chris bravery presentation

8/22/2019 Chris Bravery Presentation

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[email protected]

Quality and Release Criteria:

A[n ex-]Regulators Perspective

Christopher A Bravery

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Importance of characterisation Physicochemical Biological

Specifications Basic expectations Dealing with limitations

Final thoughts

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Introduction


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Common Technical Document (CTD)


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Physicochemical Characterization

Product

Specification

Biological Characterisation

[Assumed] Mechanism of Action

Non-clinical

models Clinical data Literature

Working Theory

Identify possible biological characteristics

Select

tests

Identifypossiblerelevantphysicochemical

characteristics

ITERATIVE PROCESS

Characterisation


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Specifications: Product

Generally based on

same approach


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Process Characterisation


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Methods

See ICH Q2


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Dont Forget Reference Materials


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Using the results: Specifications

ProductKnowledge

Literature

Stabilitydata

Non-clinicaldata

Clinical

data

Characterisation

data

Product

Starting/rawmaterials

Process

Manufacturing

experienceStability

Product

knowledgeSpecification

Whats been

achievedlimitations

Safety

considerationsJustification


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Physicochemical Characterization Stability Studies

Product

Specification

Final Product

shelf-life, shipping

validation, in-use

stability.

Product Stability

Specification

Comparability

Comparability

Protocol

Product

Specification

In-process

controls

stability

indicating

Identity, purity,

impurities, other.

Key

physicochemical

characteristics

In vitro test/s and

assay/sSelect

tests

Biological Characterisation

Relevant

biological

function/s

Potency assay/s

In vitro bioassay/s

In vivo bioassay/s

Select

test/s

[Assumed] Mechanism of Action

Non-clinical

modelsClinical data Literature

Working Theory

Identify possible biological characteristics

Select

tests

Extended

Characterisation

Additional

useful

tests

Compatibility

Studies

Final Product

container, delivery

system, other

device

Product

compatibility

Product Stability

Specification

Potency: A Key Specification


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The Importance of Characterisation

11http://www.advbiols.com/documents/ImportanceofCharacterisation.swf


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Comparability Overview


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Extended Characterisation


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14 http://www.advbiols.com/documents/ICH.swf

ICH guidelines (core principles)


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15 http://www.advbiols.com/documents/EUguidelines.swf

EMA guidelines


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http://www.advbiols.com/documents/PhEur.swf

European Pharmacopoeia


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Specifications are set to control and confirm the qualityof the product for a specific qualified/validated process. Specifications are set based on manufacturing

experience and all other relevant information.

Change the process and the specification may no longerbe adequate to confirm or control quality.

Comparability may need enhanced testing to confirmthe product didnt change (specifications only valid for

the qualified/validated process) and to confirm the

specifications are still valid, or how they need to

change.

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Final Thoughts

chris bravery presentation

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