ONAC - National Good Laboratory Practice Monitoring Program
Programa Nacional de Monitoreo de las Buenas Practicas de Laboratorio – ONAC
In the framework of Colombia’s accession process to the OECD, initiated in September 2013, the National Accreditation Body of Colombia – ONAC has been designated by the Government as the National Authority for Monitoring Good Laboratory Practices – GLP.
Decree 1595 of August 5, 2015, issued by the Ministry of Commerce, Industry and Tourism of Colombia, establishes in Chapter 7, Section 7, Art. 2.2.1.7.7.7.6 – Inc. 15, that ONAC shall: “Act as National Monitoring Authority – NMA in Good Laboratory Practices – GLP of the Organization for Economic Cooperation and Development – OECD”.
As National GLP Monitoring Authority, ONAC is in charge of monitoring the adequate compliance with Good Laboratory Practices – GLP in the testing facilities in the country and to perform other functions, which may be determined at the national level, related to these GLP.
ONAC, in compliance with its functions, established the National GLP Monitoring Program. This program defines the general framework for monitoring compliance with Good Laboratory Practice by testing entities in each country, as defined by the OECD, involving a particular scheme of inspections and audits of studies.
Good Laboratory Practice is a quality system that addresses the organizational process and conditions under which non-clinical environmental health and safety studies conducted by Testing Entities are planned, performed, monitored, recorded, archived and reported.
GLP under OECD principles is a quality system that assesses the safety of chemical products that require registration for use and marketing and is part of Colombia’s OECD agenda, in which a registry is prepared to characterize all chemical substances that are produced and marketed.
Mutual Data Acceptance – MAD (MAD) is the Agreement adopted by the OECD Council in Decision C(81)30/FINAL in 1981, stating that test data generated in any member or adhering country shall be fully accepted by the OECD Council, in accordance with OECD test guidelines and Principles of Good Laboratory Practice (GLP), are accepted in full member or adhering countries for evaluation purposes and other uses related to the protection of human health and the environment.
Currently ONAC is in the process of recognition by the OECD, with the purpose of making Colombia one of the full adherents to the AMD of this organization. Undoubtedly this will bring multiple benefits for the country, in terms of marketing of such substances, within or outside the national territory, with the other member or full adherent countries of this agreement. Thanks to this, it will not be necessary to duplicate the tests in the country of destination of the substances.
Below you will find the laboratories recognized by ONAC under OECD Good Laboratory Practice (GLP) principles
Code: 18-BPL-001
Date of recognition: July 15, 2019
Expiration Date: Expired Status
Address: Carrera 48A No. 61 South No. 75 Office 401
City: Sabaneta, Antioquia
Phones: 6049303- 316 830 3871
Web: www.deliverytechnologies.com.co
E-mail address:
servicioalcliente@deliverytechnologies.com.co
alejandro.olaya@deliverytechnologies.com.co
Expired Status.
Code: 18-BPL-002
Date of recognition: July 15, 2019
Expiration Date: Status Pending
Address: Transversal 60 No 115-58 Torre a Oficina 307
City: Bogota
Phones: 6240399
Web: www.inmunopharmos.com
E-mail address:
inmunopharmos@yahoo.com
Pending Status
Pending Status: State in which the recognized entity cannot declare that a study is conducted under OECD GLP until compliance with the OECD GLP Principles is assured, in which the contract for the granting and use of the OECD GLP Certificate of Recognition signed by the entity and ONAC remains in force.
Verify the status of an accreditation by typing the accreditation code below:
Documentos adicionales o complementarios de la norma de acreditación, para algunos alcances específicos, que el solicitante debe cumplir y son objeto de evaluación por parte de ONAC para determinar su competencia como Organismo Evaluador de la conformidad.
Conoce las reglas y los requisitos para acreditarte como Productor de Materiales de Referencia:
Requisitos que debe cumplir el solicitante que desea acreditarse de acuerdo con el esquema de evaluación de la conformidad y que son objeto de evaluación para determinar la competencia del organismo. ejemplo ISO 17034 requisitos para Productores de materiales de referencia.
Los documentos ILAC suministran información que puede apoyar la implementación de los requisitos establecidos en la norma ISO 17034. Los documentos R (Reglas) y P (Políticas) de ILAC contienen requisitos mandatorios para los OEC que buscan la acreditación con ONAC. Los documentos G (guías) son de carácter informativo, aunque una vez son acogidas por los OEC, se tornan obligatorias.
Aplican para todos los esquemas de acreditación y definen condiciones desde la presentación de la solicitud hasta el mantenimiento y renovación de la acreditación, forman parte de la relación contractual con ONAC.
