When we look at the articles of GLP Good Laboratory Practices System, the scope of this standard is understood. Below are the items of the system:

  • Organizational structure of laboratories and employees
  • Quality Assurance Program
  • Facilities
    • Laboratory environment
    • Test system installations
    • Concerning the use of test and reference materials
    • Archive units
  • Disposal of waste

·         Tools, materials and reagents

    • Tools and materials
    • Reagents
  • Test systems
    • Physical or chemical test systems
    • Biological testing systems

·         Test and reference materials

    • Receipt, processing, sampling and storage of test and reference materials
    • Determination of properties of test and reference materials
  • Standard working methods
    • General requirements
    • Application
  • Working performance
    • Planning and conducting the study
    • Contents of the work plan
    • Conducting the study
  • Reporting of study results
    • General considerations
    • Contents of the final report
  • Storage and retention of records and material
    • Archives
    • Retention
  • Studies with experimental animals
  • Audit

Laboratories must have a written quality assurance program in order to carry out their activities in accordance with the principles of the GLP Good Laboratory Practices System. The quality assurance program is carried out by a person or persons assigned by the management who is directly responsible to the management, who also understands laboratory activities.

Laboratoriesmust be large enough to meet the requirements of the test studies. The working environment should not be detrimental to the validity of the work. At the same time, laboratories should be isolated from potentially harmful substances. Separate areas should be available for the collection and storage of test and reference materials to prevent interference or contamination. There should also be archive areas where raw data, reports and samples will be stored.

In the Good Laboratory Practices System, there are detailed standards for the Quality Assurance Program and other topics covered in addition to these issues which are briefly explained for the laboratory environments.

Laboratories wishing to have the GLP Good Laboratory Practices System Certificate may apply to experienced managers and employees of the TURCERT certification body for further clarification of the standards and scope of the system.