Hall Analytical are about to start some R&D activities relating to inter and intra batch variability. This work will be in the spirit of ICH Q10 and quality by design (QbD). The study aim is to better understand how extractable and leachable data varies with different batches of the same material. From this we aim to reduce the variability in the E&L profiles for the materials of a product, by looking at the parameters which affect material variability.
Hopefully, this information will help our customers draw better conclusions on variability to mitigate risk. In our study we will include:
- Inter batch variability i.e. start, middle and end of a manufacturing campaign and variability at a similar point of the manufacturing campaign.
- Multi batch variability using similar conditions
- Multi batch variability due to age
- Multi batch variability due to change in manufacturing parameters
We hope to share updates on our findings in the coming months. Watch this space!