記録された日時: February 06 2014

Duration: 01 hours 13 minutes 20 seconds

The last decade has seen a shift within the pharmaceutical industry towards Quality by Design - a risk-based approach to the development and manufacture of pharmaceutical products. This adoption of QbD has led to it being applied to analytical method development, where the process of identifying critical method parameters and understanding a method's design space provides significant benefits to users in developing appropriate, robust measurement procedures. In this webinar we introduce how QbD can be applied in the case of particle size analysis, considering the requirements for both liquid and dry powder dispersion.
Table of contents
1. Untitled
00:59
2. Application of QbD to analytical method development for particle size distribution measurements
00:52
3. What is Quality by Design?
01:02
4. Applying QbD involves developing a full understanding of a product and its performance
02:07
5. Applying QbD for AM involves developing a full understanding of a method and its performance
02:46
6. Stage 1: Analytical Target ProfileDetermining the goals of an analytical method
00:29
7. The first stage in developing a method is to understand why the measurement is being made
00:55
8. Untitled
02:09
9. Once we know why we are making a measurement, we can define the Analytical Target Profile
01:28
10. Stage 2: Identify Critical Method AttributesDeveloping a target method for product analysis
00:25
11. For particle size measurements, the processes of sampling and dispersion must be controlled
01:06
12. Sampling control ensures that the analysed sample is representative of the bulk material
01:03
13. Dispersion control ensures we measure the sample in a relevant, reproducible way
01:16
14. Dispersing particles in liquids requires the following steps to be followed
01:56
15. Dispersing particles as dry powders requires the following steps to be followed
01:49
16. Stage3: Risk Assessment
00:41
17. Guidance is available to help determine if a particle sizing method is realistic
02:27
18. Risk Assessment for liquid dispersion methods
03:51
19. Liquid dispersion: sonication power and time
03:21
20. Liquid dispersion: sample concentration
01:37
21. Liquid dispersion: stir speed
00:57
22. Liquid dispersion: measurement time
01:13
23. Risk Assessment for dry dispersion methods
01:32
24. Dry dispersion: crystalline powder measured using a high energy disperser
01:30
25. Dry dispersion: crystalline powder measured using a lower energy disperser
00:42
26. Dry dispersion: feed rate / concentration
01:21
27. Dry dispersion: sample quality and measurement duration
01:15
28. Risk assessment: worked example for a wet laser diffraction method using external sonication
01:41
29. SOP playlist functions allow automated robustness studies to be carried out
00:52
30. Step 4: ControlMethod validation for particle size measurements
00:12
31. How should a particle sizing method be validated?
01:00
32. Instrument SOPs provide a means of controlling all critical quality attributes for methods
00:43
33. Assess the measurement precision using one operator
01:02
34. Change operator to assess the intermediate precision
00:28
35. Calculate the intermediate precision by pooling all of the results
01:02
36. Modern particle sizing system offer tools to continuously monitor data quality
01:08
37. Review tools are also available to help with checking that methods are used correctly
00:42
38. What are the benefits of applying QbD for analytical method development?
01:49
39. References
00:30
40. Application of QbD to analytical method development for particle size distribution measurements
00:07
41. Questions?
19:24
42. Contact Information
01:51