logging in or signing up Introduction to ICH bharatrbh Download Post to : URL : Related Presentations : Let's Connect Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Copy embed code: Embed: Flash iPad Dynamic Copy Does not support media & animations Automatically changes to Flash or non-Flash embed WordPress Embed Customize Embed URL: Copy Thumbnail: Copy The presentation is successfully added In Your Favorites. Views: 5285 Category: Science & Tech.. License: All Rights Reserved Like it (4) Dislike it (0) Added: July 11, 2010 This Presentation is Public Favorites: 2 Presentation Description No description available. Comments Posting comment... Premium member Presentation Transcript AN INTRODUCTION TO ICH : AN INTRODUCTION TO ICH BY :SWAPNA MASURKAR ARDL - I INDEX : INDEX WHAT IS ICH ? HISTORY INITIATION INTRODUCTION TOPICS QUALITY GUDILINES ICH : ICH INTERNATIONAL CONFERENCE ON HARMONISATION (ICH) OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE. Slide 4: WHAT ? An agreement between the European Union (EU), Japan and the United States (US) Joint initiative between government regulators and industry manufacturers. Slide 5: WHY? to harmonize regulatory requirements for the testing, application and approval process of pharmaceutical medications. Historical Overview : Historical Overview first attempt by the European Commission (EC) member nations during the 1980’s EC began bilateral discussions with both Japan and the United States Slide 7: Specific plans began to materialize at the World Health Organization’s (WHO) Conference on Drug Regulatory Authorities in Paris in 1989 ICH was created in April 1990 at a meeting in Brussels Historical Overview NEED FOR HARMONISATION : NEED FOR HARMONISATION RAPID INCREASE IN LAWS, REGULATIONS ANG GUIDELINES FOR TESTING SAFETY, QUALITY AND EFFICACY OF NEW PRODUCTS DIFFERENT TECHNICAL REQUIREMENTS BY REGULATORY AGENCIES , ALTHOUGH FUNDAMENTAL GUIDING PRINCIPLES SAME INDUSTRY BECOMING GLOBAL DUPLICATION OF TIME CONSUMING AND EXPENSIVE TESTING PROGRESS TOWARDS INTERNATIONAL HARMONISATION : PROGRESS TOWARDS INTERNATIONAL HARMONISATION GOALS : DECREASE COUNTRY-TO-COUNTRY DIFFERENCES IN GUIDELINES DECREASE DIFFERENCES BETWEEN REGULATORY AUTHORITIES Slide 10: TARGET : STREAMLINE DRUG DEVELOPMENT AND REGULATORY PROCESS INCREASE EFFICIENCY AND ENFORCEMENT OF GMP, GLP AND GCP GUIDELIENS PROGRESS TOWARDS INTERNATIONAL HARMONISATION ICH FOUNDER MEMBERS : ICH FOUNDER MEMBERS EUROPEAN UNION : EUROPEAN COMMISSION (EU) EFPIA (EUROPEAN FEDERATION OF PHARMACEUTICAL; INDUSTRIES, ASSOCIATIONS) JAPAN : MINISTERY OF HEALTH AND WELFARE JPMA ( JAPAN PHARMACEUTICAL MANUFACTURERS ASSOCIATION) USA : FDA PhRMA (PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA Initiation of ICH : Initiation of ICH Formation of steering committee Agreement on terms of references Expert working groups Eleven topics Four categories Slide 13: Eleven possible topics to address divided into four main categories SAFETY QUALITY EFFICACY MULTIDISCIPLINARY Slide 14: An ICH Guideline is FDA Guidance Slide 15: STEERING COMMITTEE Monitors and Facilitates EWGs An EWG has 6 Topic Leaders - one from each ICH party Expert Working Groups ICH Steering Committee : ICH Steering Committee Determines the policies and procedures for ICH Selects topics for harmonization Monitors the progress of harmonization initiatives Has two members for each of the six co-sponsors, the IFPMA and Observers Expert Working Groups : Expert Working Groups The Steering Committee assigns an EWG to each of the technical topics selected The groups are comprised of industry specialists on the topics discussed from each of the six members Do not have a fixed membership QUALITY : QUALITY Q1 : STABILITY Q2 : ANALYTICAL VALIDATION Q3 : IMPURITIES Q4 : PHARMACOPOEIAS Q5 : BIOTECHNOLOGICAL QUALITY Q6 : SPECIFIACATIONS Q7 : GMP Q8 : PHARMACEUTICAL DEVELOPMENT Q9 : QUALITY RISK MANAGEMANT Q10: PHARMACEUTICAL QUALITY SYSTEM Q1 Stability Testing : Q1 Stability Testing Q1A(R2) Stability Testing of New Drug Substances and Products Q1B Photostability Testing of New Drug Substances and Products Q1C Stability Testing for New Dosage Forms Slide 20: Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products Q1E Evaluation of Stability Data Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV Q1 Stability Testing Q2 Validation : Q2 Validation Q2(R1) Validation of Analytical Procedures: Text and Methodology Q2A Text on Validation of Analytical Procedures Q2B Validation of Analytical Procedures: Methodology Q3 Impurities : Q3 Impurities Q3A(R) Impurities in New Drug Substances Q3B(R) Impurities in New Drug Products Q3C Impurities: Residual Solvents Q3C Tables and List Q4-Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions : Q4-Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions Annex I: Residue on Ignition/Sulphated Ash General Chapter Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter Slide 24: Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter Slide 25: Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter Slide 26: Annex 5: Disintegration Test General Chapter Annex 6:Uniformity of Dosage Units General Chapter Annex 7:Dissolution Test General Chapter Annex 8: Sterility Test General Chapter Slide 27: Annex 9: Tablet Friability General Chapter Annex 10: Polyacrylamide Gel Electrophoresis General Chapter Annex 11: Capillary ElectrophoresisGeneral Chapter Annex 12: Analytical Sieving General Chapter Q5 BIOTECHNOLOGICAL QUALITY : Q5 BIOTECHNOLOGICAL QUALITY Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products Q5 BIOTECHNOLOGICAL QUALITY : Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process Q5 BIOTECHNOLOGICAL QUALITY Q6 SPECIFICATIONS : Q6 SPECIFICATIONS Q6A International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products Q7A GMP Guidance for APIs : Q7A GMP Guidance for APIs This document is intended : To provide guidance regarding GMP for manufacturing of API under an appropriate system for managing quality To ensure that API meets the requirements of quality and purity Q8(R2) Pharmaceutical Development : Q8(R2) Pharmaceutical Development To design a quality product and its manufacturing process to consistently deliver the intended performance of the product Q9 Quality Risk Management : Q9 Quality Risk Management It provides principles and examples of tools for Quality Risk Management that can be applied to different aspects of pharmaceutical quality such as : Development Manufacturing Distribution Inspection Q10 Pharmaceutical Quality System : Q10 Pharmaceutical Quality System It applies to Drug Substance and Drug Product including biotechnological and biological products throughout the lifecycle of the product. ICH 1 ( NOVEMBER 1991) : ICH 1 ( NOVEMBER 1991) DEVELOPMENT OF TRIPARTITE AGREEMENT ICH 2 (OCTOBER 1993) : ICH 2 (OCTOBER 1993) REVIEW OF PROGRESS TOWARDS HARMONISATION IN AREAS OF : EFFEICACY SAFETY QUALITY ICH 3 ( NOVEMBER 1995) : ICH 3 ( NOVEMBER 1995) UPDATE STATUS OF : TRIPARTITE AGREEMENT PROGRESS TOWARDS HARMONISATION ICH 4 ( JULY 1997) : ICH 4 ( JULY 1997) REIVIEW AND UPDATE OF THE IMPEMENTATION AND IMPACT OF ICH GUIDELINES ICH 5 ( NOEMBER 2000) : ICH 5 ( NOEMBER 2000) COMPLETION OF CTD(M4) ICH 6 ( NOVEMBER 2003) : ICH 6 ( NOVEMBER 2003) continued development of new guidances did work on the implementation of existing guidelines Slide 41: ANY QUESTIONS ? Slide 42: THANK YOU You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.