Date recorded: September 06 2018

Duration: 46 minutes 36 seconds

The Quality by Design (QbD) principles outlined by Jurong have found a natural home in the arena of pharmaceutical method development. This presentation will outline what QbD is, how it works within pharmaceutical development, and will provide some examples of the 'fishbone' diagrams which show the factors that should be considered when developing methods for laser diffraction and dynamic light scattering.
Table of contents
1. The principles of setting up robust particle characterization methods using a Quality by Design approach
01:26
2. Intro
00:00
3. The principles of setting up robust particle characterization methods using a Quality by Design approach
01:37
4. Intro
00:00
5. What is Quality by Design?
00:46
6. Applying QbD involves developing a full understanding of a product and its performance
01:41
7. Applying QbD for analytical methodologies involves developing a full understanding of a method and its performance
00:11
8. Stage 1: Analytical Target ProfileDetermining the goals of an analytical method
00:07
9. The first stage in developing a method is to understand why the measurement is being made
01:36
10. Untitled
00:40
11. Once we know why we are making a measurement, we can define the Analytical Target Profile
00:15
12. Stage 2: Identify Critical Method AttributesDeveloping a target method for product analysis
00:06
13. For particle size measurements, sampling and dispersion must be controlled
01:46
14. Sampling control ensures that the analyzed sample is representative of the bulk material
01:06
15. Dispersion control ensures we measure the sample in a relevant, reproducible way
01:35
16. Dispersing particles in liquids requires these steps to be followed:
01:20
17. Dispersing particles in liquids requires these steps to be followed:
01:21
18. Dispersing particles in liquids requires these steps to be followed:
00:44
19. Dispersing particles as dry powders requires these steps to be followed:
01:24
20. Stage 3: Risk AssessmentDefining the Method Operable Design Region
00:08
21. Guidance is available to help determine if a particle sizing method is fit for purpose
01:24
22. Risk Assessment for liquid dispersion methods
01:53
23. Liquid dispersion: sonication power and time
00:24
24. Liquid dispersion: sample concentration
01:16
25. Liquid dispersion: stir speed
00:42
26. Liquid dispersion: stir speed
00:28
27. Liquid dispersion: measurement time
00:36
28. Risk Assessment for dry dispersion methods
02:13
29. Dry dispersion: crystalline powder measured using a high energy disperser
00:21
30. Dry dispersion: crystalline powder measured using a lower energy disperser
01:09
31. Dry dispersion: feed rate / concentration
00:40
32. Dry dispersion: sample quality and measurement duration
00:29
33. Risk assessment: worked example for a wet laser diffraction method using external sonication
00:53
34. Not just for laser diffraction!Applies to any technique or any problem
03:29
35. Step 4: ControlMethod validation for particle size measurements
00:06
36. How should a particle sizing method be validated?
00:24
37. Instrument SOPs provide a means of controlling all critical quality attributes for methods
00:13
38. Assess the measurement precision using one operator
00:32
39. Change operator to assess the intermediate precision
00:23
40. Calculate the intermediate precision by pooling all of the results
00:31
41. What are the benefits of applying QbD for analytical method development?
01:36
42. References
00:16
43. Question & Answer SessionListening on demand?email your questions to:events@malvernpanalytical.comThank you for attending
08:49