MAP-RWG
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  • What is a MAP?
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    • Defining the Delivery System
    • Critical Quality Attributes (CQAs)
    • Test Methods for MAPs
    • Microbial Considerations
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Critical Quality Attributes (CQAs)

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 (summarised in this document) 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. This work directly informed a White Paper publication, which identifies MAP CQAs and considers those that are most pertinent to the dosage form. A detailed discussion related specifically to the microbiological considerations and associated risk assessment for MAP products can be found in a further publication.
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  • Biocompatibility
  • Delivered Dose
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  • Assay
  • Chemical Stability
  • Content Uniformity
  • Drug Release / Dissolution /  Disintegration
  • Drug Purity /  Impurities / Residual Solvents
  • Extractables / Leachables
  • Identity
  • Polymorphism
  • Water Content​
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  • Microbiological Specification including adventitious agents and endotoxins
  • Particulates
  • Water Activity​
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  • Adhesion
  • Container Closure System / Packaging
  • Mechanical Strength
  • "Needle" Morphology
  • Physical Stability
  • Puncture Performance
  • Wear Time
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Page updated 07 January 2025
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  • Home
  • What is a MAP?
  • Our Activities
    • Defining the Delivery System
    • Critical Quality Attributes (CQAs)
    • Test Methods for MAPs
    • Microbial Considerations
  • Dissemination
  • Collaborate
  • Register Your Interest
  • News and Events
  • Contact Us