good laboratory practice

優良試験所基準、優良実験室規範

関

GLP

WordNet

1. 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"
2. a time for working (after which you will be relieved by someone else); "its my go"; "a spell of work" (同)spell, tour, turn
3. be abolished or discarded; "These ugly billboards have to go!"; "These luxuries all had to go under the Khmer Rouge"
4. 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
5. move away from a place into another direction; "Go away before I start to cry"; "The train departs at noon" (同)go away, depart
6. lead, extend, or afford access; "This door goes to the basement"; "The road runs South" (同)lead
7. 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
8. be awarded; be allotted; "The first prize goes to Mary"; "Her money went on clothes"
9. be contained in; "How many times does 18 go into 54?"
10. be or continue to be in a certain condition; "The children went hungry that day"
11. be ranked or compare; "This violinist is as good as Juilliard-trained violinists go"
12. be sounded, played, or expressed; "How does this song go again?"
13. be spent; "All my money went for food and rent"
14. functioning correctly and ready for action; "all systems are go"
15. thorough; "had a good workout"; "gave the house a good cleaning"
16. moral excellence or admirableness; "there is much good to be found in people" (同)goodness
17. 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
18. benefit; "for your own good"; "whats the good of worrying?"
19. not forged; "a good dollar bill" (同)honest
20. of moral excellence; "a genuinely good person"; "a just cause"; "an upright and respectable man" (同)just, upright
21. 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
22. 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
23. appealing to the mind; "good music"; "a serious book" (同)serious
24. in excellent physical condition; "good teeth"; "I still have one good leg"; "a sound mind in a sound body" (同)sound
25. not left to spoil; "the meat is still good" (同)undecomposed, unspoiled, unspoilt
26. 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
27. agreeable or pleasing; "we all had a good time"; "good manners"
28. capable of pleasing; "good looks"
29. generally admired; "good taste"
30. 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"
31. morally admirable
32. carry out or practice; as of jobs and professions; "practice law" (同)practise, exercise, do
33. a customary way of operation or behavior; "it is their practice to give annual raises"; "they changed their dietary pattern" (同)pattern
34. translating an idea into action; "a hard theory to put into practice"; "differences between theory and praxis of communism" (同)praxis
35. the exercise of a profession; "the practice of the law"; "I took over his practice when he retired"
36. knowledge of how something is usually done; "it is not the local practice to wear shorts to dinner"
37. 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

PrepTutorEJDIC

1. 《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
2. (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)
3. 〈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』》
4. (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
5. 『実験室』,研究室(所),試験室(所);(薬品などの)製造所

Wikipedia preview

出典(authority):フリー百科事典『ウィキペディア（Wikipedia）』「2015/10/29 01:43:08」(JST)

wiki en

[Wiki en表示]

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 try 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 Organisation for Economic Co-operation and Development (OECD) Principles of GLP in 1992; the 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. An internationally recognized definition of GLP can be found on the website for the Medicines and Healthcare products Regulatory Agency-UK which defines GLP as:

Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals (only preclinical studies), agrochemicals, cosmetics, food additives, feed additives and contaminants, novel foods, biocides, detergents etc.... GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.

GLP, a data quality system, should not be confused with standards for laboratory safety - appropriate gloves, glasses & clothing to handle lab materials safely.

History

GLP was first introduced in New Zealand and Denmark in 1972. GLP was instituted in US following cases of fraud generated by toxicology labs in data submitted to the FDA by pharmaceutical companies. Industrial BioTest Labs (IBT) was the most notable case, where thousands of safety tests for chemical manufacturers were falsely claimed to have been performed or were so poor that police investigators could not piece together what work had been done...even though IBT superficially delivered the test results their contracts with the manufacturers specified.

These issues were made public in the hearings at the US Congress, which led to the FDA’s publication of Proposed Regulations on GLP in 1976, with establishment of the Final Rule in June 1979 (21 CFR 58). The Environmental Protection Agency (EPA) had also encountered similar problems in data submitted to it, and issued its own draft GLP regulations in 1979 and 1980, publishing the Final Rules in two separate parts (40 CFR 160 and 40 CFR 792) in 1983.

The OECD

Following Decision C(97),186/Final of the OECD Council, data generated in the testing of chemicals in one OECD Member Country, in accordance with OECD Test Guidelines and the Principles of GLP are accepted in all other OECD Member Countries. OECD: EMV/MC/CHEM(98)17 part two

GLP is a quality system concerned with the organisational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.

GLP principles include

1. Organization and Personnel
   • Management-Responsibilities
   • Sponsor-Responsibilities
   • Study Director-Responsibilities
   • Principal Investigator-Responsibilities
   • Study Personnel-Responsibilities
2. Quality assurance program
   • Quality Assurance Personnel
3. Facilities
   • Test System Facilities
   • Facilities for Test and Reference Items
4. Equipment, reagents and Materials
5. Test systems
   • Physical/Chemical
   • Biological
6. Test & Reference items
7. Standard operating procedures
8. Performance of Study
   • Study Plan
   • Conduct of Study
9. Reporting of results
10. Archival - Storage of Records and Reports

OECD Guidelines for the Testing of Chemicals

OECD publishes OECD Guidelines for the Testing of Chemicals, which are guidelines that usually have to be followed for GLP compliance. They are widely required by agencies doing risk assessments of chemicals.

The US FDA

The United States FDA has rules for GLP in 21CFR58. Preclinical trials on animals in the United States of America use these rules prior to clinical research in humans.

Research in the US not conducted under these restrictions or research done outside US not conducted according to the OECD Guidelines (or FDA rules) might be inadmissible in support of a New Drug Application in the US.

European Union

Since 1987 the European Council had adopted two basic Directives and a Decision relating to the application of the GLP principles. Directive 2004/10/EC has replaced Directive 87/017/EEC as of 11 March 2004; Directive 2004/9/EC has replaced Directive 88/320/EEC as of 11 March 2004.

• " Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances."

This directive lays down the obligation of the Member States to designate the authorities responsible for GLP inspections in their territory. It also comprises requirements for reporting and for the internal market (i.e., mutual acceptance of data).

• " Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP)".

The Directive requires that the OECD Revised Guides for Compliance Monitoring Procedures for GLP and the OECD Guidance for the Conduct of Test Facility Inspections and Study Audits must be followed during laboratory inspections and study audits.

• 89/569/EEC Council Decision of 28 July 1989 on the acceptance by the European Economic Community of an OECD decision / recommendation on compliance with principles of good laboratory practice.

There are also 'Product Oriented Directives' referring to GLP obligations:

• REACH Regulation of 18 December 2006 and Directive 2006/121/EC of 18 December 2006
• Medicinal products; Directive 2001/83/EC on the Community code relating to medicinal products for human use of 6 November 2001 as amended by Commission Directive 2003/63/EC
• Veterinary Medicinal Products; Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products
• Cosmetics; Council Directive 93/35/EEC amending for the 6th time directive 76/768/EEC
• Feedingstuffs; Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition
• Foodstuffs; Directive 89/107/EEC
• Novel Foods and novel food ingredients; Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients
• Pesticides; Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market
• Biocides; Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market
• Detergents; Directive 98/8/EC Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents
• EC Ecolabel; Commission Decision 2005/344/EC of 23 March 2005; establishing ecological criteria for the award of the Community eco-label to all-purpose cleaners and cleaners for sanitary facilities

In the meantime the EU has concluded Mutual Acceptance Agreements in the area of GLP with Israel, Japan and Switzerland. By means of the Treaty of the European Economic Area of 13 September 1993, the European Regulations and Directives also apply to Iceland, Liechtenstein and Norway.

Non-OECD member countries

An inspection in non-member economies by OECD inspectors will not guarantee that data generated in compliance with GLP will be accepted in other member countries than the one to which they are submitting data and which has thus sent inspectors to verify the accuracy of their compliance statement.

Criticism

GLP regulations require adequately qualified personnel, adequate facilities, a single qualified study director for each study, a quality assurance unit, adequate test system care facilities, characterized test articles/test items, equipment that has been proven to perform as required and is adequately inspected, cleaned and maintained, standard operating procedures approved by management (not QA), proper documented care of test systems, a study protocol/plan with specified content approved by the study director, and a study report with specified content. The GLP regulations require documentation of any laboratory worksheets, records, memoranda, notes or exact copies thereof, that are the result of original observations and activities of a non-clinical laboratory study and are necessary for the reconstruction and evaluation of the report of that study and an archive for orderly storage and expedient retrieval of all raw data, documentation, protocols/plans, and specimens generated as the result of a non-clinical laboratory study.

Although it is good scientific practice to assure equipment is functioning properly, people are qualified, data are recorded properly, etc... Even though hundreds of facilities around the world, including developing countries, have demonstrated the capability to successfully perform GLP compliant studies, others continue to argue these good scientific practices are too difficult for them to satisfy. Some researchers make the argument that since studies that do not meet these quality standards may be published in peer reviewed scientific journals, good science may be performed without GLP compliance. It is accurate to state that compliance with GLP regulations does not assure good science. Since good and bad science may be performed GLP compliant or non-GLP, this argument misdirects the discussion from the reason why the GLPs are required: to protect public health and safety. Because the data and reports of non-clinical safety studies are used to make public health decisions, it is necessary that these studies can be reconstructed from data that has the integrity, and GLP ensures the integrity of the data.

Klimisch score

The Klimisch score system tries to rank the reliability of toxicity studies for use by risk assessors (regulatory agencies). It was published in 1997, by BASF (a chemical company) authors. Studies performed according to GLP are assigned the top rank of 1 (reliable without restriction) and are preferred by agencies. When no GLP study is available for a particular endpoint, a study with a rank of 2 is usually accepted by an agency. Lower ranks typically require a new study to be performed. Klimisch scoring is very widely used in chemical risk assessments. Critics say it is a self-interested bias on objectivity, that a quality system from the regulated party gives their own GLP-complying studies the top rank.

Automated systems

In many instances, the optimal recommended 'no-argument' means of implementing GLP is to develop an automated approach to both Sample Preparation and Sample Measurement. If this can include an overarching 'chain of custody' sample history and data flow, combined with adequate SOP's for calibration & linearization of measuring tools, GLP compliance is virtually assured.

Implementing GLP on an automated system, as an intellectual and labour-intensive task, requires a GxP company to make a great amount of effort. To ease the burden of this management, Webster et al. have provided a tutorial for users to quickly embark on and do the job properly.

Notes and references

See also

• GxP
• Good Automated Manufacturing Practice
• Joint Committee for Traceability in Laboratory Medicine
• International Laboratory Accreditation Cooperation
• International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)
• Drug development
• ISO 15189
• Verification and Validation
• Society of Quality Assurance

External links

• Comparison of difference versions of GLP (Comparison OECD, FDA and EPA GLP)
• Code of Federal Regulations Title 21 (Food and Drugs) Part 58 (Good Laboratory Practice for Non-clinical Laboratory Studies) (USA)
• Medicines and Healthcare products Regulatory Agency-UK (MHRA-UK definition of GLP)
• current Good Analytical Laboratory Practice [cGALP]
• Pharma Knowledge Park [PKP]
• Good Laboratory Practice (Organisation for Economic Co-operation and Development)
• OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring
• Belgian Monitoring Authorithy for GLP

UpToDate Contents

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English Journal

• Training of nurses in point-of-care testing: a systematic review of the literature.

• Liikanen E, Lehto L.SourceInstitute of Health Sciences, University of Oulu, Oulu and Senior Lecturer, Tampere University of Applied Sciences, Tampere, Oulu, Finland.
• Journal of clinical nursing.J Clin Nurs.2013 Aug;22(15-16):2244-52. doi: 10.1111/jocn.12235. Epub 2013 May 16.
• AIMS AND OBJECTIVES: To review and describe the training of nurses in point-of care testing.BACKGROUND: Point-of-care tests are usually carried out by nurses. They are used in many healthcare units. Through training, nurses are able to improve their competence in performing point-of-care testing.DES
• PMID 23679832

• ASCORE: an up-to-date cardiovascular risk score for hypertensive patients reflecting contemporary clinical practice developed using the (ASCOT-BPLA) trial data.

• Prieto-Merino D, Dobson J, Gupta AK, Chang CL, Sever PS, Dahlöf B, Wedel H, Pocock S, Poulter N.SourceDepartment of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
• Journal of human hypertension.J Hum Hypertens.2013 Aug;27(8):492-6. doi: 10.1038/jhh.2013.3. Epub 2013 Feb 14.
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• Changes in blood parameters in rhesus monkeys (Macaca mulatta) during the first trimester of gestation.

• Ibáñez-Contreras A, Hernández-Godínez B, Reyes-Pantoja SA, Jiménez-García A, Solís-Chavéz SA, Suarez-Gutiérrez R, Gálvan-Montaño A.SourceCentro de Investigación, Proyecto CAMINA, A.C., Ciudad de México, México D.F, México; BIOINVERT®, Biología Integral para Vertebrados, Unidad de Experimentación Animal, Mexico, México.
• Journal of medical primatology.J Med Primatol.2013 Aug;42(4):171-6. doi: 10.1111/jmp.12052. Epub 2013 Apr 26.
• BACKGROUND: Regarding the good practice in the laboratory work, it is essential to have a broad spectrum of biochemical and hematological references in pregnant females to determine the health status of the colony.OBJECTIVE: To establish reference values to reveal changes in hematology and blood che
• PMID 23617567

Japanese Journal

• Homogeneous Assays for LDL-C and HDL-C are Reliable in Both the Postprandial and Fasting State

• Ｊｏｕｒｎａｌ　ｏｆ　Ａｔｈｅｒｏｓｃｌｅｒｏｓｉｓ　ａｎｄ　Ｔｈｒｏｍｂｏｓｉｓ 24(6), 583-599, 2017
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• 「細胞培養における基本原則」の提案

• 組織培養研究 36(2), 13-19, 2017
• NAID 130005675467

• Impact of Hematopoietic Progenitor Cell Count as an Indicator for Optimal Timing of Peripheral Stem Cell Harvest in Clinical Practice

• Ｊｏｕｒｎａｌ　ｏｆ　Ｃｌｉｎｉｃａｌ　ａｎｄ　Ｅｘｐｅｒｉｍｅｎｔａｌ　Ｈｅｍａｔｏｐａｔｈｏｌｏｇｙ 56(3), 150-159, 2017
• NAID 130005465220

Related Links

• Good Laboratory Practice (GLP) - OECD

Data and research on test guidelines including chemical testing and assessment, chemical safety, animal welfare, endocrine disrupters, good laboratory practice (GLP), Mutual Acceptance of Data (MAD)., This is the OECD Good ...

• H A N D B O O K - WHO | World Health Organization

WHO Library Cataloguing-in-Publication Data Handbook: good laboratory practice (GLP): quality practices for regulated non-clinical research and development - 2nd ed. 1.Laboratories - organization and administration. 2.Laboratories ...

Related Pictures

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★リンクテーブル★

リンク元	「GLP」「優良実験室規範」「優良試験所基準」
関連記事	「practice」「go」「good」「practiced」「laboratory」

「GLP」

　　[★]

• グルカゴン様ペプチド、((略))(医薬品安全性試験基準)優良試験所基準、優良実験室規範

関

glucagon-like peptide、good laboratory practice

「優良実験室規範」

　　[★]

英

good laboratory practice、GLP

関

優良試験所基準、グルカゴン様ペプチド

「優良試験所基準」

　　[★]

英

good laboratory practice、GLP

関

優良実験室規範、グルカゴン様ペプチド

「practice」

　　[★]

• n.

• 実施、実行、実践、実際。経験。(数学)実算
• (個人の)習慣。(社会の)慣行、慣例、習わし
• (教会)礼拝式
• 練習、実習、稽古
• 熟練(skill)、手腕
• (医師・弁護士などの)業務、営業。事務所、診療所
• 患者、事件依頼人

• vt.
• vi.

関

care、carry out、clinical practice、conduct、cure、curing、custom、do、execute、execution、habit、habituation、implement、implementation、make、medical care、perform、performance、private practice、remediation、remedy、run、therapeutic、therapy、treat、treatment、undertake

　 　 　 　 　 　 　

「go」

　　[★]

• v.

• (過去went-過去分詞gone)行く、進む、し始める、及ぶ、なる

関

advance、become、come、extend、get、navigate、proceed、range、reach、span、turn

　 　 　 　 　 　 　 　 　 　 　 　 　 　 　

「good」

　　[★]

• adj.

• 優れた、良い

関

excellent、superior

　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　

「practiced」

　　[★]

• adj.

• 熟練の

関

experience、proficiency、proficient、skill、skilled、skillful

　

「laboratory」

　　[★]

• n.

• 研究室、実験室、検査室、ラボ

関

lab、labo