WordNet

pass, fare, or elapse; of a certain state of affairs or action; "How is it going?"; "The day went well until I got your call"
a time for working (after which you will be relieved by someone else); "its my go"; "a spell of work" (同)spell, tour, turn
be abolished or discarded; "These ugly billboards have to go!"; "These luxuries all had to go under the Khmer Rouge"
a board game for two players who place counters on a grid; the object is to surround and so capture the opponents counters (同)go game
move away from a place into another direction; "Go away before I start to cry"; "The train departs at noon" (同)go away, depart
lead, extend, or afford access; "This door goes to the basement"; "The road runs South" (同)lead
follow a procedure or take a course; "We should go farther in this matter"; "She went through a lot of trouble"; "go about the world in a certain manner"; "Messages must go through diplomatic channels" (同)proceed, move
be awarded; be allotted; "The first prize goes to Mary"; "Her money went on clothes"
be contained in; "How many times does 18 go into 54?"
be or continue to be in a certain condition; "The children went hungry that day"
be ranked or compare; "This violinist is as good as Juilliard-trained violinists go"
be sounded, played, or expressed; "How does this song go again?"
be spent; "All my money went for food and rent"
functioning correctly and ready for action; "all systems are go"
thorough; "had a good workout"; "gave the house a good cleaning"
moral excellence or admirableness; "there is much good to be found in people" (同)goodness
that which is pleasing or valuable or useful; "weigh the good against the bad"; "among the highest goods of all are happiness and self-realization" (同)goodness
benefit; "for your own good"; "whats the good of worrying?"
not forged; "a good dollar bill" (同)honest
of moral excellence; "a genuinely good person"; "a just cause"; "an upright and respectable man" (同)just, upright
most suitable or right for a particular purpose; "a good time to plant tomatoes"; "the right time to act"; "the time is ripe for great sociological changes" (同)right, ripe
tending to promote physical well-being; beneficial to health; "beneficial effects of a balanced diet"; "a good nights sleep"; "the salutary influence of pure air" (同)salutary
appealing to the mind; "good music"; "a serious book" (同)serious
in excellent physical condition; "good teeth"; "I still have one good leg"; "a sound mind in a sound body" (同)sound
not left to spoil; "the meat is still good" (同)undecomposed, unspoiled, unspoilt
resulting favorably; "its a good thing that I wasnt there"; "it is good that you stayed"; "it is well that no one saw you"; "alls well that ends well" (同)well
agreeable or pleasing; "we all had a good time"; "good manners"
capable of pleasing; "good looks"
generally admired; "good taste"
having desirable or positive qualities especially those suitable for a thing specified; "good news from the hospital"; "a good report card"; "when she was good she was very very good"; "a good knife is one good for cutting"; "this stump will make a good picnic table"; "a good check"; "a good joke"; "a good exterior paint"; "a good secretary"; "a good dress for the office"
morally admirable
carry out or practice; as of jobs and professions; "practice law" (同)practise, exercise, do
a customary way of operation or behavior; "it is their practice to give annual raises"; "they changed their dietary pattern" (同)pattern
translating an idea into action; "a hard theory to put into practice"; "differences between theory and praxis of communism" (同)praxis
the exercise of a profession; "the practice of the law"; "I took over his practice when he retired"
knowledge of how something is usually done; "it is not the local practice to wear shorts to dinner"
avail oneself to; "apply a principle"; "practice a religion"; "use care when going down the stairs"; "use your common sense"; "practice non-violent resistance" (同)apply, use
skillful after much practice (同)practised

PrepTutorEJDIC

《方向・場所を表す副詞[句]を伴って》『行く』,動く;(目的地に関係なく)進む,動く / (ある事をしに)『行く』: / 《副詞[句]を伴って》『立ち去る』,出かける,出発する / 〈機械などが〉(順調に)動く / 《副詞[句]を伴って》〈事が〉『運ぶ』,進展する / (ある状態に)『なる』,変わる / 《『go』+『名』(『形,過分』)〈補〉》(ある状態の)『ままである』 / (…から…に)向かっている,延びている《+『from』+『名』+『to』+『名』》(進行形にできない) / 〈賞品・財産などが〉(…の)ものとなる,(…の手に)渡る《+『to』+『名』》 / 〈金などが〉(…に)使用される,充当される》+『for』(『on,to』)+『名』》 / 有郊である,役立つ / 《副詞[句]を伴って》〈時間が〉過ぎる / 売られる,売れる / なくなる,つぶれる,死ぬ / 《must,can,have toと共に》捨てられる,無用にされる / 《副詞[句]を伴って》(あるべき場所に)位置する,納まる / 〈数量などが〉(…に)等しい《+『to』+『名』》;〈数が〉(…に)含まれる《+『into』+『名』》 / 《副詞[句]を伴って》音を出す,鳴る / 始める,行動に移る / 《副詞[句]を伴って》〈事が〉(…と)なっている(進行形にできない) / 《『as』+『名』+『go』の形で》普通…である,一般には…である / 《『go』『and』 do》《話》 / …しに行く / (愚かにも,不運にも)…をする / 《単なる強調で》…する / 《『go』『going』『to』 do》 / 《話している人の意志》(…する,させる)『つもりである』 / 《可能性・見込み》(…し)『そうである』 / 《近い未来》(…し)ようとしている / 《『go』 do『ing』》 / 《否定文・疑問文で》…するようなことをする / 《『go』+『名』》(…を,に) / 〈C〉行くこと,去ること,進行 / 〈U〉《話》活力,精力 / 〈C〉《話》試し,試み / 〈C〉《単数形で》(ゲームなどでの)番,順番
(物事の内容・程度などが)『よい』,りっぱな,上等の,みごとな;十分な / (道徳的に)『善良な』,徳のある,正しい / (子供が)『行儀がよい』,おとなしい / (行動・目的などが)『適している』 / 『親切な』,優しい,好意的な(kind) / 『十分な』,相当な,たっぷりの / 『じょうずな』,熟練した,有能な,鮮やかな / 『楽しい』,愉快な / 真正な,ほんものの;有効の / 腐っていない,新鮮な,口に合う,おいしい / 《話》十分に / (商取引など)信用できる,信頼できる,確実な / 《呼び掛けに添え》りっぱな / (健康・気分が)よい,元気な / 『よいこと』,善,徳 / 『利益』,幸福 / よく(well)
〈U〉(絶えず繰り返す)『練習』,けいこ / 〈C〉〈U〉(1回の)練習の時間 / 〈U〉(練習で得た)熟練,腕前 / 〈U〉(理論に対して)(…の)『実行』,実施,実際《+『of』+『名』(do『ing』)》 / 〈C〉(…の)『習慣』,しきたり《+『of』+『名』(do『ing』)》 / 〈U〉(医師・弁護士などの)開業 / 〈C〉(医師・弁護士の)業務,仕事 / …‘を'『練習する』,けいこする / (習慣的に)…‘を'『実行する』,実践する / 〈弁護士・医師〉‘を'開業する / (…を)練習する,けいこをする《+『at』(『on, with』)+『名』(do『ing』)》 / (弁護士・医者として)開業する,開業している《+『as』+『名』》
(不動産以外の)財産,(金・証券以外の)動産 / 『商品』,品物 / 《米》反物,織物 / 《英》(鉄道で運ばれる)貨物

Wikipedia preview

出典(authority):フリー百科事典『ウィキペディア（Wikipedia）』「2014/03/31 16:40:52」(JST)

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Good manufacturing practices (GMP) are the practices required in order to conform to guidelines laid down by agencies which control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines are laid down with the intention of providing minimum requirements that a pharmaceutical or a food product manufacturer must meet while manufacturing drugs or food products ,which then assures that the products manufactured/produced are of high quality and do not pose any risk to the consumer or public. Good manufacturing practice guidelines provides guidance for manufacturing, testing, and quality assurance in order to ensure that drug product is safe for human consumption. Many countries have legislated that pharmaceutical and medical device manufacturer must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation. Basic concepts of all of these guidelines remain more or less similar to the ultimate goals of safeguarding the health of patient as well as producing good quality medicine, medical devices or active pharmaceutical products. In the U.S.A a drug may be deemed adulterated even though it has passed all of the specifications tests and it is found to be manufactured in a facility or condition which violates or do not comply with current good manufacturing guideline. Therefore complying with GMP is a mandatory aspect in pharmaceutical manufacturing.

Although there are a number of them, all guidelines follow a few basic principles:

Hygiene: Pharmaceutical manufacturing facility must maintain a clean and hygienic manufacturing area.
Controlled environmental conditions in order to prevent cross contamination of drug product from other drug or extraneous particulate matter which may render the drug product unsafe for human consumption.
Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)
Operators are trained to carry out and document procedures.
Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented.
Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
The distribution of the drugs minimizes any risk to their quality.
A system is available for recalling any batch of drug from sale or supply.
Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.

GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process.

Guideline versions[edit]

GMPs are enforced in the United States by the U.S. Food and Drug Administration (FDA), under Section 501(B) of the 1938 Food, Drug, and Cosmetic Act (21 USCS § 351). The regulations use the phrase "current good manufacturing practices" (cGMP) to describe these guidelines. Courts may theoretically hold that a drug product is adulterated even if there is no specific regulatory requirement that was violated as long as the process was not performed according to industry standards.^{[citation needed]} Since June 2010, a different set of cGMP requirements have applied to all manufacturers of dietary supplements.^[1]

The World Health Organization (WHO) version of GMP is used by pharmaceutical regulators and the pharmaceutical industry in over one hundred countries worldwide, primarily in the developing world. The European Union's GMP (EU-GMP) enforces similar requirements to WHO GMP, as does the FDA's version in the US. Similar GMPs are used in other countries, with Australia, Canada, Japan, Singapore, Philippines and others having highly developed/sophisticated GMP requirements. In the United Kingdom, the Medicines Act (1968) covers most aspects of GMP in what is commonly referred to as "The Orange Guide", which is named so because of the color of its cover; it is officially known as Rules and Guidance for Pharmaceutical Manufacturers and Distributors.^[2]

Since the 1999 publication of GMPs for Active Pharmaceutical Ingredients, by the International Conference on Harmonization (ICH), GMPs now apply in those countries and trade groupings that are signatories to ICH (the EU, Japan and the U.S.), and applies in other countries (e.g., Australia, Canada, Singapore) which adopt ICH guidelines for the manufacture and testing of active raw materials.

Enforcement[edit]

Within the European Union, GMP inspections are performed by National Regulatory Agencies (e.g., GMP inspections are performed in the United Kingdom by the Medicines and Healthcare products Regulatory Agency (MHRA)); in the Republic of Korea (South Korea) by the Korea Food & Drug Administration (KFDA); in Australia by the Therapeutical Goods Administration (TGA); in Bangladesh by the Drug Administration (DGDA); in South Africa by the Medicines Control Council (MCC); in Brazil by the Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency Brazil) (ANVISA); in Iran, in India gmp inspections are carried out by state FDA and these FDA report to Central Drugs Standard Control Organization ^[3] and Pakistan by the Ministry of Health;,^[4] Nigeria has NAFDAC and by similar national organisations worldwide. Each of the inspectorates carry out routine GMP inspections to ensure that drug products are produced safely and correctly; additionally, many countries perform pre-approval inspections (PAI) for GMP compliance prior to the approval of a new drug for marketing.

Regulatory agencies (including the FDA in the U.S. and regulatory agencies in many European nations) are authorized to conduct unannounced inspections, though some are scheduled. FDA routine domestic inspections are usually unannounced, but must be conducted according to 704(A) of the FD&C Act (21 USCS § 374), which requires that they are performed at a "reasonable time". Courts have held that any time the firm is open for business is a reasonable time for an inspection.

Other good practices[edit]

Other good-practice systems, along the same lines as GMP, exist:

Good laboratory practice (GLP), for laboratories conducting non-clinical studies (toxicology and pharmacology studies in animals);
Good clinical practice (GCP), for hospitals and clinicians conducting clinical studies on new drugs in humans;
Good regulatory practice (GRP), for the management of regulatory commitments, procedures and documentation.
Good Distribution Practice (GDP) deals with the guidelines for the proper distribution of medicinal products for human use
Good Transportation Practice (GTP) deals with the guidelines for the proper domestic and international transportation of medicinal products for human use

Collectively, these and other good-practice requirements are referred to as "GxP" requirements, all of which follow similar philosophies. (Other examples include good agriculture practices, good guidance practices, and good tissue practices.) In the U.S., medical device manufacturers must follow what are called "quality system regulations" which are deliberately harmonized with ISO requirements, not cGMPs.

References[edit]

^ "FDA Issues Dietary Supplements Final Rule" (Press release). U.S. Food and Drug Administration. 2007-06-22. Retrieved 2010-06-04.
^ Pharmaceutical Press. "Rules and Guidance for Pharmaceutical Manufacturers and Distributors - Edition: 2007" Retrieved 2010-03-01.
^ "Central Drugs Standard Control Organization Directorate General of Health Services". Cdsco.nic.in. 2011-07-23. Retrieved 2011-08-15.
^ "Ministry of Health & Family Welfare-Government of India". Mohfw.nic.in. Retrieved 2011-08-15.

21 CFR Parts 210/211 Drug GMPs

Sources[edit]

Pharma GMP Guidelines
GMP Audit Checklist

External links[edit]

FDA: Good Manufacturing Practices
Health Canada: Good Manufacturing Practices
Pharmaceutical Inspection Cooperation Scheme: GMP Guides
MHRA Good Manufacturing Guide
Therapeutic Goods Association: Good Manufacturing Practices
WHO: GMP Guidelines
EU: GMP Guidelines

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リンク元	「GMP」「優良製造規範」「優良医薬品製造基準」「医薬品及び医薬部外品の製造管理及び品質管理規則」
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