Compliance history as a driver for reinspection frequencies Harry - PowerPoint PPT Presentation

Compliance history as a driver for reinspection frequencies Harry Rothenfluh PhD Manufacturing Quality Branch, TGA

Overview • This presentation provides an update of changes we have made to: • product / process risk matrix • reinspection frequencies for medicines and blood, tissue and cellular therapies 2

Drivers for change 3

TGA’s purpose To safeguard and enhance the health of the Australian Health community through the effective and timely regulation of Safety Regulation therapeutic goods. 4

Regulator performance framework KPI 3 - Actions undertaken by regulators are proportionate to the regulatory risk being managed “ Efficient regulatory risk assessment takes account of the regulated activity, the nature of the regulated cohort, including its compliance history , and other external factors affecting risk .” 5

Understanding manufacturer compliance risk 6

Understanding compliance attitudes Voluntary Accidental non- Opportunistic non- Intentional non- compliance compliance compliance compliance • Effective • Ineffective and/or •Resistance to •Deliberate non- compliance developing compliance compliance compliance systems systems •Limited or poor •No compliance • Management is • Management is compliance systems systems compliance compliance oriented but •Management not •Criminal intent oriented lacks capability compliance oriented Committed to Trying to do the right Don't want to comply Decision to not doing the right thing but don't always but will if made to comply thing succeed 7

Domestic inspection outcomes 8

Overseas inspection outcomes 9

Understanding intrinsic product/process risks 10

Revised product/process risk matrix Product/ Medical Product Description BTCT Product Description process Risk Sterile medicines, single step sterilisers, sterile APIs to be used Primary collection, processing and storage sites in aseptic conditions, biotechnology APIs for blood, including human haematopoietic stem High cells (HPCs), tissue banks and complex processing, cellular therapies. Other sterile APIs used with terminal sterilisation step, Secondary blood collection and separation sites registered non-sterile medicines (including registered herbal (including apheresis), tissues banks with low Medium medicines), manipulation Non-sterile APIs for registered medicines ,all listed medicines Other (not primary or secondary) blood (including listed herbal medicines), sunscreens, medicinal gases, collection sites, including mobile units Low single step – labelling/packaging; release for supply, storage All remaining non-sterile APIs, Other N/A homoeopathic products, 11

Managing manufacturing quality risks “ Where the risk of non-compliance is high or the consequence of non- compliance significant, there is a higher degree of monitoring .” 12

Managing the risks – registered medicines and blood, tissues and cellular therapies Risk Third and subsequent Second consecutive A1 First A1 A2 A3 rating consecutive A1 H 36 + reduced scope 36 24 18 12 inspection M 36 + reduced scope 36 30 20 15 inspection L 36 + reduced scope 36 + reduced scope 36 24 18 inspection inspection 13

Managing the risks – listed medicines Risk Third and subsequent Second consecutive A1 First A1 A2 A3 rating consecutive A1 L 48 + reduced scope 48 42 30 18 inspection Other • Reinspection only if risk information or complaint • Biennial compliance review (desk top) 14

Monitoring and ensuring compliance “A full suite of regulatory tools is appropriately utilised to ensure compliance.” 15

Monitoring and compliance tools • Collaboration with international regulators • Manufacturing quality signal detection • Unannounced inspections • Bring planned inspections forward • Condition, cancel, suspend GMP licence • Cancel GMP clearances 16

Questions 17