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This co-publication between USP and Alphalyse has a very good comparison of LC-MS approaches and performance on ICH Q2 guidelines on e.g. accuracy and...

No qualification or validation is required for analytical characterization methods. Having said that, regulatory agencies do expect that analytical ch...

No validation is required for characterization. However, you should demonstrate that the analytical method is measuring what it is supposed to do. E.g...

EMA reviewers are recommending a science-driven risk-based HCP control strategy using best practice methods, including USP chapters 1132, 1132.1, with...

I have no experiences with viral vaccines, but generally speaking, acceptance limits evolve throughout development, as more information about batch, p...

Alphalyse is analysing many viral vector based products, including Vero cells and many exotic cell lines used in vaccines. The acceptance limits are d...

Yes, this is a typical problem for qualification of HCP ELISA. Lack of dilutional linearity is often due to high responder HCPs. And when you have to ...

Although I am not aware of a ‘definitive database of common HCPs’, ample scientific reports have been published over the past decade about what (CHO) ...

I have no experience with CAR and ELISA assay forced degradation. Available guidance, such as the Brazilian ANVISA, Guideline No. 04/2015 focus on che...

I do not have specific information, but I have heared that Pfizer and GSK filed MODRs.   Join Dr. Joachim Ermer (Ermer Quality Consulting) to...

Yes, that's perfectly true. The initial validation should be regarded as a starting point, i.e. the formal approval of the analytical procedure for pr...

The guideline does not go into details. Of course, you have to take the samples and ranges available or accessible. Whether or not to extrapolate by c...

In principle, this is a prediction interval, but it's referred in the statistical literature as beta-expectation tolerance intervals, in opposition to...

CI are required for validation submission. Once you can compute them, there is no reason to not always report them, even if only for information. The ...

I would always make a risk assessment and identify the method type (impurity, quantitative, etc.) to ensure the relevant parameters are computed. &n...