Good Tissue Practices definition

Good Tissue Practices or “GTP” means the part of quality assurance which ensures requirements governing the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps, including all steps in recovery, donor screening, donor testing, processing, storage, labeling, packaging, and distribution as defined in U.S. subparts C and D of 21 CFR part 1271 or (as applicable) any equivalent or similar standards in jurisdictions outside the United States, to the extent such standards are not less stringent than U.S. Good Tissue Practice.

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Good Tissue Practices means the current good tissue practices for HCT/Ps required by applicable Law, including those contained in 21 C.F.R. Part 1271 as in effect at the time of manufacture, and the equivalent applicable Laws by a comparable foreign Governmental Body in any other country or jurisdiction in which Products are manufactured, used or sold.

Good Tissue Practices means the FDA’s standards for manufacturing and processing human cells, tissues, and cellular and tissue-based products, including those standards contained in 21 C.F.R. Part 1271, and all comparable Legal Requirements, including standards of the EMA and any other Specified Governmental Body.

Examples of Good Tissue Practices in a sentence

The Work in Process shall have been manufactured in accordance with then current Good Tissue Practices, as set forth by the FDA, and all applicable laws, rules, regulations, ordinances, standards and guidelines, including, without limitation, the United States Federal Food, Drug and Cosmetic Act, 21 U.S.C. §301 et seq., and the United States National Organ Transplant Act, Title 21 of the Code of Federal Regulations Part 1271, Human Cells, Tissues, and Cellular and Tissue Based Products.
To the extent appropriate for Inventory, all Inventory has been processed, manufactured, packaged, labeled, stored, handled, and distributed by Osiris in compliance with Osiris quality control standards and all applicable laws including Good Tissue Practices and the United States National Organ Transplant Act.
Without limiting the foregoing, if applicable, and to the extent expressly provided in an Exhibit, such party will perform its obligations under this Agreement and any Exhibit in accordance with the Quality System Regulation (“QSR”), current Good Manufacturing Practices (“cGMP”), current Good Tissue Practices (“cGTP”), Good Clinical Practices (“GCP”) ,Good Laboratory Practices (“GLP”), and/or American Association of Tissue Banks Standards (“AATB”), as applicable.
Distributor shall ensure that it has established and maintained current Good Tissue Practices (a/k/a "cGTP") in compliance with all applicable FDA requirements, including 21 C.F.R. Part 1271, as applicable.
Tutogen agrees to comply with and maintain compliance with all applicable governmental rules, regulations, statutes and other laws of any kind necessary to manufacture, import into and distribute the Biologic Implants within the Territory, including, without limitation, FDA laws, regulation and guidance, including the then current Good Tissue Practices Regulations), the National Organ Transplant Act, the AATB Standards and other generally accepted industry standards.
To the extent required by applicable Law, Distributor shall establish and maintain a quality system intended to prevent the introduction, transmission, or spread of communicable diseases through the storage, shipment, handling, and distribution of Human Cell and Tissue Products (HCT/Ps) in accordance with the requirements of 21 C.F.R. Part 1271 and generally accepted industry standards related to Good Tissue Practices as promulgated by the FDA and the American Association of Tissue Banks.
All samples provided ACTIVE/99344198.6 by human donors have been detailed in the compliance informed consent as being the property of the donor and the donor may choose to withdraw the use of their sample for the Sellers’ research at any time in accordance with the Good Tissue Practices.
All manufacture of Company Products, including all clinical supplies used in clinical trials, by or on behalf of the Company has been conducted in compliance with the applicable specifications and requirements of Good Manufacturing Practices, Good Tissue Practices, and all other applicable Laws.
The Company and its Subsidiaries have conducted, and currently are conducting, all research, development, production and clinical and/or preclinical studies in accordance, in all material respects, with Current Good Tissue Practices, Good Clinical Practices and Good Laboratory Practices as issued by the FDA, and in accordance, in all material respects, with the parameters and guidelines of any applicable research or development grant program, whether awarded by a governmental or private entity.

More Definitions of Good Tissue Practices

Good Tissue Practices equivalently Current Good Tissue Practice (CGTP), means requirements under Title 21 Code of Federal Regulations, Part 1271 (21 CFR Part 1271), Subparts D and E.

Good Tissue Practices mean the then current standards for the manufacture, processing, packaging, transportation, handling and holding of human cells, tissues, and cellular and tissue-based products as set forth in the FDCA and applicable regulations promulgated thereunder, as amended from time to time, including applicable requirements contained in 21 C.F.R. Part 1271, and such applicable standards of good tissue practices as are required by Governmental Entities in any other countries in which the Company Products are sold or distributed or intended to be sold or distributed.