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Good Manufacturing Practice
GOOD MANUFACTURING PRACTICES (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products . These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public. Good manufacturing practices, along with good agricultural practices , good laboratory practices and good clinical practices , are overseen by regulatory agencies in the United Kingdom, United States, Canada, Europe, China, and other countries
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Active Pharmaceutical Ingredient
An ACTIVE INGREDIENT (AI) is the ingredient in a pharmaceutical drug that is biologically active . The similar terms ACTIVE PHARMACEUTICAL INGREDIENT (API) and BULK ACTIVE are also used in medicine, and the term ACTIVE SUBSTANCE may be used for natural products. Some medication products may contain more than one active ingredient. The traditional word for the API is PHARMACON or PHARMAKON (from Greek : φάρμακον, adapted from pharmacos ) which originally denoted a magical substance or drug. The term ACTIVE CONSTITUENT is often chosen when referring to the active substance of interest in a plant (such as salicylic acid in willow bark or arecoline in areca nuts ), because the word ingredient in many minds connotes a sense of human agency (that is, something that a person combines with other substances), whereas the natural products present in plants were not added by any human agency but rather occurred naturally ("a plant doesn't have ingredients")
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Good Agricultural Practice
GOOD AGRICULTURAL PRACTICE (GAP) are specific methods which, when applied to agriculture , create food for consumers or further processing that is safe and wholesome. While there are numerous competing definitions of what methods constitute good agricultural practice there are several broadly accepted schemes that producers can adhere to
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Good Laboratory Practice
In the experimental (non-clinical) research arena, the phrase GOOD LABORATORY PRACTICE or GLP specifically refers to a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability , reproducibility , quality, and integrity of chemical (including pharmaceuticals) non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests. GLP was first introduced in New Zealand and Denmark in 1972, and later in the US in 1978 in response to the Industrial BioTest Labs scandal. It was followed a few years later by the Organization for Economic Co-operation and Development (OECD) Principles of GLP in 1992; the OECD
OECD
has since helped promulgate GLP to many countries. GLP applies to non-clinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals) to man, animals and the environment
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Good Clinical Practice
GOOD CLINICAL PRACTICE (GCP) is an international quality standard that is provided by ICH , an international body that defines a set of standards, which governments can then transpose into regulations for clinical trials involving human subjects. A similar guideline for clinical trials of medical devices is the international standard ISO 14155 , which is valid in the European Union
European Union
as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines. GCP follows the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) of GCP guidelines. GCP enforces tight guidelines on ethical aspects of a clinical study
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Validation (drug Manufacture)
VALIDATION is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results. The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines
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Good Documentation Practice
GOOD DOCUMENTATION PRACTICE (commonly abbreviated GDP, recommended to abbreviate as GDOCP to distinguish from "good distribution practice " also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDP / GDocP standards are codified by various competent authorities , others are not but are considered cGMP (with emphasis on the "c", or "current"). Some competent authorities release or adopt guidelines , and they may include non-codified GDP / GDocP expectations. While not law, authorities will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make comments or observations if departures are seen. In the past years, the application of GDocP is also expanding to cosmetic industry, excipient and ingredient manufacturers
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Food Allergen Labeling And Consumer Protection Act
THE FOOD ALLERGEN LABELING AND CONSUMER PROTECTION ACT (FALCPA) is a United States law that requires all food labels in the United States to list ingredients that may cause allergic reactions, and was effective as of January 1, 2006. While many ingredients can trigger a food allergy, this legislation only specifies the eight major food allergens. This law was passed largely due to the efforts of organizations such as the Food Allergy "> * ^ A B Thompson, Tricia; Kane, Rhonda R.; Hager, Mary H. (November 2006). " Food Allergen Labeling and Consumer Protection Act of 2004 in Effect". Journal of the American Dietetic Association. 106 (11): 1742–1744. doi :10.1016/j.jada.2006.08.010 . PMID 17081820 . * ^ Public Law. "Food Allergen Labeling and Consumer Protection Act". FARE. Retrieved 3 July 2013. * ^ FDA. " Food Allergen Labeling and Consumer Protection Act of 2004 Questions and Answers". Retrieved 2 July 2013
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Food And Drug Administration
The FOOD AND DRUG ADMINISTRATION (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services , one of the United States federal executive departments . The FDA is responsible for protecting and promoting public health through the control and supervision of food safety , tobacco 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 the FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs. These include regulating lasers, cellular phones, condoms and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction
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21 CFR
TITLE 21 is the portion of the Code of Federal Regulations
Code of Federal Regulations
that governs food and drugs within the United States
United States
for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). It is divided into three chapters: * Chapter I — Food and Drug Administration * Chapter II — Drug Enforcement Administration * Chapter III — Office of National Drug Control Policy CONTENTS * 1 Chapter I * 2 Chapter II * 3 Chapter III * 4 See also * 5 Notes * 6 External links CHAPTER IMost of the Chapter I regulations are based on the Federal Food, Drug, and Cosmetic Act
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Adulterated
An ADULTERANT is a pejorative term for a substance found within other substances such as food , fuels or chemicals even though it is not allowed for legal or other reasons. It will not normally be present in any specification or declared contents of the substance, and may not be legally allowed. The addition of adulterants is called ADULTERATION. The most common reason for adulteration is the use by manufacturers of undeclared materials that are cheaper than the correct and declared ones. The adulterants may be harmful, or reduce the potency of the product, or they may be harmless. The term "contamination " is usually used for the inclusion of unwanted substances due to accident or negligence rather than intent, and also for the introduction of unwanted substances after the product has been made
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Dietary Supplement
A dietary supplement is either intended to provide nutrients in order to increase the quantity of their consumption, or to provide non-nutrient chemicals which are claimed to have a biologically beneficial effect. Supplements as generally understood include vitamins , minerals , fiber , fatty acids , or amino acids , among other substances. U.S. authorities define dietary supplements as foods, while elsewhere they may be classified as drugs or other products. There are more than 50,000 dietary supplements available. More than half of the U.S. adult population (53% – 55%) consume dietary supplements with most common ones being multivitamins. These products are not intended to prevent or treat any disease and in some circumstances are dangerous, according to the U.S. National Institutes of Health
Health

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World Health Organization
World Health Organization Organisation mondiale de la santé (in French) Flag of the World Health Organization ABBREVIATION WHO OMS FORMATION 7 April 1948; 69 years ago (1948-04-07) TYPE Specialized agency of the United Nations LEGAL STATUS Active HEADQUARTERS Geneva , Switzerland HEAD Tedros Adhanom , Director-General PARENT ORGANIZATION United Nations Economic and Social Council (ECOSOC) WEBSITE www.who.intThe WORLD HEALTH ORGANIZATION (WHO) is a specialized agency of the United Nations that is concerned with international public health . It was established on 7 April 1948, headquartered in Geneva , Switzerland. The WHO is a member of the United Nations Development Group . Its predecessor, the Health Organization , was an agency of the League of Nations
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Pharmaceutical Industry
The PHARMACEUTICAL INDUSTRY discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications . Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting , testing, safety, efficacy and marketing of drugs
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European Union
The EUROPEAN UNION (EU) is a political and economic union of 28 member states that are located primarily in Europe . It has an area of 4,475,757 km2 (1,728,099 sq mi), and an estimated population of over 510 million. The EU has developed an internal single market through a standardised system of laws that apply in all member states. EU policies aim to ensure the free movement of people, goods, services, and capital within the internal market, enact legislation in justice and home affairs, and maintain common policies on trade, agriculture , fisheries , and regional development . Within the Schengen Area , passport controls have been abolished. A monetary union was established in 1999 and came into full force in 2002, and is composed of 19 EU member states which use the euro currency
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Australia
Coordinates : 25°S 133°E / 25°S 133°E / -25; 133 Commonwealth of Australia Flag Coat of arms ANTHEM: " Advance Australia Fair " CAPITAL Canberra 35°18′29″S 149°07′28″E / 35.30806°S 149.12444°E / -35.30806; 149.12444 LARGEST CITY Sydney NATIONAL LANGUAGE English RELIGION * 52.1% Christianity * 30.1% No religion * 9.6% Not stated or unclear * 2.6%
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