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