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Guidelines Quality Revision/Renewal of CEPs Suspension and Withdrawal of CEPs ICH Q3D & CEP How to read a CEP

Guidelines TRS 970 Annex 4 (Quality) TRS 981 Annex 3 Amendments to APIMFs ICH Q3D & APIMFs

Guidelines Chemistry of active substances ASMF Procedure Variations (2013/C 223/01) Stability testing for variations to a MA Residual solvents (Annexes) Specifications for related impurities in antibiotics. QP declaration template Sterilisation

Guidelines ANDAs: Pharmaceutical Solid Polymorphism Post-approval Changes to Drug Substances

Quality Post‐Notice of Compliance