Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, discuss the ...
In-house harmonization of excipient specifications ensures compliance with multiple pharmacopoeias, reducing redundant testing and aligning with global regulatory expectations. Specification ...
This will allow quality specialists to integrate standards into digital workflows with greater efficiency, consistency, and reduced risk.
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 ...
Wilmington, N.C., March 30, 2011 - AAIPharma Services Corp., a leading provider of pharmaceutical product development and manufacturing services, has relocated its compendial raw materials testing ...
Natural cyclodextrins (CDs) and their synthetically modified derivatives, hydroxypropyl-β-cyclodextrin (HP-β-CD) and sulfobutyl-β-cyclodextrin (SB-β-CD), are widely used in pharmaceuticals as ...
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 ...
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 ...
WILMINGTON, N.C., March 30, 2011 /PRNewswire/ -- AAIPharma Services Corp., a leading provider of pharmaceutical product development and manufacturing services, has relocated its compendial raw ...
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 ...
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