GOOD LABORATORY PRACTICE (GLP)

OECD's Work on Good Laboratory Practice (GLP) and Compliance Monitoring

OECD's Work on GLP The OECD Principles of Good Laboratory Practice were recently revised in 1997, and are available for downloading in portable document format or in Word 6 format. 


OECD's Environmental Health and Safety publications (Good Laboratory Practice and Compliance Monitoring )

OECD's Guidelines for the Testing of Chemicals (List of OECD Chemical Test Guidelines)

Other OCDE GLP related documents

OCDE Search

EUR-LEX (European Legislation)  

The Revised Principles of Good Laboratory Practice of the Organisation for Economic Cooperation and Development-Changes, Chances, and Controversies - DIA (Volume 34, Issue 1 (January-March) 2000)

UK Department of Health (DH)

Good Laboratory Practice - Index

Good Laboratory Practice - Good Laboratory Practice Monitoring Authority Code of Practice

Good Laboratory Practice - Good Laboratory Practice: Advisory Leaflet Number One - The Application of GLP Principles to Computer Systems Code of Practice

Good Laboratory Practice - Good Laboratory Practice: Advisory Leaflet Number Two - The Application of GLP Principles to Field Studies Code of Practice

Good Laboratory Practice - Good Laboratory Practice: Advisory Leaflet Number Three - Good Laboratory Practice and the Role of Quality Assurance

Good Laboratory Practice - Good Laboratory Practice: Advisory Leaflet Number Four - Good Laboratory Practice and the Role of the Study Director

Good Laboratory Practice - The Application of the Principles of Good Laboratory Practice to Safety Studies on Biological Substances

 

INFARMED / IPQ (Acordo nº 5666/97) - Portugal

Certificação em Boas Práticas de Laboratório, de acordo com os Princípios da OCDE, para a área dos medicamentos e da cosmética

Procedimento de Candidatura

Laboratórios Portugueses com Certificação BPL

LEGCOM - Legislação Nacional e Europeia Sobre BPL

EUR-LEX - Directiva 88/320/CEE do Conselho de 9 de Junho de 1988 relativa à inspecção e verificação das boas práticas de laboratório (BPL)

EUR-LEX - Directiva 1999/12/CE da Comissão de 8 de Março de 1999 que adapta pela segunda vez ao progresso técnico o anexo da Directiva 88/320/CEE do Conselho relativa à inspecção e verificação das boas práticas de laboratório (BPL) (Texto relevante para efeitos do EEE)

EUR-LEX - Directiva 87/18/CEE do Conselho de 18 de Dezembro de 1986 relativa à aproximação das disposições legislativas, regulamentares e administrativas respeitantes à aplicação dos princípios de boas práticas de laboratório e ao controlo da sua aplicação para os ensaios sobre as substâncias químicas

EUR-LEX - Directiva 1999/11/CE da Comissão de 8 de Março de 1999 que adapta ao progresso técnico os princípios de boas práticas de laboratório, conforme previsto na Directiva 87/18/CEE do Conselho relativa à aproximação das disposições legislativas, regulamentares e administrativas respeitantes à aplicação dos princípios de boas práticas de laboratório e ao controlo da sua aplicação para os ensaios sobre as substâncias químicas (Texto relevante para efeitos do EEE)

Decreto-Lei Nº 95/2000 de 23 de Maio

Decreto-Lei Nº 99/2000 de 30 de Maio

 

Other GLPs related sites

The University of Georgia's Quality Assurance Unit FDA Documents; EPA Documents; Good Clinical Practices; Good Manufacturing Practices; etc

Good Laboratory Practices - Online

 

Good Manufacturing Practice  (GMP)

FDA Current Good Manufacturing Practice (CGMP) Regulations: Division of Manufacturing and Product Quality (HFD-320) 

(21 Code of Federal Regulations - Parts 210 and 211)  

Human Drug CGMP Notes 

21 CFR Part 11; Electronic Records; Electronic Signatures

 

In-Process Changes to the CGMP Regulations

Federal Register Notice Proposed Rule, Proposed Changes to the CGMP Regulations about Validation, Out-of-Specification Findings, etc. (5/3/96)

Federal Register Notice Final Rule, Partial, Extension of Compliance Date, (7/29/97); or Acrobat Version

Federal Register Notice Proposed Rule, Revision of Certain Labeling Controls (7/29/97); or Acrobat Version

EU Guide to Good Manufacturing Practice

VOLUME 4 - Good Manufacturing Practices

Commission Directive 91/356/EEC, of 13 June 1991, laying down the principles and guidelines of good manufacturing practice for medicinal products for human use

Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products.

INFARMED - Portugal

Guia para o bom fabrico de medicamentos

Other GMP related Documents

ECA - Guidelines

Good Pharmacy Practice guidelines   (GPP)

FIP - Pharmacy Practice Guidelines (Standards for Quality of Pharmacy Services)

FIP - Good Practice in Donation of Medicines

Download Draft 5 Copy of ISO/IEC Guide 25 MS Word 97 Document

Download Draft Copy of DIS/ISO 17025 MS Word 97 Document

General Requirements for the Competence of Calibration and Testing Laboratories

What's new and how it will impact analytical laboratories?

Standards Organizations / Standardizing Bodies / Acreditation Bodies

• (ANSI) - The American National Standards Institute
• (AOAC) - AOAC International
• (ASTM) - The American Society for Testing and Materials
• (BIPM) - Bureau International des Poids et Mesuress
• (BSi) - British Standards Institute
• (CEN) - CEN - European Committee for Standardization
• (CENELEC) - CENELEC - European Committee for Electrotechnical Standardization
• (CIE) - International Commission on Illumination
• (EA) - European co-operation for Accreditation
• (EC) - European Union
• (ECA) - European Compliance Academy
• (ECMA) - Standardizing Information and Communication Systems
• (EIA) - Electronic Industries Association
• (EMAS) - European Eco Management & Audit Scheme
• (EOQ) - European Organization for Quality
• (EOTC) - European Organization for Testing and Certification
• (ETSI) - European Telecommunications Standards Institute
• (EUROLAB) - EUROLAB Denmark
• (IAEA) - IAEA - International Atomic Energy Agency
• (IEC) - International Electrotechnical Comission
• (IEEE) - Institute of Electrical and Electronics Engineers Standards
• (IMEKO) - International Measurement Confederation
• (IMO) - IMO - International Maritime Organization
• (InstMC) - British Institute of Measurement and Control
• (IOE) - OIE - International Office of Epizootics
• (ISO) - The International Organization for Standardization
• (ITU-T) - International Telecommunication Union Telecommunication Standardization Sector
• (NCCLS) - National Committee for Clinical Laboratory Standards
• (NCSL) - US National Conference of Standards Laboratories
• (NSSN) - , National Standards System Network
• (OECD) - Organisation for Economic Co-operation and Development
• (OIML) - OIML - International Organization of Legal Metrology
• (UNESCO) - UNESCO - United Nations Educational, Scientific, and Cultural Organization
• (USCEL) - US Council of EMC Laboratories
• (WHO) - WHO - World Health Organization
• (WIPO) - WIPO - World Intellectual Property Organization

Organizations and Associations for Quality

• (AEC) - Spanish Association for Quality - (Asociación Española para la Calidad)
• (AOC) - Australian Organisation for Quality
• (APQ) - Portuguese Association for Quality - (Associação Portuguesa para a Qualidade)
• (ASQ) - American Society for Quality
• (ASTD) - American Society for Training and Development
• (DGQ) - German Society for Quality - (Deutsche Gesellschaft für Qualität)
• (EFQM) - European Foundation for Quality Management
• (EOC) - European Organization for Quality
• (JSQA) - Japan Society of Quality Assurance
• (NFK) - Norwegian Society for Quality - (Norsk Forening for Kvalitet)
• (ÖVQ) - Austrian Association for Quality - (Österreichische Vereinigung für Qualititätssicherung)
• (SLY) - Finnish Quality Association - (Suomen Laatuyhdistys)
• (SQA) - Society for Quality Assurance
• (VCK) - Vlaams Centrum voor Kwaliteitszorg

National standards bodies

Bodies having recognized activities in standardization; that are recognized at the national level; that have as a principal function, by virtue of their statutes, the preparation, approval or adoption of standards that are made available to the public; and that are eligible to be the national members of the corresponding international and regional standards organizations.

Argentina

• (AIRES) - Argentine Accredition Body

Australia

• (CSIRO) - Commonwealth Scientific and Industrial Research Organisation
• (NATA) - National Association of Testing Authorities
• (SAA) - Standards Australia

Austria

• (ON) - Österreichisches Normungsinstitut
• (BmWA) - Bundesministerium für wirtschaftliche Angelegenheiten

Belgian

• (BELTEST) - Belgian Accreditation Organisation for Testing Laboratories

Brazil

• (ABNT) - Associação Brasileira de Normas Técnicas

• (INMETRO) - National Institute for Metrology Standardization and Industrial Quality

Canada

• (SCC) - Standards Council of Canada

• (INMS) - NRC Institute for National Measurement Standards

China

• (CNACL) - China National Accreditation Committee of LAboratories

Colombia

• (ICONTEC) - Instituto Colombiano de Normas Técnicas y Certificación

Croatia

• (DZNM) - State Office for Standardization and Metrology

Czech

• (CAI) - Czech Accreditation Institute

Denmark

• (DS) - Dansk Standard
• (DFM) - Danish Institute of Fundamental Metrology
• (DANAK) - Danish Accreditation body

Egypt

• National Laboratories Accreditation Bureau - National Institute for Standards

Finland

• (SFS) - Finnish Standards Association
• (FINAS) - Finnish Accreditation Service

France

• (LNE) - Laboratoire National d'Essais
• (COFRAC) - Comité Français d'Accréditation
• (AFNOR) - Association française de normalisation

Germany

• (DIN) - Deutsches Institut für Normung
• (PTB) - Physikalisch - Technische Bundesanstalt
• (DAR) - Deutscher AkkreditierungsRat

Greece

• (ELOT) - Hellenic Organization for Standardization

Guatemala

• (COGUANOR) - Comisión Guatemalateca de Normas

Hong Kong

• (HOKLAS) - Laboratory Accreditation Scheme

Hungary

• (MSZT) - Magyar Szabványügyi Testület

Iceland

• (STRI) - Icelandic Council for Standardization

Ireland

• (NAB) - National Accreditation Board
• (NML) - National Metrology Lab
• (NETC) - National Electronics Technology Centre
• (NSAI) - National Standards Authority of Ireland

Israel

• (ISRAC) - Laboratory Accreditation Body

Italy

• (UNI) - Ente Nazionale Italiano di Unificazione
• (SINAL) - Sistema Nazionale di Accreditamento Laboratori
• (SINCERT) - Accreditamento Organismi Certificazione
• (SIT) - Servizio di Taratura in Italia

Japan

• (STA) - Science & Technology Agency
• (JISC) - Japanese Industrial Standards Committee
• (JIS) - Industrial Standards
• (JCSS) - Japan Calibration Service System
• (JABCA) - Japan Accreditation Board for Conformity Assessment

Korea

• (KRISS) - Korea Research Institute of Standards and Science

Malaysia

• (SIRIM) - Standards & Industrial Research Institute
• (DSM) - Department of Standards Malaysia

Mexico

• (ANSE - SINLAP) - Sistema Nacional de Acreditamiento de Laboratorios de Pruebas

Morocco

• (SNIMA) - Service de normalisation industrielle marocaine

Netherlands

• (RvA) - Dutch Raad voor Accreditatie
• (NNI) - Nederlands Normalisatie-Instituut

New Zealand

• (TELARC) - Testing Laboratory Registration Council
• (SNZ) - Standards New Zealand

Norway

• (NSF) - Norges Standardiseringsforbund
• Norwegian Accreditation

Peru

• (INDECOPI) - Instituto Nacional de Defensa de la Competencia y de la Protección de la Propiedad Intelectual

Philippines

• (BPSLAS) - Bureau of Product Standards Laboratory Accreditation Scheme

Poland

• Polish Centre for Testing and Certification Accreditation Office

Portugal

• (SPQ) - Sistema Português da Qualidade
• (IPQ) - Instituto Português da Qualidade
• (CNQ) - Concelho Nacional da Qualidade
• (ISQ) - ISQ - Instituto da Soldadura e Qualidade
• (INFARMED) - Instituto Nacional da Farmácia e do Medicamento
• (RELACRE) - Associação dos Laboratórios Acreditados

Romania

• Romanian Testing Laboratories Network

Russian Federation

• (GOST-R) - State Committee of the Russian Federation for Standardization, Metrology and Certification

Saudi Arabia

• (SASO) - Saudi Arabian Standards Organization

Singapore

• (PSB) - Singapore Productivity and Standards Board
• (SISIR) - Institute of Standards and Industrial Research

Slovakia

• (SNAS) - Slovak National Accreditation System

Slovenia

• (USM - SMIS) - Standards and Metrology Institute

South Africa

• (NML) - National Metrology Lab
• (SABS) - South African Bureau of Standards
• (SANAS) - South African National Accreditation Service

Spain

• (AENOR) - Asociación Española de Normalización y Certificación
• (ENAC) - Entidad Nacional de Acreditación

Sri Lanka

• Sri Lanka Standards Institution

Sweden

• (SIS) - Standardiseringen i Sverige
• (SWEDAC) - Swedish Board for Accreditation and Conformity Assessment

Switzerland

• (SNV) - Swiss Association for Standardization
• (SAS) - Swiss Accreditation Service

Thailand

• (TISI) - Thai Industrial Standards Institute
• (CNLA) - Chinese National Laboratory Accreditation Program

Trinidad / Tobago

• (TTBS) - Trinidad and Tobago Bureau of Standards
• (TTAS) - Trinidad and Tobago Laboratory Accreditation System

Turkey

• National Council for Quality and Accreditation

United Kingdom

• (BSI) - British Standards Institution
• (UKAS) - United Kingdom Accreditation Service
• (NPL) - National Physics Laboratory

USA

• (ANSI) - American National Standards Institute
• (NIST) - US National Institute of Standards & Technology
• (NVLAP) - National Voluntary Laboratory Accreditation Program
• (A2LA) - American Association for Laboratory Accreditation

Vietnam

• (STAMEQ) - Directorate for Standards and Quality

Quality Related Publications, Journals and Other Documents

• Accreditation and Quality Assurance - Springer LINK

• BioPharm - Advanstar

• EA Publications - EA

• Eurachem - Publications

• European Quality - EOQ

• GMP Trends

• Gold  Sheet

• Journal of GMP Compliance Technology - IVT

• Journal of Validation Technology - IVT

• LC-GC Magazine - Advanstar

• Quality Assurance - Taylor & Francis

• Quality Digest

• Quality Magazine

• Quality Progress - ASQ

• Quality Today

• Publicações - RELACRE

• PICs - Pharmaceutical Inspection Cooperation Scheme and the Pharmaceutical Inspection Convention - Publications

• The Quality Assurance Journal - Wiley

• The Quality Observer

• Total Quality Management Magazine - MCB University Press

• Validation Times
• Publicações do IPQ (Normas , Outras, Downloads)

Quality related Discussion Groups

• Cayman Systems QS9000 and ISO9000 Forums

• GMP Discussion Forum

• Forum: General Quality Issues - (NETView)

• E-mail List Discussion of ISO 9000 Revisions for the Year 2000 - (ISO 9000 Support Group)

• ISO Guide 25 Discussion List

• New LabCompliance Discussion Forum

• Quality Assurance Issues for Analytical Laboratories

• Quality Mangament Principles Forum

Other Quality Related Sites