Dublin, Feb. 13, 2025 (GLOBE NEWSWIRE) -- The "Analytical Method Validation, Verification and Transfer Course" training has been added to ResearchAndMarkets.com's offering. Dependable analytical ...
Biopharmaceuticals – or biologics – are a rapidly growing segment of the global pharmaceutical market that has revolutionized the management of hard-to-treat diseases such as cancer and autoimmune ...
Analytical procedure performance can be continually verified by risk-based monitoring of performance related data. The principles of quality by design (QbD) and life cycle management, as outlined in ...
Are you ready for ICH Q14: Analytical Procedure Development and the revision of ICHQ2(R1) Analytical Validation? These guidance’s, intended to be published by 2021, complement Q8 to Q12 and aim to ...
QC laboratories perform a critical role in demonstrating pharmaceutical products are consistently manufactured, safe, potent, and pure. At the same time, the number of tests run by QC laboratories is ...
In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA ...
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