Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2020 51
• 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
Select ICH Guidelines (PDF files)
• Q1A(R2) Stability Testing of New Drug Sub-
stances 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 Sta-
bility Testing of New Drug Substances and Prod-
ucts
• Q1E Evaluation of Stability Data
• Q2(R1) Validation of Analytical Procedures: Text
and Methodology
• Q2(R2)/Q14 EWG Analytical Procedure Develop-
ment and Revision of Q2 (R1) Analytical Valida-
tion (Concept Paper)
• Q3A (R2) Impurities in New Drug Substances
• Q3B(R2) Impurities in New Drug Products
• Q3C(R6) Maintenance of the Guideline for Resid-
ual 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 Pro-
tein Products
• Q5C Quality of Biotechnological Products: Stabil-
ity Testing of Biotechnological/Biological Products
• Q5D Derivation and Characterisation of Cell Sub-
strates Used for Production of Biotechnological/
Biological Products
• Q5E Comparability of Biotechnological/Biological
Products Subject to Changes in their Manufactur-
ing Process
• Q6A Specifications: Test Procedures and Accep-
tance Criteria for New Drug Substances and New
Drug Products: Chemical Substances
• Q6B Specifications: Test Procedures and Accep-
tance Criteria for Biotechnological/Biological
Products
• Q7 Good Manufacturing Practice Guide for Ac-
tive Pharmaceutical Ingredients
• Q8(R2) Pharmaceutical Development
• Q9 Quality Risk Management
• Q10 Pharmaceutical Quality System
• Q11 Development and Manufacture of Drug Sub-
stances
• Q12 EWG Technical and Regulatory Consider-
ations for Pharmaceutical Product Lifecycle Man-
agement (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 as of March 13, 2020.
