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.
Bio-compatibility
Delivered Dose |
Assay
Chemical Stability Content Uniformity Dissolution and / or Disintegration Drug Purity / Impurities / Residual Solvents Extractables / Leachables Identity Polymorphism Water Content |
Microbiological Specification
Particulates Water Activity |
Container CLosure System / Packaging
Mechanical Strength "Needle" Morphology Patch Adhesion Physical Stability Puncture Performance Wear Time |
Page updated 15 September 2023
