preserve cells that, after thawing, retain a significant measure of their prefreeze viability and function.
Cryoprotectant: A solution or additive that, when combined with living cells, provides protection from damage otherwise induced by the freezing and/or thawing process.
Cultured Cells: Cells that are expanded and/or differentiated in vitro in media requiring monitoring of gas levels, temperature, humidity, and sterility.
Customer: The recipient of a product or service. A customer may be internal (eg, another organizational unit within the same organization) or external (eg, a patient, client, donor, or another organization).
Data Integrity: The accuracy, completeness, and consistency of information.
Designee: An individual with appropriate experience or expertise who is given the authority to assume a specific responsibility.
Deviation: A departure from policies, processes, procedures, applicable regulations, standards, or specifications.
Disaster: An event (internal, local, or national) that can affect the safety and availability of the organization’s products or the safety of individuals.
Disposition: For cellular therapy products, the status or control of a cellular therapy product in a given facility. For records, disposition occurs at the end of their retention period.
Distribution: The act of releasing a finished cellular therapy product for human use.
Document (noun): Written or electronically generated information and work instructions. Examples of documents include quality manuals, procedures, or forms.
Document (verb): To capture information through writing or electronic media.
Donation Identification Number (DIN): A 13-character code that identifies products from a single donation event that allows each event to be uniquely identified. The DIN contains three elements: the five character alphanumeric facility identification number (FIN), the two character numeric DIN year code, and the six-character numeric DIN sequence number.
Donor: A living or deceased person who is the source of a cellular therapy product.
Donor Screening: The process of identifying risk factors for relevant communicable disease through review of a current donor medical history interview (to include high-risk behaviors), physical examination results, and other relevant medical records.
Educational and Promotional Materials: Information made available by the cellular therapy facility to potential donors, patients, and others, including, but not limited to, therapeutic benefit claims on the facility’s website, in facility information, in advertisements, in marketing materials, and in enrollment documents, and information provided by the facility to the media that explains the procurement, processing, use, and benefits of the donation, as well as alternatives to the donation of the product.
Eligibility: With respect to cellular therapy donors, the evaluation for risk factors for, and clinical evidence of, relevant infectious disease agents or diseases for the purpose of preventing the introduction, transmission, and spread of infectious disease. A donor may be found to be eligible or ineligible (see Ineligible Donor). Alternatively, the determination may be incomplete (eg, screening is incomplete or donor testing is not performed in a time frame specified by the test kit manufacturer’s instructions).
Emergency Management: Strategies and specific activities designed to manage situations in which there is a significant disruption to organization operations or a significantly increased demand for the organization’s products or services.
Engraftment: The reconstitution of recipient hematopoiesis with white cells, red cells, and platelets from the donor. Engraftment of other types of cells generally will be shown by evidence of graft function specific to the organ of engraftment.
Environmental Monitoring: Policies, processes, and procedures used for monitoring any or all of the following: temperature, humidity, particulates, and microbial contamination in a specific area. Where appropriate, the program shall include identification of sampling sites,
frequency of sampling, and investigative and corrective actions that should be followed when specified limits are exceeded.
Equipment: A durable item, instrument, or device used in a process or procedure.
Establish: To perform all of the activities required to plan, validate, and implement a system or process.
Exception: An action or condition that is not part of normal operations.
Executive Management: The highest-level personnel within an organization, including employees, clinical leaders, and independent contractors, who have responsibility for the operations of the organization and who have the authority to establish or change the organization’s quality policy. Executive management may be an individual or a group of individuals.
Facility: A location or operational area within an organization. The part of the organization that is assessed by the AABB and receives AABB accreditation for its specific activities.
Final Cellular Therapy Product: A cellular therapy product that is ready for issue or final distribution.
Final Disposition: The terminal status of the product after which no further action can be taken (eg, discard or infusion).
Final Inspection and Testing: An activity (such as measuring, examining, or testing one or more characteristics of a product or service) that compares the results with specified requirements in order to establish whether conformance is achieved for each characteristic.
Function: The special, normal, or proper physiologic activity of a cellular therapy product that can be qualitatively or quantitatively evaluated (eg, by in-vitro or in-vivo assays).
Gestational Materials: Any tissue procured at or near the time of birth (eg, umbilical cord tissue, placental tissue, amniotic fluid).
Growth Factors: Recombinant cytokines that promote proliferation and/or differentiation of specific cell types or lineages. Certain growth factors can be used in vivo (eg, mobilization of hematopoietic progenitor cells) or ex vivo (eg, cell expansion, vaccine development, and adoptive cellular therapy).
Handling: The various operations involved in the preparation, processing, and movement of materials and products. This includes actions such as receiving, transporting, unpacking, sorting, and preparing items for manufacturing or further distribution.
Health-Care Professional: An individual employed by a facility qualified by education, training, and experience to perform the duties assigned.
Hematopoietic Progenitor Cells (HPCs): Primitive pluripotent hematopoietic cells capable of self-renewal and/or differentiation as well as maturation into any of the hematopoietic lineages (granulocytes, monocytes, erythrocytes, and platelets), including committed and lineage-restricted progenitor cells, unless otherwise specified, regardless of source (eg, marrow, mobilized peripheral blood, or umbilical cord blood).
Human Subject Research: Refers to any study, investigation, or experiment that involves the collection, use, analysis, or dissemination of data obtained from living individuals.
Identity: A set of factors that distinguishes one product from another. For cellular therapy products, identity is often stated in terms of specific positive and negative markers expressed by the cells.
In-House Reagents: See Reagent.
In-Process Label: A label used to identify a cellular therapy product at any intermediate processing step when a full label cannot be used due to space or size limitations.
In Vitro: Observable in an artificial environment.
In Vivo: Within the living body.
Incoming Materials: Materials at the time of receipt into a facility.
Independent Ethics Committee: An independent body (for example, a review board or committee that is either institutional, regional, national, or supranational) consisting of medical professionals and nonmedical members. The group is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection by reviewing and approving and/or providing professional opinion on a trial protocol, including the suitability of investigator(s), facilities, and the methods and materials used in recruiting participants and obtaining and documenting informed consent of the trial subjects. The legal status, composition, function, operations, and regulatory requirements pertaining to independent ethics committees may differ between
countries, but the independent ethics committee should promote good clinical practice.
Ineligible Donor: A designation applied to a donor whose product may be at risk of transmitting an infectious disease as detected by testing and/or by donor screening history.
Inner Shipping Container: A box, container, or bag that holds a labeled product during shipping inside an outer shipping container.
Inspect: To measure, examine, or test one or more characteristics of a product or service and compare results with specific requirements.
Installation Qualification: Verification that the correct equipment is received and that it is installed according to specifications and the manufacturer’s recommendations in an environment suitable for its operation and use.
Intermediate Facility: Any facility other than the procurement facility and administering facility that manipulates or performs any activity covered by these CT Standards.
Investigational New Drug (IND): An investigational drug or biological product administered to humans under a protocol or research program authorized by the Competent Authority.
Investigator’s Brochure: A compilation of clinical and nonclinical data about the investigational cellular therapy product(s) used in research of human subjects. It describes the product’s formulation and effects, including information related to safety, effectiveness, risk of adverse events, and monitoring relevant to the investigational product.
Islets: A cellular therapy product consisting of partially purified pancreatic islets of Langerhans. Insulin-producing beta cells within such islets make up the functional component of the product.
Issue: To release a final cellular therapy product for clinical use (eg, physical transfer of the cellular therapy product to the medical service responsible for administering the product to the patient by infusion, injection, or other method).
Issuing Facility: The facility that issues the cellular therapy product for clinical use.
Key Quality Functions: Essential job functions that affect the services provided by the organization.
Label: An inscription affixed or attached to a product for identification.
Label (Accompanying): Product information that is available with the product or is available electronically.
Label (Affixed): A label that is in physical contact with the container.
Label (Attached): A label that is securely fastened to the product container by means of a tie-tag or alternative method.
Labeling: Information that is required or selected to accompany the product, which may include content, identification, description of processes, storage requirements, expiration date, cautionary statements, or indications for use.
Laboratory Attire: Attire worn in the laboratory as protection against contamination of the person or of the product. This may include gloves, laboratory coats, hair covers, face covers, shoe covers, and sterile sleeves.
Laboratory Director: A qualified individual holding a relevant doctoral degree who is responsible for all technical aspects of the cellular therapy product service.
Laboratory Medical Director: A qualified licensed physician who has overall responsibility and authority for all medical aspects of the cellular therapy product service.
Legal Custodian: A person legally responsible for the donor until the donor’s age of majority.
Leukocyte-Rich Products: Leukocyte-rich products are defined at the time of collection/procurement, even if later processing might remove leukocytes. Some examples of leukocyte-rich products include, but are not limited to, hematopoietic stem and progenitor cells such as apheresis products, marrow, umbilical/placental cord blood or gestational
materials, and nucleated cell preparations such as mononuclear cells collected by apheresis (MNC, Apheresis). Some organs and tissues can be leukocyte-rich.
Life-Cycle Requirements: The stages and time span from initial planning of an information system software program to its retirement; that is, from concept, to software development, to business changes, to revisions, to retirement.
Look-Back: The process of reviewing and, if necessary, removing from inventory any product that is potentially infectious or nonconforming.
Maintain: To keep in the current state; to preserve or retain; to keep in a state of validity.
Manufacture: All steps in the preparation and testing of a cellular therapy product, from donor evaluation to making the product available for distribution.
Master List of Documents: A reference list, record, or repository of an organization’s policies, processes, procedures, forms, and labels related to the CT Standards, including information for document control.
Material: A supply item used in a process or procedure.
Medical Suitability: Evaluation of cellular therapy donors for risks related to the donation process and potential noninfectious risks to the recipient.
Medical Therapy: The direct provision of a medical intervention ordered by a physician (eg, harvest of hematopoietic progenitor cells by apheresis for reinfusion to the autologous donor/patient, administration of a pharmaceutical agent to a patient, or administration of a
cellular therapy product).
Mesenchymal Stem Cells: A cellular therapeutic product defined as multipotent cells with the ability to differentiate into nonhematopoietic tissues of mesodermal origin.
Mononuclear Cells (MNCs): Lymphocytes and monocytes in the collected product.
Myeloablative Therapy: Treatment of a patient with an agent (eg, chemotherapy or gamma irradiation) that causes irreversible marrow aplasia.
Near-Miss Event: An unexpected occurrence that did not adversely affect the outcome but could have resulted in a serious adverse event.
Noncompetent: With respect to donors, an individual who lacks the legal ability to make medical decisions for himself/herself.
Nonconformance: Failure to meet requirements.
Nonconforming Product or Service: A product or service that does not satisfy one or more specified requirements.
Novel Method: An innovative method or procedure being evaluated and introduced into practice at a facility. The method may not have undergone internal or external peer review or approval by an independent ethics committee.
Off-Site Location: A physical storage facility or electronically supported storage medium that provides reliable redundancy of data.
Operational Qualification: Verification that equipment will function according to the operational specifications provided by the manufacturer.
Operational Systems: Processes, resources, and activities that work together to result in a product or service.
Organization: An institution, or a location or operational area within that organization; the entity assessed by the AABB and receiving AABB accreditation for specific activities.
Outer Shipping Container: A container made of material adequate to withstand leakage of contents, impact shocks, pressure changes, temperature changes, puncture, and other conditions incident to ordinary handling.
Output: The product, information, or service that results from performing a process or procedure.
Parties: Entities or individuals who have entered into an agreement.
Patient: An individual undergoing medical care. The individual may also be a research subject.
Patient-Specific Product: A product collected and/or prepared exclusively for a particular autologous or allogeneic recipient.
Performance Qualification: Verification that equipment performs consistently as expected for its intended use in the organization’s environment, using the organization’s procedures and supplies.
Policy: A set of basic principles or guidelines that direct or restrict the organization’s plans, actions, and decisions.
Potency: The therapeutic activity of a product as indicated by appropriate laboratory tests or adequately developed or controlled clinical data.
Preparation for Administration: The preparation of a distributed cellular therapy product for administration. Preparation steps typically are minimal and occur immediately before a product is issued for administration.
Preparative Regimen: Any regimen of immunosuppressive and/or myelosuppressive chemotherapeutic agents and/or radiation therapy that is given to prepare the recipient before the administration of a cellular therapy product.
Preventive Action: An action taken to reduce or eliminate the potential for unexpected deviations, nonconformances, or other undesirable situations.
Procedure: A defined series of tasks and instructions that specify how an activity is to be performed.
Process: A set of related activities that transform inputs into outputs.
Process Control: Activities designed to ensure that processes are stable and consistently operate within acceptable limits of variation in order to produce predictable output that meets specifications.
Processing: Any activity performed on a cellular therapy product, other than recovery, donor screening, donor testing, storage, labeling, packaging, or distribution. Such processing activities include testing for microorganisms, preparation, sterilization, steps to inactivate or
remove adventitious agents, preservation for storage, and removal from storage.
Processing Facility: The facility involved in receipt of the product from the procurement facility. The processing facility may perform further manufacturing, testing, and/or distribution of the product.
Procurement: The act of obtaining a cellular therapy product(s) or cellular starting material from a donor by facility-approved methods, including, but not limited to, apheresis, marrow harvest, cord blood or gestational material collection, or organ or tissue harvesting from a
donor.
Procurement-Associated Intervention: Any event intended to assist with the procurement of a cellular therapy product, such as medications given to mobilize cells, placement of a line for easier access, etc.
Procurement Container: Any receptacle suitable for the procurement of a specific product.
Procurement Facility: Either a facility that is directly responsible for the performance of donor eligibility determination, donor screening, and the procurement of cellular therapy products or a facility that ensures, through agreements, that one or more of these activities is/
are performed in conformance with these CT Standards.
Procurement Goal: The desired outcome of the procurement process.
Product: A tangible output from a process.
Product Code: An eight-character ISBT 128 code composed of the five-character product description code, the one-character collection type code, and the two-character division code.
Proficiency Testing: The structured external evaluation of laboratory methods that assesses the performance of the test system.
Protected Health Information (PHI): Individually identifiable health information that can be linked to a particular person that is related to physical or mental health status, the type of health-care provided, or payment for the health-care provided. Common identifiers of health
information include names, social security numbers, addresses, and birth dates. PHI can be in electronic, oral, or written format.
Purity: Dominance of a targeted cellular population defined by specific cell markers and with minimal to no contamination of cells negative for the same markers.
Qualification (equipment or suppliers): Verification that specified attributes required to accomplish the desired task have been met.
Qualification (individuals): The aspects of an individual’s education, training, and experience that are necessary for the individual to successfully meet the requirements of a position.
Qualification (materials): For materials that come into contact with the product, verification that the materials are sterile, the appropriate grade and suitability for the intended use, and, whenever possible, approved for human use by the US FDA or relevant Competent
Authority.
Quality: Characteristics of a product or service that bear on its ability to fulfill customer expectations. The measurable or verifiable aspects of a product or service that can be used to determine if requirements have been met.
Quality Control: Testing routinely performed on materials and equipment to ensure their proper function.
Quality Indicator Data: Information that may be collected and used to determine whether an organization is meeting its quality objectives as defined by executive management in its quality policy. Indicators are measured by data for movement or regression with regard to those quality intentions. The data used for monitoring a quality indicator may consist of single-source data or multiple-source data, as long as it is clear how the data will come together to define the indicator.
Quality Management System: The organizational structure, responsibilities, policies, processes, procedures, and resources established by executive management to achieve quality.
Quality Manual: A document that describes a facility’s quality system.
Quality Policy: The overall vision, intentions, and direction of an organization to achieve quality, formally expressed by executive management.
Quarantine: Storage of cellular therapy products, reagents, or materials, in order to prevent improper release and/or cross-contamination, either in a physically separate area clearly identified for such use, or by identification of a product through the use of other procedures, including automated designation, for the same purpose.
Reagent: A substance used to perform an analytical or manufacturing procedure. A substance used (as in detecting or measuring a component or preparing a product) because of its biological or chemical activity. Reagents can be either purchased ready for use or prepared within the facility (in-house).
Receiving Facility: A facility receiving products or services.
Recipient: The patient receiving a cellular therapy product.
Record (noun): Information captured in writing or through electronically generated media that provides objective evidence of activities that have been performed or results that have been achieved, such as test records or audit results. Records do not exist until the activity has been performed and documented.
Record (verb): To capture information for use in records through writing or electronic media.
Reference Standard: Specified requirements defined by the AABB. Reference standards define how or within what parameters an activity shall be performed and are more detailed than quality system requirements.
Registry: An organization that maintains a database of cellular therapy donors or products and coordinates the acquisition of cellular therapy products for transplantation.
Regulation: Rules promulgated by federal, national, state, or local authorities to implement laws enacted by legislative bodies.
Regulatory Enforcement Action: Measures taken by a Competent Authority that include, but are not limited to, progressive measures (eg, suspension or termination of operations, information notices requiring specific documentation or data, fines incurred) or action
based on critical triggers (eg, pattern of recurrent, unresolved issues, deficiencies in risk management systems).
Release: Removal of a product from quarantine or in-process status for the purpose of distribution.
Rework: May include reprocessing, retesting (other than infectious disease testing), or other steps in the manufacturing process that are out of the normal processing sequence or that are not specifically provided for in the process.
Risk: The threat of quantifiable damage or any other negative occurrence that is caused by external or internal vulnerabilities and that may be avoided through preemptive action.
Root Cause(s): The underlying cause(s) of an event or nonconformance that, if eliminated, would prevent recurrence.
Service (noun): An intangible output of a process.
Service (verb): An action that leads to the creation of a product or a result that can affect donors, patients, and/or recipients.
Shall: A term used to indicate a requirement.
Shipping: The physical act of transferring a cellular therapy product within or between facilities. During shipping, the product leaves the control of trained personnel at the originating or receiving facility.
Shipping Facility: A facility responsible for delivering a product in its custody to another location.
Source Material: Cells, tissue, or organs procured from a donor that have not been manipulated or processed.
Specified Requirements: Any requirements in these CT Standards, including, but not limited to, FDA requirements; requirements of a facility’s internal policies, processes, and procedures; manufacturers’ instructions; customer agreements; practice standards; and requirements of accrediting organizations such as the AABB.
Stability: The ability of a product to maintain quality characteristics and resist change or deterioration.
Stability Program: An ongoing sampling program intended to assess the capacity of a cellular therapy product to remain within specifications throughout the retest period or expiration date, as appropriate. Parameters assessed in a stability program may include all or any of the following: identity, viability, potency, sterility, and container integrity.
Stakeholder: An individual, group, or organization that has an interest or concern in activities performed by a facility accredited by AABB, or as defined through an agreement of two or more parties.
Standard: A set of specified requirements upon which an organization may base its criteria for the products, components, and/or services provided.
Statistical Techniques: Established mathematical methods used to collect, analyze, and present data.
Sterility: An aseptic condition, meaning an absence of living microorganisms.
Storage: The state of being kept in a place while not being used or transferred, shipped, or transported.
Storage Device: A piece of equipment used to keep a product in the physical state of storage.
Subject Matter Expert: A person who is qualified, competent, and experienced in a particular task or functional area.
Summary of Records: A condensed version of the required testing and screening records that contains the identity of the testing laboratory, the listing and interpretation of all required infectious disease tests, a listing of the documents reviewed as part of the relevant medical
records, and the name of the person or establishment determining
the suitability of the human tissue for transplantation.
Supplier: An entity that provides a material, product, or service.
Supplier Qualification: Evaluation of a potential supplier to assess its ability to consistently deliver products or services that meet specified requirements.
Surrogate Mother: The female who carries the fertilized ovum of another woman.
System: A subgroup of related activities performed by a particular organization. Activities dealing with maintaining product and service quality are organized into a quality system.
Tissue: Any aggregation of cells and/or associated intercellular matter that usually forms a functional unit and, in the context of cellular therapy, is intended for transplantation or implantation.
Total Nucleated Cell (TNC) Count: The total number of nucleated cells in a volume of a cellular therapy product. Nucleated cells include white blood cell (WBC) populations such as neutrophils, monocytes, lymphocytes, eosinophils, and basophils, and nucleated red blood
cells (NRBCs). The TNC count is calculated by the following formula:
TNC = (WBCs + NRBCs) × volume. The contribution of NRBCs, if any, should be separately noted.
Traceability: The ability to follow the history of a product or service from source to final distribution or disposition using records.
Transfer: The act of relocating a final cellular therapy product or its intermediate in-process precursors.
Transport: The physical act of transferring a cellular therapy product within or between facilities. During transport, the product does not leave the control of trained personnel at the originating or receiving facility.
Unanticipated Event: Unplanned occurrences that can cause serious injury or harm, or death, to an individual, resulting from a deviation(s).
Urgent Medical Need: Procurement and use of a cellular therapy product from an ineligible donor or a donor whose eligibility is incomplete when no comparable product is available and the recipient is likely to suffer serious morbidity or death without receiving the product.
Validation: Establishing evidence that a process, executed by users in their environment, will consistently meet predetermined specifications.
Verification: Confirmation by examination and provision of objective evidence that specified requirements have been met.
Viability: Demonstrated capability of living; indicating (either in-vivo or in-vitro) ability to perform physiologic functions.
Workflow: The planned physical movement of people, materials, or data associated with a process, or the planned temporal sequence of activities associated with a process.