ich-q-3-b-r2-impurities-new-drug-products-step-5_en.pdf - European Medicines Agency June 2006 CPMP\/ICH\/2738\/99 ICH Topic Q 3 B(R2 Impurities in New Drug

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European Medicines Agency 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 85 75 Fax (44-20) 75 23 70 40 E-mail: [email protected] ° EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged June 2006 CPMP/ICH/2738/99 ICH Topic Q 3 B (R2) Impurities in New Drug Products Step 5 NOTE FOR GUIDANCE ON IMPURITIES IN NEW DRUG PRODUCTS (CPMP/ICH/2738/99) TRANSMISSION TO CHMP November 1999 TRANSMISSION TO INTERESTED PARTIES November 1999 RELEASE FOR CONSULTATION November 1999 DEADLINE FOR COMMENTS May 2000 APPROVAL BY CPMP February 2003 DATE FOR COMING INTO OPERATION August 2003 REVISED ATTACHMENT 2 June 2006
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© EMEA 2006 2 TABLE OF CONTENTS I. INTRODUCTION 3 1.1 O BJECTIVE OF THE GUIDELINE 3 1.2 B ACKGROUND 3 1.3 S COPE OF THE GUIDELINE 3 II. RATIONALE FOR THE REPORTING AND CONTROL OF DEGRADATION PRODUCTS 3 III. ANALYTICAL PROCEDURES 4 IV REPORTING DEGRADATION PRODUCTS CONTENT OF BATCHES 4 V. LISTING OF DEGRADATION PRODUCTS IN SPECIFICATIONS 5 VI QUALIFICATION OF DEGRADATION PRODUCTS 6 VII GLOSSARY 7 A TTACHMENT 1: T HRESHOLDS FOR D EGRADATION P RODUCTS IN N EW D RUG P RODUCTS 9 E XAMPLE 1: 50 MG M AXIMUM D AILY D OSE 11 E XAMPLE 2: 1.9 GRAM M AXIMUM D AILY D OSE 11 A TTACHMENT 3: D ECISION T REE FOR I DENTIFICATION AND Q UALIFICATION OF A D EGRADATION P RODUCT 13
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© EMEA 2006 3 IMPURITIES IN NEW DRUG PRODUCTS I. INTRODUCTION 1.1 Objective of the guideline This document provides guidance for registration applications on the content and qualification of impurities in new drug products produced from chemically synthesised new drug substances not previously registered in a region or member state. 1.2 Background This guideline is complementary to the ICH Q3A(R) guideline “Impurities in New Drug Substances”, which should be consulted for basic principles. The ICH Q3C guideline “Residual Solvents” should also be consulted, if appropriate. 1.3 Scope of the guideline This guideline addresses only those impurities in new drug products classified as degradation products of the drug substance or reaction products of the drug substance with an excipient and/or immediate container closure system (collectively referred to as “degradation products” in this guideline). Generally, impurities present in the new drug substance need not be monitored or specified in the new drug product unless they are also degradation products (see ICH Q6A guideline on specifications). Impurities arising from excipients present in the new drug product or extracted or leached from the container closure system are not covered by this guideline. This guideline also does not apply to new drug products used during the clinical research stages of development. The following types of products are not covered in this guideline: biological/biotechnological products, peptides, oligonucleotides, radiopharmaceuticals, fermentation products and semi- synthetic products derived therefrom, herbal products, and crude products of animal or plant origin. Also excluded from this document are: (1) extraneous contaminants that should not
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