Current Good Tissue Practices
Encyclopedia
Current Good Tissue Practice (cGTP), also known as Good Tissue Practice (GTP), is a term that is one of the "GxP" requirements derived from cGMP. The rule was written and is enforced by the U.S. Food and Drug Administration (FDA), specifically the Center for Biologics Evaluation and Research
. The authority for the regulation comes from the Public Health Service Act
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
, though the rule itself specifies that the GTPs are 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, blood
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 and tissue used in reproductive medicine (assisted reproductive technology
): sperm
, oocytes, and embryos.
These rules only cover tissue which has not been significantly modified. Any major changes will make the product into either a drug
or a medical device
, 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.
Center for Biologics Evaluation and Research
The Center for Biologics Evaluation and Research is one of six main centers for the U.S. Food and Drug Administration , which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Dr. Karen Midthun, M.D...
. The authority for the regulation comes from the Public Health Service Act
Public Health Service Act
The Public Health Service Act is a United States federal law enacted in 1944. The full act is captured under Title 42 of the United States Code "The Public Health and Welfare", Chapter 6A "Public Health Service"....
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
Code of Federal Regulations
The Code of Federal Regulations is the codification of the general and permanent rules and regulations published in the Federal Register by the executive departments and agencies of the Federal Government of the United States.The CFR is published by the Office of the Federal Register, an agency...
, though the rule itself specifies that the GTPs are 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, blood
Blood
Blood is a specialized bodily fluid in animals that delivers necessary substances such as nutrients and oxygen to the cells and transports metabolic waste products away from those same cells....
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 and tissue used in reproductive medicine (assisted reproductive technology
Assisted reproductive technology
Assisted reproductive technology is a general term referring to methods used to achieve pregnancy by artificial or partially artificial means. It is reproductive technology used primarily in infertility treatments. Some forms of ART are also used in fertile couples for genetic reasons...
): sperm
Sperm
The term sperm is derived from the Greek word sperma and refers to the male reproductive cells. In the types of sexual reproduction known as anisogamy and oogamy, there is a marked difference in the size of the gametes with the smaller one being termed the "male" or sperm cell...
, oocytes, and embryos.
These rules only cover tissue which has not been significantly modified. Any major changes will make the product into either a drug
Drug
A drug, broadly speaking, is any substance that, when absorbed into the body of a living organism, alters normal bodily function. There is no single, precise definition, as there are different meanings in drug control law, government regulations, medicine, and colloquial usage.In pharmacology, a...
or a medical device
Medical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...
, 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.