Good Laboratory Practices

Good Laboratory Practices (GLP) is a quality assurance system that includes the conditions and management procedures for planning, monitoring, recording, archiving and reporting of health and environmental research other than clinical research.

Non-clinical health and environmental safety studies within the scope of ILU principles can be performed under laboratory conditions, greenhouses and on the site. Our GLP program covers all test and chemical groups. By testing these substances, data regarding the safety of these substances for human health and / or the environment is able to obtain.

Test facilities that are willing to be in the Good Laboratory Practices Conformity Monitoring Program are assessed according to FDA, WHO, EUDRALEX, Good Laboratory Practices and Compliance Monitoring Principles, Good Laboratory Practices Principles, Harmonization of Test Units, Regulation on Good Laboratory Practices and Inspection of Studies and QUALYNONE Procedures and then the GLP Declaration of Conformity is given to the appropriate test facilities.

Mandatory Documents

  • QUALYNONE P901 - Good Laboratory Practice Compliance Monitoring Programme
  • QUALYNONE P902- Appeal Procedure for  GLP Compliance Monitoring Process
  • QUALYNONE Q901-01 - GLP Definitions and Abbreviations Instruction
  • Regulation on Good Laboratory Practice Principles, Harmonization of Test Units, Supervision of Good Laboratory Practices and Studies.

Guidance Documents / Other Related Documenta

  • FDA
  • WHO
  • EUDRALEX
  • OECD No 8 - The Role and Responsibilities of the Study Director in GLP Studies
  • OECD No 10 -The Application of the Principles of GLP to Computerised Systems
  • OECD No 11 - The Role and Responsibility of the Sponsor in the Application of the Principles of GLP
  • OECD No 12 - Requesting and Carrying Out Inspections and Study Audits in Another Country
  • OECD No 13 - The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies
  • OECD No 14 - The Application of the Principles of GLP to in vitro Studies
  • OECD No 15 - Establishment and Control of Archives that Operate in Compliance with the Principles of GLP
  • OECD No 17 Application of GLP Principles to Computerised Systems
  • OECD No 18 - OECD Position Paper Regarding the Relationship between the OECD Principles of GLP and ISO/IEC 17025
  • OECD No 19 - Management, Characterisation and Use of Test Items
  • OECD No 21 - OECD Position Paper Regarding Possible Influence of Sponsors on Conclusions of GLP Studies
  • OECD No 22 - GLP Data Integrity

OECD No 23- Quality Assurance and GLP