API Department (Quality Assessment)
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Assessment policy
CADIFA Guidance
Impurities
ANVISA Guidelines
Other Guidelines
Pharmacopoeias
ANVISA links
Other links
FAQ
History
Certificates catalogue
CEP - Suspensions, Withdrawals, Restorarions
Prequalified APIs
Prequalified FPPs
WHOPIRs (GMP database)
IARC Monographs
EMA
Eudra GMDP
Nitrosamines
Nitrosamines (ARBs)
DMFs
Nitrosamines
Nitrosamines (ARBs)
Drug Establishments Current Registration Site
Working groups
Quality for generics
ASMF/DMF Database
Lexicon of quality terms
Criteria for when a separate ASMF/DMF should be submitted
Guidance for Quality Assessors – Drug Substance