| 00:00:00 | Untitled |
| 00:00:59 | Application of QbD to analytical method development for particle size distribution measurements |
| 00:01:51 | What is Quality by Design? |
| 00:02:53 | Applying QbD involves developing a full understanding of a product and its performance |
| 00:05:00 | Applying QbD for AM involves developing a full understanding of a method and its performance |
| 00:07:46 | Stage 1: Analytical Target ProfileDetermining the goals of an analytical method |
| 00:08:15 | The first stage in developing a method is to understand why the measurement is being made |
| 00:09:10 | Untitled |
| 00:11:19 | Once we know why we are making a measurement, we can define the Analytical Target Profile |
| 00:12:47 | Stage 2: Identify Critical Method AttributesDeveloping a target method for product analysis |
| 00:13:12 | For particle size measurements, the processes of sampling and dispersion must be controlled |
| 00:14:18 | Sampling control ensures that the analysed sample is representative of the bulk material |
| 00:15:21 | Dispersion control ensures we measure the sample in a relevant, reproducible way |
| 00:16:37 | Dispersing particles in liquids requires the following steps to be followed |
| 00:18:33 | Dispersing particles as dry powders requires the following steps to be followed |
| 00:20:22 | Stage3: Risk Assessment |
| 00:21:03 | Guidance is available to help determine if a particle sizing method is realistic |
| 00:23:30 | Risk Assessment for liquid dispersion methods |
| 00:27:21 | Liquid dispersion: sonication power and time |
| 00:30:42 | Liquid dispersion: sample concentration |
| 00:32:19 | Liquid dispersion: stir speed |
| 00:33:16 | Liquid dispersion: measurement time |
| 00:34:29 | Risk Assessment for dry dispersion methods |
| 00:36:01 | Dry dispersion: crystalline powder measured using a high energy disperser |
| 00:37:31 | Dry dispersion: crystalline powder measured using a lower energy disperser |
| 00:38:13 | Dry dispersion: feed rate / concentration |
| 00:39:34 | Dry dispersion: sample quality and measurement duration |
| 00:40:49 | Risk assessment: worked example for a wet laser diffraction method using external sonication |
| 00:42:30 | SOP playlist functions allow automated robustness studies to be carried out |
| 00:43:22 | Step 4: ControlMethod validation for particle size measurements |
| 00:43:34 | How should a particle sizing method be validated? |
| 00:44:34 | Instrument SOPs provide a means of controlling all critical quality attributes for methods |
| 00:45:17 | Assess the measurement precision using one operator |
| 00:46:19 | Change operator to assess the intermediate precision |
| 00:46:47 | Calculate the intermediate precision by pooling all of the results |
| 00:47:49 | Modern particle sizing system offer tools to continuously monitor data quality |
| 00:48:57 | Review tools are also available to help with checking that methods are used correctly |
| 00:49:39 | What are the benefits of applying QbD for analytical method development? |
| 00:51:28 | References |
| 00:51:58 | Application of QbD to analytical method development for particle size distribution measurements |
| 00:52:05 | Questions? |
| 01:11:29 | Contact Information |
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.