Good tissue practice (GTP) is one of the "

GxP GXP may refer to: * GxP a generalization of quality guidelines * Great Plains Energy, an American utility holding company * ''Tenchi Muyo! GXP is a Japanese anime television series animated by AIC and broadcast on NTV from April 3 to Se ...

" requirements derived from

good manufacturing practice Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutic ...

. The rule was written and is enforced by the U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

(FDA), specifically the

Center for Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Vinay Pras ...

. The authority for the regulation comes from the

Public Health Service Act The Public Health Service Act is a Law of the United States, United States federal law enacted in 1944. The full act is codified in Title 42 of the United States Code (The Public Health and Welfare), Chapter 6A (United States Public Health Servi ...

and all of the requirements relate to transmission of communicable disease, including bacterial or fungal contamination during processing. It is generally used to mean the requirements of section 1271 of chapter 21 of the US

Code of Federal Regulations In the law of the United States, the ''Code of Federal Regulations'' (''CFR'') is the codification of the general and permanent regulatory law, regulations promulgated by the executive departments and agencies of the federal government of the ...

, though the rule itself specifies that the GTP is only subpart D of that section. The rules cover a broad variety of articles referred to as "HCT/Ps" for human cellular, tissue, and tissue-based products and the regulations cover more or less any cellular entity taken from a human and transplanted into another human. There are several exceptions in the rules for

organ transplants Organ transplantation is a medical procedure in which an organ is removed from one body and placed in the body of a recipient, to replace a damaged or missing organ. The donor and recipient may be at the same location, or organs may be trans ...

blood Blood is a body fluid in the circulatory system of humans and other vertebrates that delivers necessary substances such as nutrients and oxygen to the cells, and transports metabolic waste products away from those same cells. Blood is com ...

for transfusion, and other articles which already have established requirements. The rules are an expansion and revision of the section 1270 of the same chapter and now cover a larger group of products. The most controversial products covered in these rules include

stem cells In multicellular organisms, stem cells are undifferentiated or partially differentiated cells that can change into various types of cells and proliferate indefinitely to produce more of the same stem cell. They are the earliest type of cell ...

and tissue used in reproductive medicine (

assisted reproductive technology Assisted reproductive technology (ART) includes medical procedures used primarily to address infertility. This subject involves procedures such as in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), and cryopreservation of ga ...

sperm Sperm (: sperm or sperms) is the male reproductive Cell (biology), cell, or gamete, in anisogamous forms of sexual reproduction (forms in which there is a larger, female reproductive cell and a smaller, male one). Animals produce motile sperm ...

oocytes An oocyte (, oöcyte, or ovocyte) is a female gametocyte or germ cell involved in reproduction. In other words, it is an immature ovum, or egg cell. An oocyte is produced in a female fetus in the ovary during female gametogenesis. The female ger ...

, and

embryos An embryo ( ) is the initial stage of development for a multicellular organism. In organisms that reproduce sexually, embryonic development is the part of the life cycle that begins just after fertilization of the female egg cell by the male spe ...

. These rules only cover tissue which has not been significantly modified. Any major changes will make the product into either a

drug A drug is any chemical substance other than a nutrient or an essential dietary ingredient, which, when administered to a living organism, produces a biological effect. Consumption of drugs can be via insufflation (medicine), inhalation, drug i ...

or a

medical device A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...

, though some of the rules in this section still apply to human-sourced drugs and medical devices. The rules only affect products collected after May 25, 2005.

FDA Draft Guidance January 2009

In January 2009, FDA issued a new cGTP draft guidance for industry entitled "Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)".

References

{{reflist

FDA Draft Guidance January 2009

References

See also