Chemistry of active substances (chemistry of new active substances)
Table of contents
| Keywords | Active substance, chemistry, dossier, manufacture, quality control, impurities, specification |
| Description | 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. |
-
List item
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 -
List item
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 -
List item
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 -
List item
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 -
List item
Chemistry of active substances - Superseded document (PDF/36.37 KB)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 -
List item
Chemistry of new active substances - Superseded document (PDF/207.78 KB)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
-
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'