CRITICAL QUALITY

ATRIBUTES (CQA)

DAIPADLI
NUR AINI FADILAH
ROSIATI
Critical Quality Attributes (CQA)

“A physical, chemical, biological or microbiological

property or characteristic that should be within an
appropriate limit, range, or distribution to ensure the
desired product quality”.

Identify
the
CQAs

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Could be for Raw Materials, Excipients, Drug
Substance, intermediate, container closure components.
Developed from extensive product development
& understanding
May only have limited information at early
Stage1, so first set of
CQA’s may be based on prior knowledge &
experience
Decisions on criticality should be identified using a
scientific evidence and a risk-based approach.
Identify items that impact Safety, Quality, Identity, Potency,
Purity (SQuIPP).
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 Critical Quality Attribute

Drug Substance Drug product

(chemical) (tablet)
Appearance Appearance
Particle size Identification
Morphic forms Hardness Risk in
1. Continuity of
Water content Uniformity of dosage Quality
Residual solvents Physical form attribute
Organic impurities 2.
Dissolution Continuity of
Inorganic impurities
Impurities Supply
Heavy metals Degradation 3. Reasonable in
Residue on ignition products cost
Assay Water
content
Assay
Microbiolo
gical limits
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1. Attributes not defined as critical could still be monitored
during the Development phase.
2. CQAs are subject to change as product and process
knowledge develops (Design of Experiment and Design
Space)
3. Continue using Quality Risk Management
4. CQAs are usually linked to test specifications
5. All CQAs should be fully understood and defined before
moving to stage 2

Input Process Output

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