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A look at why Brazil revised its GMP standards and how the changes will affect the local pharmaceutical industry.
On April 19, 2010, Brazil's regulatory health authority, Anvisa, revised its good manufacturing practice (GMP) requirements, replacing standards that had been in place since August 2006. The GMPs apply to pharmaceutical products negotiated within the Mercado Común del Sur/Mercado Comum do Sul (Mercosul or Mercosur), the regional trade agreement that includes Argentina, Brazil, Paraguay, Uruguay, and Venezuela. (Bolivia, Chile, Colombia, Ecuador and Peru currently have associate member status.)
PHOTO: JEREMY WOODHOUSE, DIGITAL VISION, GETTY IMAGES
The purpose of GMPs is to establish minimum requirements and standard practices to be followed in the manufacturing of drugs. Anvisa's revised GMP document, known as RDC 17, which applies to all drugs manufactured domestically for human use, took effect upon publication in April 2010. The document addresses quality, sanitation and hygiene, qualification and validation, products and contracts, and more. The primary updates affect computer-system validation and periodic product revision. Other specific changes address biological products, water for pharmaceutical uses, sterile products, and herbal medicines, according to the Rio de Janeiro Pharmacy Council.
"The quality of a certain drug is directly related, among other aspects, with practices used during its production," said Anvisa Inspection Manager Marcelo Vogler. "These rules are fundamentally important for Anvisa because they guarantee certain quality requirements for drugs available in the local market."
"The [GMP] rules are a result, mainly, of [global] disasters and catastrophes caused by faulty production practices as well as bad use and commercialization of pharmaceutical drugs," explains Vogler.
During the 20th century, inspection problems and quality issues with pharmaceutical drugs led to many deaths and serious health injuries.
One of the first major crises involved the use of elixir sulfanilamide. The ingredient was improperly used in a drug product and caused a mass poisoning in the United States in 1937. This incident, among others, led to the passing of the 1938 US Federal Food, Drug, and Cosmetic Act to secure the supply chain of these products. In Brazil, the act was introduced mainly as a consequence of the Mercosur trade pact and the need to consolidate trade practices, according to Anvisa.
Then, in 1961, the sedative Thalidomide was withdrawn after it was discovered to cause birth defects in children whose mothers took the drug during pregnancy. Said to be "one of the biggest medical tragedies of modern times," the thalidomide case led to much stricter testing requirements for drugs worldwide.
"The Mercosur pact brought the need to establish a package of harmonized rules between the members in order to support the process being developed," explained Vogler.
Why revise the GMPs now? According to Vogler, all revisions to Brazil's pharmaceutical GMPs, including the most recent RDC 17 resolution, are based on international references, including standards set by the World Health Organization (WHO).
"WHO revises its recommendations periodically and, consequently, we follow such recommendations, and that is why there was the need to revise our national document as well," said Vogler.
"The main changes [to RDC 17] regard the need to 'Validate Computerized Systems' related with the process of production of pharmaceutical drugs," says Henrique Tada, technical regulatory manager in Brazil for the National Pharmaceutical Laboratories Association (Alanac) in Brazil.
According to Tada, the revised GMPs on computer validation and product revision are beneficial because they force pharmaceutical companies to comply with quality controls in order to supply the local market with high quality drugs. The changes will also help bring Brazil's pharmaceutical drug manufacture in line with regulatory standards of the most developed countries. (The revised GMP on validating computer systems used in the production of drugs will involve additional costs for companies and as a result, will not be enforceable for three years.)
"By complying with international practices, it is easier for domestically based pharmaceutical companies to [perform] export activities, especially national firms that have been growing steadily," adds Alanac's Tada.
Other positive changes in the revised GMPs, according to specialists, are related to the global harmonization of procedures and the sharing of relevant information among international regulatory bodies. According to Anvisa, Brazil regularly collaborates with other regulatory and surveillance bodies with regard to information-sharing about inspections.
"Brazil, as a member of the Mercosur trade pact, participates actively in activities ... by sharing data and harmonizing procedures and rules," says Vogler. For example, Anvisa works regularly with the Pan American Network for Drug Regulatory Harmonization (PANDRH). The network was established in 1999 "to support processes on drug regulatory harmonization," according to the US Food and Drug Administration website. Participants in PANDRH include national authorities in the Americas, pharmaceutical interest groups, industry, and academia.
Although the Brazilian pharmaceutical industry does not participate in quality systems and analytical-testing activities as called for by the International Conference on Harmonization (ICH), notes Tada, Anvisa bases its technical guidelines on those of ICH.
Hellen Berger is a business writer based in São Paulo, Brazil.