Pharmaceutical Technology - December 2019

Pharmaceutical Technology - Regulatory Sourcebook

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42 Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 P h a r mTe c h . c o m Resources: Guidelines • Elemental Impurities in Drug Products Guid- ance for Industry (PDF) • Guidance for Industry–Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Proto- col for Sterile Products (PDF) • Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for In- dustry, Draft Guidance • INDs for Phase 2 and Phase 3 Studies Chem- istry, Manufacturing, and Controls Informa- tion (PDF) • NDAs: Impurities in Drug Substances (PDF) • PAT—A Framework for Innovative Pharma- ceutical 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Manufacturing, and Quality Assurance (PDF) • Postapproval Changes to Drug Substances Guidance for Industry, Draft Guidance (PDF) • Preparation of Investigational New Drug Products (Human and Animal) (PDF) • Process Validation: General Principles and Practices (PDF) • Quality Considerations for Continuous Manu- facturing, Draft Guidance • Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regu- lations (PDF) • Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice (PDF) • Transdermal and Topical Delivery Systems– Product Development and Quality Consider- ations Guidance for Industry, Draft Guidance • Using the Inactive Ingredient Database Guid- ance for Industry, Draft Guidance European Medicines Agency (EMA) EMA Biosimilar Medicines EMA Human Medicines EMA Marketing Authorization EMA Medicines Under Evaluation EMA Post Authorization EMA Research and Development EMA Veterinary Medicines Select EMA Guidance Documents • Advanced Therapies: GCP requirements • Advanced Therapies: GLP requirements • Advanced Therapies: GMP requirements • Biologicals: Active Substance • Biologicals: Finished Product • Good Distribution Practice (GDP) • Good Laboratory Practice (GLP) • Good Manufacturing Practice (GMP) • 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 Proce- dures and Analytical Validation • Quality: Stability

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