72 Pharmaceutical Technology REGULATORY SOURCEBOOK OCTOBER 2020 P h a r mTe c h . c o m
Resources: Guidelines
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)
• 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 current as of October 15, 2020.
