![]() ![]() Examples include, but are not limited to, cell viability, cell identity, cell yield/number/concentration, cell composition, purity, potency and contamination from adventitious agents, bacteria, endotoxin or mycoplasma. Specifications should monitor key aspects of product quality, taking into account both the safety and potency. Transmissible Spongiform Encephalopathies (TSE):Īll progressive neurodegenerative disorders caused by prions in animals and humans that produce spongiform changes in the brain.ĭS and DP specifications are an important tool for establishing and monitoring the quality of the manufacturing process and setting limits for key parameters of a cell therapy product. Materials which are intended to be used in the manufacture of a drug substance and from which the active ingredient is derived either directly or indirectly. Operational techniques and activities that are used to fulfil requirements for quality in compliance with the specification.Īny materials used in manufacturing that are procured from outside sources.Īny cells that have differentiated (i.e., not stem cells or gametes).Ī predefined combination of testing methods and acceptance criteria intended for routine quality control of materials for and from manufacturing including but not limited to raw materials, starting materials, drug substance, drug product and packaging materials. Guidance Document for Cell, Tissue and Organ Establishments - Safety of Human Cells, Tissues and Organs for Transplantation).Īll planned and systematic activities implemented within the quality system and demonstrated as needed to provide adequate confidence that an entity will fulfil requirements for quality. ![]() In respect of cells and non-structural tissue, that the processing does not alter the biological characteristics that are relevant to their claimed utility (for examples, see Section 2 of the This response is complex and can include antibody formation as well as other events such as T cell activation or innate immune response activation that could contribute to adverse responses.Īny component of the drug product that is not the drug substance or an excipient in the drug product. The ability of a product to induce an immune response, which can be influenced by various factors, including patient-/disease-related factors and product-related factors. In respect of a cell, tissue or organ, the cell, tissue or organ performs the same basic function after transplantation. Division 1A, Part C of theįood and Drug Regulations defines activities for which GMP compliance is to be demonstrated prior to the issuance of a drug establishment licence. ![]() The organizational process and the conditions under which laboratory studies are planned, performed, monitored, recorded, archived and reported.Ī defined system of determinants and controls for quality production, applicable to the manufacturing of drugs (see Division 2 of theįood and Drug Regulations). The final dosage form of a drug that is placed in the immediate packaging intended for marketing.Ī defined process intermediate containing the active ingredient, which is subsequently formulated with excipients to produce the drug product.Īny enterprise, utility or body that is involved in any aspect of the processing, manufacturing, storage and/or distribution of a drug. Material from a biological source which is intended to be used in the manufacture of a substance from which the active ingredient is derived either directly (e.g., bone marrow, blood, tissue, etc.) or indirectly (e.g., cell substrates, host/vector production cells, eggs, viral strains etc.). ![]() Also known as an autograft.Īny reagent used in drug manufacturing that is not intended to be present in the final product Transplantation of cells or tissues removed, processed and returned to the same patient. Transplantation of cells or tissues from one individual to another. Microbiological contaminants that may be inadvertently introduced during the manufacturing process of a biologic drug. ![]()
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