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TGA presentation: given at the Parenteral Drug Association end of year event, 29 November 2016

Presentation: This year's highlights and what's ahead for 2017

6 December 2016


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  • Presented by: Jenny Hantzinikolas, Director, Inspections Section, Manufacturing Quality Branch, Therapeutic Goods Administration
  • Presented at : Parenteral Drug Association end of year event
  • Presentation date: 29 November 2016
  • Presentation summary: This presentation provides an update on the new close out process for inspections, the new risk matrix and reinspection frequencies, as well as plans for the Inspections Section for 2017.


This year's highlights and what's ahead for 2017

Jenny Hantzinikolas
Director, Inspections, Manufacturing Quality Branch Medical Devices and Product Quality Division, TGA

Parenteral Drug Association end of year event, 29 November 2016

Slide 1 - Overview

  • Close out process
  • Product/process risk matrix changes
  • Reinspection frequencies changes
  • Common deficiencies from sterile manufacture inspections for 2015 and 2016 (to date)
  • What's ahead

Slide 2 - Close out process

There is a new close out process

  • Issue post inspection letter
  • Responses received on a close out template
  • Objective evidence requested only under certain situations, e.g. initial, recurring issues

Slide 3 - Close out process

  • Final inspection report written once the inspection is closed out
  • Addition of time at the next inspection for A2 and A3 manufacturers to review the evidence from the CAPA Plan

Slide 4 - Risk Based Inspection

We have made changes to:

  • product / process risk matrix
  • reinspection frequencies

for medicines and blood, tissue and cellular therapies

Slide 5 - Drivers for change

Slide 6 - 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 7 - 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 8 - Understanding manufacturer compliance risk

Slide 9 - 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 10 - Domestic inspection outcomes


Slide 11 - Overseas inspection outcomes


Slide 12 - Understanding intrinsic product/process risks

Slide 13 - 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 14 - 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 15 - Managing the risks - registered medicines, API's 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



M 36 + reduced scope inspection 36 30 20 15
L 36 + reduced scope inspection 36 + reduced scope inspection 36



Slide 16 - 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



  • Reinspection only if risk information or complaint
  • Biennial compliance review (desk top)

Slide 17 - Monitoring and ensuring compliance

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

Slide 18 - 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 19 - Portfolio Budget Statement

16/17 Financial Year


Slide 20 - Common deficiencies

2015 – Domestic manufacturers
Poor Investigations Quality risk management
Inadequate procedures Environmental monitoring
Automated systems GMP contracts
Poor records Microbial contamination
Validation Training

Slide 21 - Common deficiencies

2015 – Overseas manufacturers
Poor Investigations Testing
Inadequate procedures Labelling
Storage Document control
Validation Potential for cross contamination
Automated systems Training

Slide 22 - Common deficiencies

2016 – Domestic manufacturers (trends up to August 2016)
Poor procedures Quality Risk management
Microbial contamination Environmental monitoring
Automated systems Potential for cross contamination
Poor records Training
Validation Cleaning

Slide 23 - Common deficiencies

2016– Overseas manufacturers (trends up to August 2016)
Poor procedures Quality risk management
Inadequate Investigations Environmental monitoring
Automated systems Change control
Poor records Microbial contamination
Validation Training

Slide 24 - What's ahead

  • The adoption of the latest PIC/S revision
  • Continued work with PIC/S
  • Greater awareness of Data Integrity areas (not new)
  • Revision of the GMP guidelines for overseas manufacturers
  • Embedding the new risk based inspection processes

Slide 25 - Questions

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