PHOTO: JEREMY WOODHOUSE, DIGITAL VISION, GETTY IMAGES
|
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.)
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."
Quality assurance
"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Then, in 1961, the sedative Thalidomide was withdrawn after it was discovered to cause birth defects in children whose mothers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.
