Monday, May 22, 2017
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G.1. GLOSSARY

ALLOGENEIC USE: cells or tissues removed from one person and applied to another.

AUTOLOGOUS USE: cells or tissues removed from and applied to the same person.

BANK OF TISSUES AND CELLS: unit which meets the requirements of national laws and regulations to carry out activities of production, testing, processing, storage and distributing of tissues and/or cells, including import and export, and that is approved for that purpose by the Federal Public Service Public Health.

BIOBURDEN: The level and type (e.g. objectionable or not) of micro-organisms that can be present in raw materials, or advanced therapy medicinal products. Bioburden should not be considered contamination unless the levels have been exceeded or defined objectionable organisms have been detected.

CALIBRATION: The set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material measure, and the corresponding known values of a reference standard.

CELLS: individual human cells or a collection of human cells when not bound by any form of connective tissue.

CLEAN AREA: An area with defined environmental control of particulate and microbial contamination constructed and used in such a way as to reduce the introduction, generation and retention of contaminants within the area. (Note: The different degrees of environmental control are defined in the Supplementary Guidelines for the Manufacture of sterile medicinal products)

CONTAMINATION: The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material or advanced therapy medicinal product during processing, sampling, packaging or repackaging, storage or transport.

CONTROLLED AREA: An area constructed and operated in such a manner that some attempt is made to control the introduction of potential contamination (an air supply approximating to grade D may be appropriate), and the consequences of accidental release of living organisms. The level of control exercised should reflect the nature of the organism employed in the process. At a minimum, the area should be maintained at a pressure negative to the immediate external environment and allow for the efficient removal of small quantities of airborne contaminants.

CRITICAL: potentially having an effect on the quality and/or safety of or having contact with the cells and tissues.

CROSS CONTAMINATION: Contamination of a material or of a product with another material or product.

DEVIATION: Departure from an approved instruction or established standard.

DISTRIBUTION: transportation and delivery of tissues or cells for human applications.

DIRECTED DONATION:  The donation to a specific recipient.

DONOR: every human source, whether living or deceased, of human cells or tissues.

DONATION: donating human tissues or cells intended for human applications.

EXPIRY DATE (OR EXPIRATION DATE): The date placed on the container/labels of an advanced therapy medicinal product designating the time during which this product is expected to remain within established shelf life specifications if stored under defined conditions, and after which it should not be used.

FINISHED PRODUCT: The product which has undergone all stages of production, including packaging in its final container.

HUMAN APPLICATION: the use of tissues or cells on or in a human recipient and extracorporal applications.

INFECTED: Contaminated with extraneous biological agents and therefore capable of spreading infection.

INFORMED CONSENT: Written permission for donation of tissues and cells and for the ulterior use of them.  The donor, one of his relatives or his legal representative must have understood the nature of the donation and the proposed use and accept any implied risks before giving legal consent.

IN-PROCESS CONTROL: Checks performed during production in order to monitor and if necessary to adjust the process to ensure that the product conforms its specification. The control of the environment or equipment may also be regarded as a part of in-process control.

ORGAN CULTURE: a method for medium-term conservation of tissues in medium of cellular culture (particularly applicable to corneas) 

ORGANISATIONS RESPONSIBLE FOR HUMAN APPLICATION (ORHA): a health care establishment or a unit of a hospital or another body which carries out human application of human tissues and cells.

PACKAGING MATERIAL: Any material employed in the packaging of the grafts excluding any outer packaging used for transportation or shipment. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product.

PARTNER DONATION: The donation of reproductive cells between a man and a woman who declare that they have an intimate physical relationship.

PRESERVATION: The use of chemical agents, alterations in environmental conditions or other means during processing to prevent or retard biological or physical deterioration of cells or tissues.

PROCESSING: all operations involved in the preparation, manipulation, preservation and packaging of tissues or cells intended for human applications.

PROCUREMENT ORGANISATION: a health care establishment or a unit of a hospital or another body that undertakes the procurement of human tissues and cells and that may not be accredited, designated, authorised or licensed as a tissue Establishment.

QUALIFICATION: Action of proving that any equipment works correctly and actually leads to the expected results. The word validation is sometimes widened to incorporate the concept of qualification.

QUALITY ASSURANCE: The sum total of the organised arrangements made with the object of ensuring that the product is of the quality required for its intended use and that quality systems are maintained.

QUALITY CONTROL: Checking or testing that specifications are met.

QUALITY MANAGEMENT: the coordinated activities to direct and control an organisation with regard to quality.

QUALITY SYSTEM: the organisational structure, defined responsibilities, procedures, processes, and resources for implementing quality management and includes all activities which contribute to quality, directly or indirectly.

QUARANTINE: the status of retrieved tissue or cells, or tissue isolated physically or by other effective means, whilst awaiting a decision on their acceptance or rejection.

RECIPIENT: the human person on or in which tissues or cells are used.

RECONCILIATION: A comparison, making due allowance for normal variation, between the amount of product or materials theoretically and actually produced or used.

RELEASE: the provision of tissues or cells by a tissue bank for transplantation/ implantation to a recipient

RETURN: Sending back to the tissue establishment of a product which may or may not present a quality defect.

SERIOUS ADVERSE EVENT: any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which might result in, or prolong, hospitalisation or morbidity.

SERIOUS ADVERSE REACTION: an unintended response, including a communicable disease, in the donor or in the recipient associated with the procurement or human application of tissues and cells that is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity.

TISSUE ESTABLISHMENT DOSSIER: document which contains general and specific information concerning the activities and procedures of the organisation concerned.

SPECIFICATION: A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described.  It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use.  ‘Conformance to specification’ means that the material, when tested according to the listed analytical procedures, will meet the listed acceptance criteria.  

STANDARD OPERATING PROCEDURE (SOP): written instruction describing the steps in a specific process, including the materials and methods to be used and the expected end product.

STERILITY: Sterility is the absence of living organisms. The conditions of the sterility test are given in the European Pharmacopoeia.

STORAGE: maintaining the product under appropriate controlled conditions until distribution.

TISSUE: all constituent parts of the human body formed by cells.

TISSUE ESTABLISHMENT: a tissue bank or a unit of a hospital or another body where activities of processing, preservation, storage or distribution of human tissues and cells are undertaken. It may also be responsible for procurement or testing of tissues and cells.

TRACEABILITY: the ability to locate and identify the tissue/cell during any step from procurement, through processing, testing and storage, to distribution to the recipient or disposal, which also implies the ability to identify the donor and the tissue establishment or the manufacturing facility receiving, processing or storage the tissue/cells, and the ability to identify the recipient(s) at the medical facility/facilities applying the tissue/cells to the recipient(s); traceability also covers the ability to locate and identify all relevant data relating to products and materials coming into contact with those tissues/cells.

TRANSFORMATION: any activity related to the preparation, handling, storage and packaging of tissues or cells for human applications.

VALIDATION (OR ‘QUALIFICATION’ IN THE CASE OF EQUIPMENT OR ENVIRONMENTS): means establishing documented evidence that provides a high degree of assurance that a specific process, piece of equipment or environment will consistently produce a product meeting its predetermined specifications and quality attributes; a process is validated to evaluate the performance of a system with regard to its effectiveness based on intended use.

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