API Department (Quality Assessment)
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Assessment policy
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CADIFA Guidance
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Impurities
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ANVISA Guidelines
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Other Guidelines
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Pharmacopoeias
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ANVISA links
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Other links
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FAQ
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History
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Quick access
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Legislation database RDC 359/2020 RDC 361/2020 RDC 362/2020 RDC 318/2019 RDC 57/2009 IN 15/2009 IN 3/2013 RDC 200/2017 RDC 73/2016 RDC 166/2017 RDC 45/2012 RDC 69/2014 RDC 204/2005 RDC 53/2015 RDC 301/2019 RDC 37/2011
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Marketing authorizations GMPc Database DCB FB6 - V1 FB6 - V2 Application queue Reference drug products
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General Q Guidelines M Guidelines M4Q (R1) Q1A (R2) Q1B Q1D Q1E Q3A (R2) Q3B (R2) Q3C (R6) Q3D (R1) Q6A Q6A (DTs) Q7 Q8 (R2) Q9 Q10 Q11 Q11 Q&A M7 (R1)
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European Pharmacopoeia CEP Database Reference stantards Knowledge Database
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USP Reference standards
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International Pharmacop. Prequalified APIs
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EudraGMPD