Blog
Forced Degradation (1) HPLC (8) ICH (17) Lifecycle (11) Method development (3) Methods (1) MHRA (1) MTS (7) MTS Helpdesk (14) OOS/OOT (2) Procedures (1) Stability (3) Troubleshooting (1) Validation (19) Verification (1) Video (4) Webinar (2)
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Why not Retest in Phase 1 OOS Investigation?
MTS HELPDESK: Why does the guidance from MHRA regarding investigation of out of specification (OOS) results not allow retesting in phase 1?
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JPAG Symposium: Analytical Method Technology Transfers
The MTS consultant, Oona McPolin, will be presenting at the upcoming JPAG symposium at the RSC in London on the topic of analytical method transfer.
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New dates in 2026 for the course, ‘What’s New in ICH Q2(R2) and Q14?’
We have added two new dates in 2026 for our course, ‘What’s New in ICH Q2(R2) and Q14?’ in September and November. On this course you will learn about the recent changes to the ICH guidance, Q2(R2), ‘Validation of Analytical Procedures’, and about the new guidance Q14, ‘Analytical Procedure Development’.
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What is Analytical Method Validation?
MTS HELPDESK: In ICH Q2(R2), the guideline about validation of analytical procedures that is used in the pharmaceutical/biopharma industry, it states that: ‘The objective of validation of an analytical procedure is to demonstrate that the analytical procedure is suitable for the intended purpose.’ Therefore, the aim of a validation study is to generate evidence which…
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When do I Need to Follow ICH Q2(R2) & Q14?
MTS HELPDESK: When do I have to start following the updated ICH guideline, Q2(R2) and the new guideline, Q14?
Forced Degradation (1) HPLC (8) ICH (17) Lifecycle (11) Method development (3) Methods (1) MHRA (1) MTS (7) MTS Helpdesk (14) OOS/OOT (2) Procedures (1) Stability (3) Troubleshooting (1) Validation (19) Verification (1) Video (4) Webinar (2)