Presentations given by the TGA at the Good Manufacturing Practice (GMP) Forum 2021, Online, 12-14 May 2021
Presentations
- Regulation in times of a pandemic
- GMP inspection trends for non-sterile registered medicines
- Overview of GMP regulatory activities
- Inspection reliance
- Remote GMP inspections: Current feedback and future considerations
- Clean room requirements for biologicals
- Code tables for GMP clearances
- GMP overview and an update on PIC/S guide to GMP for medicinal products version 14
- How to improve your GMP compliance for listed medicines and GMP implementation of TGOs 92 and 101
- Dispelling GMP myths of human blood, blood components, tissues, cells and gene therapies
- GMP licence applications
- GMP clearance - Common deficiencies
- Sterile medicines - lessons from StrugglePharm
- Manufacturing investigational medicinal products
- Management of GMP compliance signals
Disclaimer
These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.