EMA Eudralex Volume 4 part IV – GMP requirements for Advanced Therapy Medicinal Products
https://health.ec.europa.eu/document/download/ad33d9dd-03f0-4bef-af53-21308ce2187d_en?filename=2017_11_22_guidelines_gmp_for_atmps.pdf
Non classé
ICH Q8/9/10 Points to Consider (R4) : Q8/Q9/Q10 Implementation
https://database.ich.org/sites/default/files/Q8_Q9_Q10_Q%26As_R4_Points_to_Consider_2.pdf
ICH Q5E : Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process
https://database.ich.org/sites/default/files/Q5E%20Guideline.pdf
ICH Q5D : Derivation and Characterization of Cells Substrates Used for Production of Biotechnological/Biological Products
https://database.ich.org/sites/default/files/Q5D%20Guideline.pdf
ICH Q2(R2) : Analytical procedure Development and revision of Q2 (R1) Analytical Validation
https://database.ich.org/sites/default/files/Q2R2-Q14_EWG_Concept_Paper.pdf
ICH Q11 : Development and manufacture of Drug Substances (Chemical entities and biotechnological / biological entities)
https://database.ich.org/sites/default/files/Q11%20Guideline.pdf
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