Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, discuss the ...
Standardizing on Ph. Eur. methods generally ensures compliance with USP–NF and JP requirements, applying the tightest acceptance criteria for multi-compendial compliance. Differences in compendial ...
The growing complexity of the field reinforces the need for standards ensuring product quality, consistency, and patient ...
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 ...
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 ...
Expert: FDA’s draft guidance on particle inspections takes different approach than compendial method
A former US Food and Drug Administration (FDA) official said the agency’s draft guidance on setting up inspection testing programs for detecting visible particles in injectable drugs is meant to ...
The Online Services portal gives customers of AAIPharma Services the flexibility to select the pharmacopeia, material and tests from a database; enter the number of preparations, special instructions ...
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 ...
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