Nelson Laboratories enlarges its list of Good Manufacturing Practice (GMP) certifications with the addition of Australia’s Therapeutic Goods Administration (TGA) certification for sterility testing on biologics. TGA certification represents that Nelson Labs has demonstrated lab management practices and systems compliant with Australian regulatory code. Device manufacturers manufacturing in, or supplying medical devices to Australia, can now rely on Nelson Labs to perform testing for this region.
SALT LAKE CITY, UT – January 4, 2016 – Nelson Laboratories is proud to announce that it has been inspected and approved by Australia’s Therapeutic Goods Administration (TGA). The governing body responsible for regulating therapeutic goods, including medical devices, in Australia, TGA is considered one of the strictest regulatory agencies in the world. TGA regulates medical devices imported to and manufactured in Australia.
TGA certification expands Nelson Labs’ already vast Good Manufacturing Practice (GMP), Food and Drug Administration (FDA), and International Standards Organization (ISO) certifications. Nelson Labs is certified to perform sterility testing, including bacteriostasis and fungistasis testing, on biologics (products made from human cells or tissue). Device manufacturers in Australia or servicing the Australian market can now rely on Nelson Labs to perform their medical device testing.
“We are focused on our customers and meeting their testing needs. In doing so, we realize that we must be able to provide global solutions,” said Jeffery R. Nelson, Nelson Laboratories President and CEO. “This year we’ve expanded our sales presence in Europe, Israel, and Turkey. Certification by Australia’s TGA is another example of our commitment to support our customers in both local and global locations to help those expanding their business into today’s worldwide marketplace.”
Similar to the European Union, TGA regulatory principals and requirements are based on the global harmonization approach developed by the Global Harmonization Task Force. Medical devices marketed and sold in Australia also undergo an approval regiment to be included in the Australian Register of Therapeutic Goods (ARTG).
The purpose of TGA’s inspection of Nelson Labs was to establish whether Nelson Labs’ management systems and practices comply with relevant Australian code, quality management system standards, and regulations. The audit was performed by examining actual practices, documentation and records, and comparing them against Nelson Labs’ policies and procedures and relevant Code or Quality Management System Standard requirements.
Visit www.nelsonlabs.com for more information about Nelson Labs’ medical device testing services.
About Nelson Laboratories: Established in 1985, Nelson Laboratories is a leading provider of testing and consulting services. We know that every test matters and requires solutions that improve patient outcomes. We call it The Science of Success®. It means working with clients to ensure the safety and efficacy of every product.