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GMP certification requirements in Chile, Cuba and Venezuela

Home/Reports | Posted 08/10/2021 0 Post your comment

The increasingly globalized nature of commerce allows manufacturers to outsource activities, such as procurement of raw materials overseas, where different regulatory requirements may exist. Thus, there is a need to ensure that the good manufacturing practices (GMP) guidelines adopted by the regulatory authorities (RAs) and international organizations (IOs) are harmonized and robust. A robust set of GMP guidelines helps in safeguarding public health by assuring the quality, safety and efficacy of the biopharmaceuticals [1].

Consideration must be given to certain steps such as legalization of documents and the period in project timelines when submitting documents for marketing authorization in several countries in Latin America. This also includes a wide range of GMP certification requirements and variation in the need to present certification for only one product or for intermediates of that product or active pharmaceutical ingredient (API).

The requirements to present GMP certificate in drug products marketing authorization submissions are very briefly described below for Chile, Cuba and Venezuela.

Chile and Cuba
Local authorities in these countries require the submission of GMP certificate for the drug product and accept the document issued by the authority of the country where the manufacturing site is located.

Venezuela
The regulatory body in charge of approving medicines in Venezuela is the National Institute of Hygiene Rafael Rangel (Instituto Nacional de Higiene Rafael Rangel, INHRR).

INHRR requires the presentation of GMP certificate for the drug product and accepts the document issued by the authority of the country where the manufacturing site is located.

Considering local experience, although not defined in the requirements checklist, presentation of the API GMP certificate was required for a new molecule in the country.

This article is the last of a series of four articles on the certification of GMP requirements in different countries in Latin America.

GMP certification requirements in Andean Community countries

GMP certification requirements in Argentina, Brazil and Mexico

Biopharmaceuticals and biosimilars: manufacturing challenges

Biopharmaceuticals and biosimilars: challenges in manufacture, regulation and international harmonization of GMP

LATIN AMERICAN FORUM The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View this week’s headline article: Requisitos de certificación de BPF en Chile, Cuba y Venezuela Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Vea el artículo principal de esta semana: Requisitos de certificación de BPF en Chile, Cuba y Venezuela Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.

Reference
1. U.S. Food and Drug Administration. Facts about the current good manufacturing practices (CGMPs). 2018 [homepage on the Internet]. [cited 2021 Oct 8]. Available from: https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps

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