54 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 P h a r mTe c h . c o m
WORLDWIDE
The following are some notable resources from
the World Health Organization (WHO) and the
International Council for Harmonization (ICH)*:
WHO
• WHO Resources
• WHO Regulation Information
• WHO Biologics Information
• WHO Drug Safety
ICH Resources
• ICH Guidelines
• ICH Reflection Papers
• ICH Training
ICH Guidelines
• Q1A(R2) Stability Testing of New Drug
Substances and Products
• Validation of Analytical Procedures:
Text and Methodology Q2(R1)
• Impurities in New Drug Substances Q3A(R2)
• Impurities in New Drug Products Q3B(R2)
• Impurities: Guideline for Residual Solvents
Q3C(R7)
• Guideline for Elemental Impurities Q3D(R1)
• Viral Safety Evaluation of Biotechnology
Products Derived From Cell Lines of Human
Or Animal Origin Q5A(R1)
• Quality of Biotechnological Products:
Analysis of the Expression Construct in Cells
Used for Production of R-DNA Derived
Protein Products Q5B
• Quality of Biotechnological Products:
Stability Testing of Biotechnological/
Biological Products Q5C
• Derivation and Characterisation of Cell
Substrates Used for Production of
Biotechnological/Biological Products Q5D
• Comparability of Biotechnological/Biological
Products Subject to Changes in their
Manufacturing Process Q5E
• Specifications: Test Procedures and
Acceptance Criteria for New Drug Substances
and New Drug Products: Chemical Substances
Q6A
• Specifications: Test Procedures and
Acceptance Criteria for Biotechnological/
Biological Products Q6B
• Q7 Good Manufacturing Practice Guidance
for Active Pharmaceutical Ingredients
Questions and Answers Guidance for Industry
• Pharmaceutical Development Q8(R2)
• Quality Risk Management Q9
• Pharmaceutical Quality System Q10
• Q11 Development and Manufacture of Drug
Substances—Questions and Answers
(Chemical Entities and Biotechnological/
Biological Entities)
• Technical and Regulatory Considerations for
Pharmaceutical Product Lifecycle
Management Q12
* Information correct as of September 16, 2019.
Resources: Guidelines
Contec ....................................................................................................23
Eppendorf NA ........................................................................................27
Eurofins ..................................................................................................17
PDA ...................................................................................................11, 55
Sartorius Stedim NA Inc........................................................................51
Veltek Associates ....................................................................................3
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