BioPharm International - December 2019

BP1219_Ebook-Regulatory

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www.biopharminternational.com December 2019 BioPharm International eBook 43 Regulatory Sourcebook Resources EUROPEAN MEDICINES AGENCY (EMA) RESOURCES • EMA Biosimilar Medicines • EMA Human Medicines • EMA Marketing Authorization • EMA Medicines Under Evaluation • EMA Post Authorization • EMA Research and Development • EMA Veterinary Medicines EMA GUIDANCE DOCUMENTS • Advanced Therapies: GCP requirements • Advanced Therapies: GLP requirements • Advanced Therapies: GMP Requirements • Biologicals: Active Substance • Biologicals: Finished Product • Good Distribution Practice • Good Laboratory Practice • Good Manufacturing Practice • Biosimilars • Cell Therapy and Tissue Engineering • Gene Therapy • Nanomedicines • Paediatrics • Vaccines • Quality: Active Substance • Quality: Excipients • Quality: Impurities • Quality: Lifecycle Management • Quality: Manufacturing • Quality: Packaging • Quality: Pharmaceutical Development • Quality: Quality by Design • Quality: Specific Types of Products • Quality: Specifications, Analytical Procedures and Analytical Validation • Quality: Stability ICH GUIDELINES (PDF FILES) • Q1A(R2) Stability Testing of New Drug Substances and Products • Q1B Stability Testing: Photostability Testing of New Drug Substances and Products • Q1C Stability Testing for New Dosage Forms • Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products • Q1E Evaluation of Stability Data • Q2(R1) Validation of Analytical Procedures: Text and Methodology • Q2(R2)/Q14 EWG Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation (Concept Paper) • Q3A (R2) Impurities in New Drug Substances • Q3B(R2) Impurities in New Drug Products • Q3C(R6) Maintenance of the Guideline for Residual Solvents • Q3D(R1) Guideline for Elemental Impurities • Q4A–Q4B Pharmacopoeial Harmonization • Q5A(R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin • Q5B Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products • Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products • Q5D Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products • Q5E Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process • Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances • Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products • Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients • Q8(R2) Pharmaceutical Development • Q9 Quality Risk Management • Q10 Pharmaceutical Quality System • Q11 Development and Manufacture of Drug Substances • Q12 EWG Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (Draft Guideline) • Q13 EWG Continuous Manufacturing of Drug Substances and Drug Products (Concept Paper) WORLD HEALTH ORGANIZATION GUIDELINES • Good Data and Records Management (PDF) • Generic Finished Pharmaceuticals (PDF) • Development of Paediatric Medicines (PDF) • Distribution Guidelines • Inspection Guidelines • Good Pharmacopoeial Practices (PDF) • GMPs: Main Principles (PDF) • Stability Testing (PDF) *Information and links current as of Dec. 7, 2019. Catalent .............................................................25 PDA .......................................................................5 USP .....................................................................11 Ad Index COMPANY PAGE

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