The new <1226>, 'Verification of Compendial methods' was published in second supplement to USP 30 - NF 25 (2007) and is now official. Compliance to USP <1226> is one of the FDA requirements for ...

The validation of alternative microbiological testing is an opportunity for a manufacturer to decrease the amount of time required for laboratory results. To properly validate these alternatives, a ...

Dublin, Feb. 27, 2025 (GLOBE NEWSWIRE) -- The "3hr Virtual Seminar - Validation, Verification and Transfer of Analytical Methods - Implementing Guidelines from FDA/EMA, USP and ICH" training has been ...

In-house harmonization of excipient specifications ensures compliance with multiple pharmacopoeias, reducing redundant testing and aligning with global regulatory expectations. Specification ...

The process of method modernization, which involves integrating advancements in system and column technology for routine analysis, is a challenge many regulated laboratories face due to a larger focus ...

DUBLIN--(BUSINESS WIRE)--The "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)" conference has been added to Research ...

Natural cyclodextrins (CDs) and their synthetically modified forms, hydroxypropyl-β-cyclodextrin (HP-β-CD) and sulfobutyl-β-cyclodextrin (SB-β-CD), are critical components in pharmaceutical ...

DUBLIN--(BUSINESS WIRE)--The "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)" conference has been added to ...