GLP, Good Laboratory Practices

About GLP & cGLP

GLP is a quality management system that addresses the organizational processing process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. GLP ensures the quality, integrity, and reliability of safety data. GLP principles include:

  1. Organization and Personnel
    -Management
    -Responsibilities
    -Sponsor-Responsibilities
    -Study Director-Responsibilities
    -Principle Investigator-Responsibilities
    -Study Personnel
    -Responsibilities
  2. Quality assurance program
    -Quality Assurance Personnel
  3. Facilities
    -Test System Facilities
    -Facilities for Test and Reference Items
  4. Equipments, reagents and Materials

  5. Test systems
    - Physical/Chemical
    - Biological
  6. Test & Reference items

  7. Standard operating procedures

  8. Performance of Study

    -Study Plan
    - Conduct of Study
  9. Reporting of results

  10. Storage of Records and Reports

GLP and the FDA:

The United States FDA has rules for GLP in 21CFR58. Preclinical trials on animals in the United States of America use these rules prior to clinical research in humans. Research in the US not conducted under these restrictions or research done outside US not conducted according to the OECD Guidelines (or FDA rules) might be inadmissible in support of a New Drug Application in the US.

GLP and the European Union: Since 1987 the European Council had adopted two basic Directives and a Decision relating to the application of the GLP principles. Directive 2004/10/EC has replaced Directive 87/017/EEC as of 11 March 2004; Directive 2004/9/EC has replaced Directive 88/320/EEC as of 11 March 2004.

Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances."

To become GLP compliant you would need to train your staff to the requirements and implement the good laboratory pratcices throughout your operation.

 

GLP, GLP Training, cGLP, cGLP Training



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