BOAS PRÁTICAS DE LABORATÓRIO
Legislação Nacional
Os decretos-lei nacionais estão disponíveis em:
A aplicação do programa nacional de cumprimento das BPL no IPQ encontra-se descrita no:
Princípios BPL da OCDE; Guias e Documentação associada
As publicações da OCDE abaixo mencionadas podem ser obtidas no site da OCDE:
- OECD Principles of Good Laboratory Practice (as revised in 1997). 1998
- Guidance for GLP Monitoring Authorities: Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice. 1995
- Guidance for GLP Monitoring Authorities: Revised Guidance for the Conduct of Laboratory Inspections and Study Audits. 1995
- GLP Consensus Document: Quality Assurance and GLP. 1999
- GLP Consensus Document: Compliance of Laboratory Suppliers with GLP Principles. 1999
- GLP Consensus Document: The Application of the GLP Principles to Field Studies. 1999
- GLP Consensus Document: The Application of the GLP Principles to Short-term studies. 1999
- GLP Consensus Document: The Role and Responsibilities of the Study director in GLP Studies. 1999
- Guidance for GLP Monitoring Authorities: Guidance for the Preparation of GLP Inspection Reports. 1995
- GLP Consensus Document: The Application of the Principles of GLP to Computerised Systems. 1995
- Advisory Document of the Panel on Good Laboratory Practice: The Role and Responsibilities of the Sponsor in the Application of the Principles of GLP. 1998
- Advisory Document of the Working Group on Good Laboratory Practice: Requesting and Carrying out Inspections and Study Audits in Another Country. 2000
- Consensus Document of the Working group on Good laboratory Practice: The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies. 2002
- Advisory document of the Working group on Good Laboratory Practice “The Application of the Principles of GLP to in vitro studies” ENV/JM/MONO(2004)26
- Establishment and Control of Archives that Operate in Compliance with the Principles of GLP
- The Use of Laboratory Accreditation with reference to GLP Compliance Monitoring
- Outsourcing’ of Inspection Functions by GLP Compliance Monitoring Authorities
- Mutual Acceptance of Data (MAD)
Documentos da União Europeia