CONFIDENTIAL 1

ISO 20069Assessment & Evaluation of Changes to Drug Delivery Systems

Paul Jansen, PEChair Elect ISO TC84Board Member & Senior Advisor, HaselmeierBoard Member, Subcuject

CONFIDENTIAL 2

Drug Delivery Combination (DDC) products require assessment & evaluation when drug and device changes are proposed.

There is significant variability as to how companies manage those changes.

It is proposed to adopt a common framework for assessing & evaluating changes.

The framework of an ISO standard will be based upon a risk based approach.

CONFIDENTIAL

ISO 20069 is Here

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CONFIDENTIAL

2010 IPAC-RS/ISAM workshop Frankfurt

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http://ipacrs.org/assets/uploads/outputs/Track_D.pdf

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CONFIDENTIAL 6

Significant variability as to how companies manage changesRisk Management does not appear to be informing decision making.

Formulation & viscosity changes

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Colour change

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Process changes• Manual to automatic• Glue to sonic welding

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Single Cavity mold to Multiple Cavity

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User interface change

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Assess & Evaluate impact:

Changes related to:

Medicinal productcomponent Device component

Medicinal productcomponent

x

Out of scope

In scope

Device component In scope

In scope

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-

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Drug changes impacting device vs Device changes impacting drug

……….. It is the responsibility of organizations to provide evidence that the approach adopted is commensurate with the level of risk so as to ensure the quality, safety and effectiveness of the drug delivery system. While the focus of this document is change to the drug delivery system, it is also possible that changes to the medicinal product might impact the drug delivery system (e.g. change in viscosity or volume of medicinal product resulting in changed drug delivery system performance. It is also possible that changes to the drug delivery system might impact the medicinal product (e.g., increased injection forces resulting in changed medicinal product quality). …………

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- To be clear and concise

- To be descriptive not descriptive

- Global

- Gain good regulatory inputs

- Achieve consensus (always an ISO challenge!)

- Align with other documents – ie. ICH Q12

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CONFIDENTIAL 16

ISO 20069 & ICH Q12 Alignment

ISO 20069

What and how Device assessment & evaluation - not drug/biologic Risk based assessment Focus on using prior knowledge Does not provide scope as it relates to a regulatory

submission

ICH Q12

Provides guidance on what to submit (or if to submit)

ICH Q12 complements ISO 20069

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- Issue Draft International Standard (DIS) – June 2018

- Public Enquiry – June to September 2018

- ISO WG15 Committee Meeting – October 2018

- Issue Final Draft International Standard (FDIS) - 2019

Paul Jansen, PEISO TC 84 Chair Elect

Board Member & Senior Advisor, Haselmeier

paulejansen@gmail.com+1 857 203 1470

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