Methods validation

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07
Jul
Are Your Analytical Method Validation Protocols Keeping Up with Evolution in Industry

Are Your Analytical Method Validation Protocols Keeping Up with Evolution in Industry?

By    Jul 07, 2026    Compliance Methods validation Validation

Analytical method validation performed in industry is undergoing a significant transformation—and if your analytical method validation protocol templates haven’t evolved, now is the time to take a closer look. The United States Pharmacopeia (USP) has proposed a revision to USP <1225>, Validation of Analytical Procedures. This update brings the chapter into closer alignment with ICH Q2(R2) […]

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19
Jul

Is It Time to Revisit USP <1058>?

By    Jul 19, 2022    Analytical Methods FDA Methods Methods validation Science & Technology

With the issuance of draft ICH Quality Guideline ICH Q14 on Analytical Procedure Development (here) and revision of ICH Q2(R2) Guideline on Validation of Analytical Procedures (here), along with the issuance of USP <1220> Analytical Procedure Lifecycle, perhaps it may be time to revisit USP <1058> Analytical Instrument Qualification (AIQ). USP <1058> is a critical chapter providing key guidance on […]

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