TGA - SME Assist ‘Navigating therapeutic goods regulation‘
SME Assist
5 episodes
9 months ago
Helping small to medium enterprises, researchers, start-ups and anyone new or unfamiliar with regulation to understand their obligations when it comes to supplying therapeutic goods in Australia.
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Helping small to medium enterprises, researchers, start-ups and anyone new or unfamiliar with regulation to understand their obligations when it comes to supplying therapeutic goods in Australia.
Australian manufacturing licences and GMP for medicines and biologicals
TGA - SME Assist ‘Navigating therapeutic goods regulation‘
18 minutes
4 years ago
Australian manufacturing licences and GMP for medicines and biologicals
Join us for this episode as we speak with Nadia Saleh, Inspector in the Manufacturing Quality Branch at TGA and discuss:
what role TGA plays in ensuring quality manufacturing practices and why this is important
what Good Manufacturing Practice (GMP) is
how this applies to manufacturers of medicines and biologicals
the inspection process
how COVID-19 has affected the way we work
We also learn about some of the innovative ways TGA is working with manufacturers of medicines and biologicals including some of the technology being used for remote inspections.
This podcast series is presented by the SME Assist team at TGA. SME Assist is a dedicated service that TGA offers to help small to medium enterprises (SMEs), researchers, start-ups and those unfamiliar with regulation to understand their regulatory and legislative obligations.
You can find more information about TGA and SME Assist at www.tga.gov.au/sme-assist and through our social media channels or contacting us directly.
Phone: 1800 020 653
Email: sme.assist@tga.gov.au
Social Media: https://www.tga.gov.au/social-media
TGA BLOG: https://www.tga.gov.au/blogs/tga-topics
Links and useful information
TGA website tga.gov.au
Manufacturing therapeutic goods https://www.tga.gov.au/manufacturing-therapeutic-goods
Manufacturing inspections https://www.tga.gov.au/manufacturing-inspections
Manufacturing basics https://www.tga.gov.au/manufacturing-basics
Good manufacturing practice - an overview https://www.tga.gov.au/good-manufacturing-practice-overview
What type of GMP application do I require? https://www.tga.gov.au/good-manufacturing-practice-application-decision-tree
Host: Steven Smith-Fleury
Guest: Nadia Saleh
TGA - SME Assist ‘Navigating therapeutic goods regulation‘
Helping small to medium enterprises, researchers, start-ups and anyone new or unfamiliar with regulation to understand their obligations when it comes to supplying therapeutic goods in Australia.