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.
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.
“Needle” Morphology
Mechanical Strength Puncture Performance Patch Adhesion Wear time Container Closure System Packaging |
Microbial Limits/Sterility
Particulates |
Bio-compatibility
Delivered dose |
Identity
Assay Polymorphism Dissolution Disintegration Content Uniformity Residual Solvents Water Content Drug Purity Impurities Chemical Stability Extractables/Leachables |
What do you think?
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Click here to provide your thoughts on MAP CQAs and accompanying standardised test methods
