Analytical Quality by Design (AQbD) principles to pharmacopoeial standards for medicines
This consultation asks for views on the application of AQbD principles to pharmacopoeial standards for medicinal products.
The guidance is found HERE
The Technical Review of MHRA Analytical Quality by Design Project is found HERE
Please send us your feedback comments by Monday 26 August 2019.
QUESTIONS BEING ASKED:
1. What do you see as the greatest opportunities and challenges affecting the quality of medicines in the next 5 years?
2. How can AQbD concepts ensure methods are fit for purpose and how can they enable innovation? How are AQbD concepts utilised within your organisation?
3. Please rank examples 1-5 in order of preference for presentation in the pharmacopoeia (1 is best). What advantages and disadvantages do you see in presenting AQbD information in the different examples?
4. What other options for the application of AQbD concepts to pharmacopoeial standards and presentation of the resulting information in the pharmacopoeia should we consider?
5. How can we work with you and your organisation to further develop our thinking on the application of AQbD concepts to pharmacopoeial standards?
6. Do you have any other comments regarding the application of AQbD concepts to pharmacopoeial standards?
Feel free to add your responses to a Word doc and email to email@example.com