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.
Sample 1Sample 2
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.
Sample 1Sample 2
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.
Sample 1

Examples of Good Tissue Practices in a sentence

  • The manufacturing area is an FDA registered facility and is designed and operates to meet FDA compliance and environmental quality requirements as defined in the Good Manufacturing Practice (GMP) and Good Tissue Practices (GTP) guidelines.

  • 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.

  • The manufacturing area is an FDA registered facility and is designed and operates to meet FDA compliance and environmental quality requirements as defined in the Good Manufacturing Practices (GMP) and Good Tissue Practices (GTP) guidelines.

  • The project aims:• To develop detailed European Good Tissue Practices for the activities carried out in tissue establishments (TE), contributing to the harmonization of these activities among European TEs.• To develop a training model for TE personnel based on the GTPs.The Good Tissue Practices, as well as the Training Model should contribute to the harmonization of tissue banking activities and specific procedures in Europe, in order to provide tissues for transplant of high quality and safety.

  • 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.

  • 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.

  • The Facility manufactures cellular products which fulfil international regulatory Good Tissue Practices (GTP) and GMP requirements.

  • The manufacture of our patient-specific, expanded multicellular therapies is done under current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) guidelines required by the FDA.

  • Merchants and others who honor your Card may give credit for returns or adjustment, and they will do so by submitting to the Credit Union processor a credit slip, which will be posted to your Account.

  • 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.


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.
Sample 1

Related to Good Tissue Practices

  • Proper practices means those set out in The Practitioners’ Guide

  • 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;

  • Restorative practices means practices that emphasize repairing the harm to the victim and the school community caused by a student's misconduct.

  • 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 24 practice” and is best defined as an “umbrella” term for three levels of practice, measured in relation to 25 recovery-consistent mental health practices where the recovery process is supported with scientific 26 intervention that best meets the needs of the Client at this time. 27 a. EBP means Evidence-Based Practices and refers to the interventions utilized for which 28 there is consistent scientific evidence showing they improved Client outcomes and meets the following 29 criteria: it has been replicated in more than one geographic or practice setting with consistent results; it

  • 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 means all codes of practice, rules of procedure, guidelines, directions, scheme rules and other requirements issued by the Bank System and specified from time to time as being applicable to the EMV PSP Service and your use of those.

  • 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 (or similar standards) for the performance of laboratory activities for pharmaceutical products as are required by applicable Regulatory Authorities or Applicable Law. In the United States, Good Laboratory Practices are established through FDA regulations (including 21 C.F.R. Part 58), FDA guidance, FDA current review and inspection standards and current industry standards.

  • 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;

  • 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 means current good manufacturing practices, as set forth in 21 C.F.R. Parts 210 and 211.