Chemistry of active substances (chemistry of new active substances)
Table of contents
This document describes the type of information required for the manufacture and control of active substances (existing or new chemical entities) used in a medicinal product.
Keywords: Active substance, chemistry, dossier, manufacture, quality control, impurities, specification
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Guideline on the chemistry of active substances (PDF/203.56 KB)
Adopted
First published: 21/11/2016
Last updated: 21/11/2016
Legal effective date: 21/01/2017
EMA/454576/2016 -
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Overview of comments received on 'Draft guideline on the chemistry of active substances’ (EMA/CHMP/QWP/96664/2015) (PDF/751.12 KB)
First published: 21/11/2016
Last updated: 21/11/2016
EMA/454577/2016 -
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Draft guideline on the chemistry of active substances (human) (PDF/188.39 KB)
Draft: consultation closed
First published: 24/04/2015
Last updated: 24/04/2015
Consultation dates: 24/04/2015 to 24/10/2015
EMA/CHMP/QWP/96664/2015 -
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Concept paper on the need for a single note for guidance on the chemistry of active substances (PDF/81.29 KB)
Draft: consultation closed
First published: 10/02/2014
Last updated: 10/02/2014
Consultation dates: 10/02/2014 to 10/08/2014
EMA/CHMP/QWP/752676/2013 -
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Chemistry of active substances - Superseded document (PDF/36.37 KB)
Adopted
First published: 01/10/2015
Last updated: 01/10/2015
Legal effective date: 01/10/2015
3AQ5A -
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Chemistry of new active substances - Superseded document (PDF/207.78 KB)
Adopted
First published: 17/12/2003
Last updated: 17/12/2003
Legal effective date: 01/02/2004
CPMP/QWP/130/96 Rev. 1
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Control of impurities of pharmacopoeial substances: compliance with the European Pharmacopoeia general monograph Substances for pharmaceutical use and general chapter Control of impurities in substances for pharmaceutical use
- Eudralex - Volume 4 Good manufacturing practice (GMP) Guidelines, Annex 16: Certification by a Qualified Person and Batch Release
- Active substance master file procedure
- ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
- ICH Q1A (R2) Stability testing of new drug substances and drug products
- ICH Q1B Photostability testing of new active substances and medicinal products
- ICH Q2(R1) Validation of analytical procedures: text and methodology
- ICH Q3A (R2) Impurities in new drug substances
- ICH Q3C (R5) Residual solvents
- ICH Q6A Specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances
- ICH Q7 Good manufacturing practice for active pharmaceutical ingredients
- ICH Q11 Development and manufacture of drug substances (chemical entities and biotechnological/biological entities)
- Investigation of chiral active substances
- Limits of genotoxic impurities
- Plastic primary packaging materials
- Quality of water for pharmaceutical use
- Setting specifications for related impurities in antibiotics
- Specification limits for residues of metal catalysts
- Stability testing of existing active ingredients and related finished products
- Summary of requirements for active substances in the quality part of the dossier
- Template for the qualified person's (QP) declaration concerning good manufacturing practice compliance of active substance manufacture 'The QP declaration template'