A critical quality attribute (CQA) is 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." (ICH Q8(R2) Pharmaceutical Development). Whilst CQAs are product specific, some attributes will be applicable to all, or a majority, of products within a class. The Regulatory Working Group has been working on defining and describing CQAs that are relevant and pertinent to MAPs.

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A literature review and formal discussions with over 20 stakeholders was used to draft a list of MAP CQAs and related MAP specific considerations. Importantly, this exercise helped the RWG to identify those CQAs that have a particular relevance to the MAP delivery system and has informed current activities related to sterility requirements for MAPs and the standardised test methods that are needed to help exemplify MAP CQAs.

Bio-compatibility
Delivered Dose

Assay
Chemical Stability
Content Uniformity
Dissolution and / or Disintegration
Drug Purity / Impurities / Residual Solvents
Extractables / Leachables
Identity
Polymorphism
Water Content
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Microbiological Specification
Particulates
Water Activity
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Container CLosure System / Packaging
Mechanical Strength
"Needle" Morphology
Patch Adhesion
Physical Stability
Puncture Performance
Wear Time
​

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Page updated 15 September 2023