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dustry, Draft Guidance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Guidance for Industry, Draft Guidance (PDF)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facturing, Draft Guidance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ations Guidance for Industry, Draft Guidance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ance for Industry, Draft Guidance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
