In the development of MAP products it is important to exemplify features of the device that are critical to their safety and efficacy, i.e. their critical quality attributes (CQAs), using appropriate test methods. Validated and widely recognised standardised test methods have therefore been developed for established dosage forms e.g. in international Pharmacopoeia. These tests can be employed in both the pre-clinical development and quality assurance of pharmaceutical products. Whilst some of these test methods have been adopted to evaluate MAP products, the unique features of this new dosage form may require adaptations to these methods and/or the development of bespoke tests. The RWG has therefore prioritised MAP CQAs that would benefit most from an enhanced understanding of the application of existing established tests and/or the development of more bespoke methods.
These high priority CQAs, in rank order, are:
These high priority CQAs, in rank order, are:
1. Delivered dose
2. Puncture Performance
3. Dissolution
4. Physical Stability
5. Mechanical Strength
6. Needle Morphology
2. Puncture Performance
3. Dissolution
4. Physical Stability
5. Mechanical Strength
6. Needle Morphology
We are currently reviewing test methods that have been used to evaluate these CQAs and are working in the laboratory to explore the potential of new test methods for MAPs, with the aim of disseminating our findings to stakeholders to ensure mutual benefit. If you have experience validating and/or developing tests for MAP CQAs and would be willing to share your learnings then please contact us.
Page updated 15 September 2023
