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Millmount Healthcare, the award-winning Irish owned organisation specialising in blister and bottle/tub contract packaging, announces it has recently been audited and approved by the Regulatory Body of the Brazilian Government, ANVISA
Anvisa is responsible for the approval and supervision of pharmaceuticals, food, cosmetics, tobacco, health services and medical devices that enter the Brazilian Market.
Two inspectors from ANVISA were scheduled to perform a general GMP inspection from November 7th to 11th on our City North site. Due to the auditors’ confidence in Millmount Healthcare, this was reduced to 3 days. Both auditors were very impressed with our facility and the calibre of people they interacted with and remarked that the Millmount Healthcare Quality Systems were in line with their expectations from Big Pharma. We received no citations during the course of the audit.
This very successful audit is a big step in Millmount’s journey and proves that our packaging services and Quality systems are acceptable for Brazilian standards. In addition to our FDA, HPRA, GMP, Veterinary and IMP licences, this proves to be a very welcome extension to our portfolio being in a better position to serve diverse markets.
Alan Longworth, Millmount Healthcare’s Head of Quality also comments, “The success of this audit proves that the Process and Quality Systems at Millmount Healthcare meet the required standards and are robust as the company grows. This is an excellent platform for Millmount Healthcare to enter the Brazilian market and perform the companies cutting edge services to the highest of standards”