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Forced Degradation (1) HPLC (8) ICH (10) Lifecycle (5) Method development (2) Methods (1) MTS (1) MTS Helpdesk (11) OOS/OOT (1) Procedures (1) Stability (3) Troubleshooting (1) Validation (15) Verification (1) Video (5) Webinar (2)
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MTS Course Calendar for 2024
The MTS course schedule for 2024 is now available For more information on any of our training courses, select from the course list. Contact us if you have any questions.
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Examples of Risk Assessment for Method Verification
EDQM has published a companion text to the general chapter 5.26, Implementation of pharmacopoeial procedures, which provides examples of risk assessments for the implementation process, applied to a variety of different types of analytical methods. The risk assessments are an excellent resource, not just for method verification but also for other lifecycle management activities, such…
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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…
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JPAG Symposium: Stability VI
The MTS consultant, Oona McPolin, will deliver a presentation entitled, ‘Challenges in Development and Validation of Stability Indicating Methodology‘ at the JPAG symposium, ‘Stability VI’ on the 30th June 2022, which will be held at the Royal Society of Chemistry in Burlington House, London. If you are interested in the analytical methodology used for supporting…
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Limit of Quantitation: Does it Matter?
MTS Helpdesk Question: Is the limit of quanitation always important when validating methods for impurities? Answer: Defined as “the lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy” in ICH Q2, limit of quantitation (or ‘quantitation limit’ in the ICH terminology) is an important method performance characteristic…
Forced Degradation (1) HPLC (8) ICH (10) Lifecycle (5) Method development (2) Methods (1) MTS (1) MTS Helpdesk (11) OOS/OOT (1) Procedures (1) Stability (3) Troubleshooting (1) Validation (15) Verification (1) Video (5) Webinar (2)