The Organization for Economic Co-operation and Development (OECD) is an organization of international cooperation, which aims to coordinate their economic and social policies to exchange information and harmonize them with the aim of maximizing their economic growth and contribute to its development and the non-members too.
As part of the exchange of information and compliance with its objective, in 1978 the principles of good laboratory practices were developed and updated in 1997, aims to promote quality and validity of test data used to establish the safety of chemicals. GLP is a quality assurance system on the mode of organization of non-medical safety studies related to health and the environment. It means, how are planned, executed, monitored, recorded, archived and disseminated and are basis of mutual acceptance of data (MAD) between the various member countries.
The scope of GLP are studies of non-medical safety pharmaceuticals, pesticides, cosmetics, veterinary drugs, additives for human and animal consumption, industrial chemicals developed in laboratory, greenhouse or field.
- Physical and Chemical Testing
- Toxicity studies
- Mutagenicity studies
- Environmental toxicity studies in terrestrial and aquatic organisms
- Studies on behavior in water, soil and air; bioaccumulation
- Residue studies
- Studies on the effects of natural ecosystems mesocosmosy
- Analytical and medical chemistry tests
- Other specified studies
By official document DGN.312.01.2013.4068 issued December 3, 2013, the Ministry of Economy through the General Directorate of Standards issues permission to Mexican accreditation entity, acas an independent agency delegated to evaluate and certify compliance with the principles of Good Laboratory Practice non medical tests in the country.
The inspection is carried out based on the documents provided by the OCDE.
Some of the potential benefits of applying GLP.
- Avoid unnecessary conflicts or duplications for the risk assessment of products that are marketed in more than one country, generating savings of resources for industry, government and consumers as a whole.
- Participation in the global market as an evaluation services provider (MAD).
- Avoid duplication of procedures with countries that have implemented mutual acceptance of data according to GLP.
- Decrease in the number of animals and insects involved in studies, promoting animal welfare.
- It promotes the participation of Mexican industries in the global economy.
The adoption of procedures for assessing the conformity, harmonization and standardization of data and information developed as GLP; will boost the development of Mexican industries.
Based on the potential benefits of implementing the program, the Ministry of Economy through the General Directorate of Standards issues the authorization to the Mexican accreditation entity as an independent body delegated to evaluate and certify compliance with the principles of Good Laboratory Practices of non-clinical trials in national territory, being then responsible for issuing certificates of compliance as well as working together and notifying regulatory authorities of the result of Inspections or audited studies.
