www.biopharminternational.com 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Products, Draft Guidance (PDF)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Industry, Draft Guidance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Draft Guidance (PDF)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.