The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
Transfusion medicine is the branch of medicine that encompasses all aspects of the transfusion of blood and blood components including aspects related to hemovigilance. It includes issues of blood donation, immunohematology and other laboratory testing for transfusion-transmitted diseases, management and monitoring of clinical transfusion practices, patient blood management, therapeutic apheresis, stem cell collections, cellular therapy, and coagulation. Laboratory management and understanding of state and federal regulations related to blood products are also a large part of the field.
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, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical Guidelines and requirements for pharmaceutical product registration.
The National Medical Products Administration is a national bureau responsible for drug supervision under the State Council of China and is managed by the State Administration for Market Regulation.
In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products in development for human or animal health through non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.
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 Peter Marks, M.D., PhD. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biologics and related products. Not all biologics are regulated by CBER. Monoclonal antibodies and other therapeutic proteins are regulated by the FDA Center for Drug Evaluation and Research (CDER).
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia.
Food safety in China is a widespread concern for the country's agricultural industry. China's principal crops are rice, corn, wheat, soybeans, and cotton in addition to apples and other fruits and vegetables. China's principal livestock products include pork, beef, dairy, and eggs. The Chinese government oversees agricultural production as well as the manufacture of food packaging, containers, chemical additives, drug production, and business regulation. In recent years, the Chinese government attempted to consolidate food safety regulation with the creation of the State Food and Drug Administration of China in 2003; officials have also been under increasing public and international pressure to solve food safety problems. Chinese Vice Premier Li Keqiang said, "Food is essential, and safety should be a top priority. Food safety is closely related to people's lives and health and economic development and social harmony," at a State Council meeting in Beijing.
The Office of Global Regulatory Operations and Policy (GO), also known as the Office of Regulatory Affairs (ORA), is the part of the U.S. Food and Drug Administration (FDA) enforcing the federal laws governing biologics, cosmetics, dietary supplements, drugs, food, medical devices, radiation-emitting electronic devices, tobacco products, and veterinary medicine products which may have potentially harmful side effects for the consumer.
The South African National Accreditation System (SANAS) is the official accreditation body for South Africa. Founded in 1996, SANAS is headquartered in Pretoria, South Africa. SANAS accreditation certificates are a formal recognition by the Government of South Africa that an organisation is competent to perform specific tasks.
A medical laboratory or clinical laboratory is a laboratory where tests are conducted out on clinical specimens to obtain information about the health of a patient to aid in diagnosis, treatment, and prevention of disease. Clinical medical laboratories are an example of applied science, as opposed to research laboratories that focus on basic science, such as found in some academic institutions.
Verification and validation are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party. "Independent verification and validation" can be abbreviated as "IV&V".
Regulatory science is the scientific and technical foundations upon which regulations are based in various industries – particularly those involving health or safety. Regulatory bodies employing such principles in the United States include, for example, the FDA for food and medical products, the EPA for the environment, and the OSHA for work safety.
The Pharmaceuticals and Medical Devices Agency (PhMDA) is an Independent Administrative Institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan. It is similar in function to the Food and Drug Administration in the United States, the Medicines and Healthcare products Regulatory Agency in the United Kingdom, the Spanish Agency of Medicines and Medical Devices in Spain or the Food and Drug Administration in the Philippines.
The Food and Drug Administration (FDA) of the Philippines, formerly the Bureau of Food and Drugs, is a health regulatory agency under the Department of Health created on 1963 by Republic Act No. 3720, amended on 1987 by Executive Order 175 otherwise known as the “Food, Drugs and Devices, and Cosmetics Act”, and subsequently reorganized by Republic Act No. 9711 otherwise known as “The Food and Drug Administration Act of 2009”. The agency is responsible for licensing, monitoring, and regulation of cosmetics, drugs, foods, household hazardous products, medical devices and electromagnetic radiation emitting devices, pesticides, tobacco and related products, and vaccines for safety, efficacy, and quality in the Republic of the Philippines.
A certificate of analysis (COA) is a formal laboratory-prepared document that details the results of one or more laboratory analyses, signed—manually or electronically—by an authorized representative of the entity conducting the analyses. This document gives assurances to the recipient that the analyzed item is what it is designated to be, or has the features advertised by the producer. The design and content of a COA may be based upon a set of requirements identified by the lab, by regulatory-driven requirements, and/or by standards developed by standard developing organizations. The COA is used in a wide variety of industries, including but not limited to the agriculture, chemical, clinical research, food and beverage, and pharmaceutical industries.
The International Coalition of Medicines Regulatory Authorities (ICMRA) is a global conference of government health bureaucrats.
