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.
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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.
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Examples of Good Tissue Practices in a sentence

  • GLP data is required in the development of any human therapeutic and we plan to design our technology platform to support compliance with GLPAs. As we move into clinical and commercial settings, full compliance with the FDA’s cGTP (current Good Tissue Practices) and cGMP (current Good Manufacturing Practices) guidelines will be required for suitable design and documentation for clinical use of our products.

  • 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.

  • 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.

  • 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.

  • 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.


More Definitions of Good Tissue Practices

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.
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Related to Good Tissue Practices

  • ISO-NE Practices means the ISO-NE practices and procedures for delivery and transmission of energy in effect from time to time and shall include, without limitation, applicable requirements of the NEPOOL Agreement, and any applicable successor practices and procedures.

  • Good Industry Practices means the practices that would be adopted by, and the exercise of that degree of care, skill, diligence, prudence and foresight that reasonably would be expected from, a competent contractor in the international oil and gas industry experienced in performing work similar in nature, size, scope and complexity to the Work and under conditions comparable to those applicable to the Work, where such work is subject to, and such contractor is seeking to comply with, the standards and codes specified in the Contract or (to the extent that they are not so specified) such national or international standards and codes as are most applicable in the circumstances, and the applicable Law.

  • Unfair trade practices means supply of services different from what is ordered on, or change in the Scope of Work;

  • Good Practice means such practice in the processing of personal data as appears to the Commissioner to be desirable having regard to the interests of data subjects and others, and includes (but is not limited to) compliance with the requirements of this Act;

  • Best Practices means a term that is often used inter-changeably with “evidence- based practice” and is best defined as an “umbrella” term for three levels of practice, measured in relation to Recovery-consistent mental health practices where the Recovery process is supported with scientific intervention that best meets the needs of the Client at this time.

  • Group practice means a group of two or more health care providers legally organized as a partnership, professional corporation, or similar association:

  • coercive practices means harming or threatening to harm, directly or indirectly, persons, or their property to influence their participation in a procurement process, or affect the execution of a contract;

  • Active practice means post-licensure practice at the level of licensure for which an applicant is seeking licensure in Virginia and shall include at least 360 hours of practice in a 12-month period.

  • collusive practices means a scheme or arrangement between two or more Bidders, with or without the knowledge of the Procuring Entity, designed to establish bid prices at artificial, non-competitive levels.

  • Codes of Practice shall have the meaning given to the term in Clause 1.2 of Schedule 3;

  • Good Industry Practice means standards, practices, methods and procedures conforming to the Law and the degree of skill and care, diligence, prudence and foresight which would reasonably and ordinarily be expected from a skilled and experienced person or body engaged in a similar type of undertaking under the same or similar circumstances.

  • Good Clinical Practices means the FDA’s standards for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials contained in 21 C.F.R. Part 50, 54, 56, 312, 314, 320, 812, and 814 and (ii) “Good Laboratory Practices” means the FDA’s standards for conducting non-clinical laboratory studies contained in 21 C.F.R. Part 58.

  • Privilege to practice means: an individual's authority to deliver emergency medical services in remote states as authorized under this compact.

  • Unfair practice means (i) establishing contact with any person connected with or employed or engaged by the Authority with the objective of canvassing, lobbying or in any manner influencing or attempting to influence the Bidding Process; or (ii) having a Conflict of Interest; and

  • Unfair labor practice means the commission of an act designated an unfair labor practice

  • Good Laboratory Practices or “GLP” means the then-current good laboratory practice standards promulgated or endorsed by the FDA, as defined in U.S. 21 C.F.R. Part 58 (or such other comparable regulatory standards in jurisdictions outside the United States, as they may be updated from time to time).

  • Unfair trade practice means supply of services different from what is ordered on, or change in the Scope of Work.

  • Prohibited Practices means the prohibited practices set forth in paragraph 4 of the Policy on Prohibited Practices;

  • obstructive practices which means harming or threatening to harm, directly or indirectly, persons to influence their participation in a procurement process, or affect the execution of a contract;

  • Standards of Practice means the care, skill, and

  • Employment Practices means any wrongful or unfair dismissal, denial of natural justice, defamation, misleading representation or advertising, unfair contracts, harassment or discrimination (sexual or otherwise) in respect of employment by the Insured.

  • Evidence-based practices means policies, procedures, programs, and practices proven by scientific research to reliably produce reductions in recidivism;

  • Past Practices shall have the meaning set forth in Section 3.5.

  • fradulent practice means a misrepresentation or omission of facts in order to influence a procurement process or the execution of contract;

  • fraudulent practices which means any act or omission, including a misrepresentation, that knowingly or recklessly misleads, or attempts to mislead, a party to obtain a financial or other benefit or to avoid an obligation; and

  • Good Manufacturing Practices or “GMP” shall mean the then current Good Manufacturing Practices as such term is defined from time to time by the FDA or other relevant Governmental Authority having jurisdiction over the development, manufacture or sale of the Product in the Territory pursuant to its regulations, guidelines or otherwise.