GMP Forum 2023

On 21 March 2023 GMP Forum returned to Sydney to provide industry stakeholders with a unique opportunity to connect with and learn from regulators and subject matter experts from across the TGA.

Main Room sessions

• Session 1 - Welcome and opening remarks (pdf,829kb)
• Session 2 - Forward vision: regulation and manufacture supply (pdf,796kb)
• Session 3 - Remote inspections: the past, present and future (pdf,676kb)
• Session 4 - Common inspection deficiencies and trends (pdf,822kb)
• Session 5 - Australian Sponsors and GMP (pdf,1630kb)
• Session 6 - PIC/S Annex 1 (pdf,2815kb)
• Session 7 - Adoption of future PIC/S revisions (pdf,1128kb)

Break-out Room sessions

• Session 1 - Data integrity and related laboratory deficiencies (pdf,1479kb)
• Session 2 - GMP for listed medicines (pdf,2142kb)
• Session 3 - Medicinal Cannabis: Complying with TGO 93 (pdf,1230kb)
• Session 4 - Medicine Shortages Strategies to mitigate supply chain disruptions (pdf,1262kb)
• Session 5 - GMP for Advanced Therapeutic Medicinal Products (ATMP) (pdf,1898kb)

Workshop sessions

• Session 1 - Medicinal Cannabis: Meeting your GMP responsibilities (pdf,640kb)
• Session 2 - Performing detailed investigations (pdf,597kb)
• Session 3 - GMP compliance signals: sponsors actions (pdf,542kb)