Guidance related to Active Substances and Excipients

MRHA Guidance

Registration requirements for companies involved in the sourcing and supply of an active substance (AS) to be used in the manufacture of human medicines - Flowcharts

Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland

EU Guidance.

Part II - Basic Requirements for Active Substances used as Starting Materials

Guideline on Active Substance Master File Procedure

Summary of requirements for active substances in the quality part of the dossier

ICH

ICH Q1A (R2): Stability testing of new drug substances and products

ICH Q1D Bracketing and matrixing designs for stability testing of drug substances and drug products

ICH Q3A: “Impurities in New Drug Substances”

ICH Q6A: “Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances”

ICH Q6B: “Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Biotechnological/Biological Products

ICH Q7 - Good manufacturing practice guide for active pharmaceutical ingredients

PIC/S

Guide to Good Manufacturing Practice for Medicinal Products - Annexes - Specifically Annex 3 - Manufacture of radiopharmaceuticals

PIC/S GUIDE TO GOOD PRACTICES FOR THE PREPARATION OF MEDICINAL PRODUCTS IN HEALTHCARE ESTABLISHMENTS - Specifically Annex 3 - Good practices for the preparation of radiopharmaceuticals in healthcare establishments

WHO

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