ICH guidelines – “Q” series (quality guidelines) - A review
DOI:
https://doi.org/10.30574/gscbps.2019.6.3.0034Keywords:
ICH guidelines, Q- series, Harmonization, Stability studies, GMPAbstract
ICH- international council for harmonization of technical requirements for pharmaceuticals for human use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. ICH mission is to achieve greater harmonization worldwide to ensure that safe, effective and high quality medicines are developed and registered in the most resource –efficient manner. Harmonization achievements in quality area include pivotal milestone such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more manufacturing practice (GMP) risk management.
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ICH Q1A (R2) - stability testing of new drug substances and products.
ICHQ1B-stability testing: photo stability testing of new drug substances and products.
ICH Q1C- stability testing for new dosage forms.
ICH Q1D- bracketing and matrixing design for stability testing of new drug substances and products.
ICH Q1E- evaluation of stability data.
ICH Q2 (R1)-validation of analytical procedures: text and methodology.
ICHQ3A (R2)-impurities in new drug substances.
ICHQ3B (R2)-impurities in new drug products.
ICHQ3C (R5)-impurities: guidelines for residual solvents.
ICHQ3D-guidelines for elemental impurities.
ICHQ4B-pharmacopeias
ICHQ5A (R1)-viral safety evaluation of biotechnology products derived from cell lines of human or animal origin.
ICHQ5b- analysis of the expression construct in cells used for production of R-DNA derived protein products.
ICHQ5C-stability testing of biotechnological/biological products.
ICHQ5D- derivation and characterization of cell subtracts used for production of biotechnological/biological products.
ICHQ5E-comparability of biotechnological/biological products subject to changes in their manufacturing process.
ICHQ6A-specifications: test procedure and acceptance criteria for new drug substances and new drug products: chemical substances.
ICHQ6B-specification: test procedures and acceptance criteria for biotechnological/biological products.
ICHQ7-good manufacturing practice guide for active pharmaceutical ingredients.
ICHQ8 (R2)-pharmaceutical development
ICHQ9-quality risk management
ICHQ10-pharmaceutical quality system
ICHQ11-development and manufacture of drug substances (chemical entities and bio technological/biological entities.).
ICHQ12-technical and regulatory considerations for pharmaceutical product life cycle management.
ICHQ13-continous manufacturing of drug substances and drug products.
ICHQ14- analytical procedure development.
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