CRED Getting the CMC Dossier Right 2024

05/09/2024

ICH Q8 - Quality Target Product Profile Considerations

• The clinical condition

• Acute or chronic, duration of action, site of action etc.

• The “user” (patient, care -giver and healthcare professionals)

• Age, health, cultural factors • Reflection paper on products for older patients (EMA/CHMP/QWP/292439/2017) • Paediatric investigation plans (PIP) • Existing therapy

• What is the advantage of the new drug?

• Can you demonstrate superior efficacy or safety?

• Easier administration?

The Organisation for Professionals in Regulatory Affairs

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QTPP – example entries

Product Attribute

Target

Acceptance criteria

Dosage form

Tablet, Capsule, Oral solution

Route of administration

Oral, intravenous

Description

Strength

Unit dosage form, mg, mg/mL

Assay

Meets pharmacopoeia requirements

95.0-105.0%

Degradation products

Meets ICH Q3B

Specified Unspecified Total

Microbiological limits

Meets pharmacopoeia requirements

Limits

Shelf life

Minimum x months, ICH Q1

Meets at end of shelf life

The Organisation for Professionals in Regulatory Affairs

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