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GOOD LABORATORY PRACTICE
(GLP)
OECD's Work on Good Laboratory
Practice (GLP)
and
Compliance Monitoring
UK Department of Health (DH)
Good
Laboratory Practice - Index
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
MHW GLPs - Japan
FDA GLP regulations
(21 CFR Part
58)
- Complete FDA GLP Document - 21 CFR PART 58 - Food and Drug Administration
Friday, September 4, 1987
Other GLPs related sites
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
Organizations and
Associations for Quality
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
Austria
Belgian
Brazil
Canada
China
- (CNACL) - China National Accreditation Committee of LAboratories
Colombia
Croatia
Czech
- (CAI) - Czech Accreditation Institute
Denmark
Egypt
- National Laboratories Accreditation Bureau - National Institute
for Standards
Finland
France
Germany
Greece
Guatemala
- (COGUANOR) - Comisión Guatemalateca de Normas
Hong Kong
Hungary
Iceland
Ireland
Israel
Italy
Japan
Korea
Malaysia
Mexico
Morocco
Netherlands
New Zealand
Norway
Peru
Philippines
- (BPSLAS) - Bureau of Product Standards Laboratory Accreditation Scheme
Poland
- Polish Centre for Testing and Certification Accreditation Office
Portugal
Romania
- Romanian Testing Laboratories Network
Russian Federation
Saudi Arabia
Singapore
Slovakia
- (SNAS) - Slovak National Accreditation System
Slovenia
South Africa
Spain
Sri Lanka
Sweden
Switzerland
Thailand
Trinidad / Tobago
Turkey
United Kingdom
USA
Vietnam
- (STAMEQ) - Directorate for Standards and Quality
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