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Presentation: Compliance history as a driver for reinspection frequencies

TGA presentations: ARCS Scientific Congress Canberra, 10-11 August 2016

15 August 2016

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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.

Presentation

  • Presented by: Harry Rothenfluh PhD
  • Presented at: ARCS Scientific Congress
  • Presentation date: 10-11 August 2016
  • Presentation summary: This presentation provides an update of changes the TGA have made to the product / process risk matrix and reinspection frequencies for medicines and blood, tissue and cellular therapies.

Transcript

Compliance history as a driver for reinspection frequencies

Harry Rothenfluh PhD
Manufacturing Quality Branch, TGA

Slide 1 - 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

Slide 2 - Drivers for change

Slide 3 - TGA's purpose

Health Safety Regulation

To safeguard and enhance the health of the Australian community through the effective and timely regulation of therapeutic goods.

Slide 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."

Slide 5 - Understanding manufacturer compliance risk

Slide 6 - Understanding compliance attitudes

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

Slide 7 - Domestic inspection outcomes

line graph

Slide 8 - Overseas inspection outcomes

line graph

Slide 9 - Understanding intrinsic product/process risks

Slide 10 - Revised product/process risk matrix

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

Slide 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."

Slide 12 - Managing the risks - registered medicines and blood, tissues and cellular therapies

Risk rating Third and subsequent consecutive A1 Second consecutive A1 First A1 A2 A3
H 36 + reduced scope inspection 36 24 18 12
M 36 + reduced scope inspection 36 30 20 15
L 36 + reduced scope inspection 36 + reduced scope inspection 36 24 18

Slide 13 - Managing the risks - listed medicines

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

Slide 14 - Monitoring and ensuring compliance

"A full suite of regulatory tools is appropriately utilised to ensure compliance."

Slide 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

Slide 16 - Questions

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