Tag: ICH

ICH Updates in Our Validation Courses

Draft versions of the revision of ICH Q2, Validation of Analytical Procedures, and also the new guideline Q14, Analytical Procedure Development, were published on the 24th March 2022. We have modified our courses, ‘Validation, Verification & Transfer of Methods for Pharmaceutical Analysis,’ and, ‘Validation, Verification & Transfer of Methods for Biopharmaceutical Analysis‘, to ensure that […]

Limit of Quantitation: Does it Matter?

Defined as “the  lowest amount of analyte  in a  sample which  can be quantitatively determined with  suitable precision and  accuracy” in ICH Q2(R1), limit of quantitation (or ‘quantitation limit’ in the ICH terminology) is an important method performance characteristic which is typically demonstrated during analytical method validation. Although the concept of limit of quantitation (LOQ) […]

Drafts of ICH Q2(R2) and Q14 on Public Consultation

Draft versions of the revision of ICH Q2, Validation of Analytical Procedures, and also the new guideline Q14, Analytical Procedure Development, were published on the 24th March 2022. The deadline for comments is 31st July 2022. You can view the draft guidelines, and also a presentation from ICH about the guidelines, using the following links: […]

What is Mass Balance in a Forced Degradation Study?

Question: What is the ‘mass balance’ for an analytical method and is it critical that I investigate it as part of method development or method validation? Answer: When used in the context of an analytical method, the term ‘mass balance’ relates to its ability to analyse the degradation products of a drug molecule. A method […]

Where do the Acceptance Criteria in Method Validation Come From?

Webinar Recording One of the most difficult tasks when writing an analytical method validation protocol is to set suitable acceptance criteria, particularly for the characteristics of accuracy and precision. It sometimes seems that the values are just plucked out of the air! Available guidance documents, such as ICH Q2(R1), don’t mention any numbers. In this […]