BioPharm International - March 2021

BioPharm International - Regulatory Sourcebook - March 2021

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Page 42 of 47 March 2021 BioPharm International eBook 43 Regulatory Sourcebook Resources • Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry (PDF) • Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products, Draft Guidance (PDF) • Elemental Impurities in Drug Products Guidance for Industry (PDF) • Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry, Draft Guidance • Human Gene Therapy for Rare Diseases (PDF) • INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information (PDF) • PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (PDF) • Postapproval Changes to Drug Substances Guidance for Industry, Draft Guidance (PDF) • Preparation of Investigational New Drug Products (Human and Animal) • Process Validation: General Principles and Practices (PDF) • Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations • Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (PDF) 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) *Information and links current as of March 9, 2021.

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