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International Conference on Harmonisation

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ICH- (QSEM SYSTEM ):

ICH- (QSEM SYSTEM ) PRESENTED BY- amit verma alok kr vishwakarma mahendra singh bipin katiyar M.PHARM (pharmaceutics)

ICH Guidelines :

ICH Guidelines The ICH Topics are divided into four major categories and ICH Topic Codes are assigned according to these categories. Q "Quality" Topics , i.e., those relating to chemical and pharmaceutical Quality Assurance (Stability Testing, Impurity Testing, etc.) S "Safety" Topics , i.e., those relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.) E "Efficacy" Topics , i.e., those relating to clinical studies in human subject (Dose Response Studies, Good Clinical Practices, etc.) M " Multidisciplinary" Topics , i.e., cross-cutting Topics which do not fit uniquely into one of the above categories (MedDRA, ESTRI, M3, CTD, M5)

ICH may refer to: :

ICH may refer to: The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe , Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration.

PURPOSE OF ICH:

PURPOSE OF ICH The purpose of ICH is to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration. Harmonisation would lead to a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines while maintaining safeguards on quality, safety, and efficacy, and regulatory obligations to protect public health.

About History:

About History In the 1980s, what is today the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation; ICH was created in April 1990 at a meeting in Brussels .

Quality Guidelines New Codification as per November 2005  Stability Q1A(R2) Stability Testing of New Drug Substances and Products Q1B Stability Testing : Photostability Testing of New Drug Substances and Products Q1C Stability Testing for New Dosage Forms 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 Analytical ValidationQ2(R1) New title: Validation of Analytical Procedures: Text and Methodology Previously: Text on Validation of Analytical ProceduresQ2A Validation of Analytical Procedures: Methodology (in Q2(R1))Q2B :

Quality Guidelines New Codification as per November 2005 Stability Q1A(R2) Stability Testing of New Drug Substances and Products Q1B Stability Testing : Photostability Testing of New Drug Substances and Products Q1C Stability Testing for New Dosage Forms 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 Analytical ValidationQ2(R1) New title: Validation of Analytical Procedures: Text and Methodology Previously: Text on Validation of Analytical Procedures Q2A Validation of Analytical Procedures: Methodology (in Q2(R1)) Q2B

ImpuritiesQ3A(R2) Impurities in New Drug SubstancesQ3A(R) Q3B(R2) Impurities in New Drug ProductsQ3B(R) Q3C(R4) Impurities: Guideline for Residual SolventsQ3C Impurities: Guideline for Residual Solvents (Maintenance)PDE for Tetrahydrofuran (in Q3C(R3))Q3C(M) PDE for N-Methylpyrrolidone (in Q3C(R3)):

ImpuritiesQ3A(R2) Impurities in New Drug Substances Q3A(R) Q3B(R2) Impurities in New Drug Products Q3B(R) Q3C(R4) Impurities: Guideline for Residual Solvents Q3C Impurities: Guideline for Residual Solvents (Maintenance)PDE for Tetrahydrofuran (in Q3C(R3)) Q3C(M) PDE for N-Methylpyrrolidone (in Q3C(R3))

PharmacopoeiasQ4 Pharmacopoeias Q4A Pharmacopoeial Harmonisation Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Q4B  Annex 1(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue on Ignition/Sulphated Ash General Chapter Q4B  Annex 2(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations General Chapter Q4B  Annex 3(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles General Chapter :

PharmacopoeiasQ4 Pharmacopoeias Q4A Pharmacopoeial Harmonisation Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Q4B Annex 1(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue on Ignition/Sulphated Ash General Chapter Q4B Annex 2(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations General Chapter Q4B Annex 3(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles General Chapter

Q4B  Annex 4A(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter Q4B  Annex 4B(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter Q4B Annex 4C(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter Q4BAnnex 5(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test General Chapter  :

Q4B Annex 4A(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter Q4B Annex 4B(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter Q4B Annex 4C(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter Q4BAnnex 5(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test General Chapter

Q4B  Annex 6(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of Dosage Units General Chapter Q4B Annex 7(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Dissolution Test General Chapter Q4B Annex 8(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Sterility General Chapter Q4B Annex 9(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Tablet Friability General Chapter Q4B Annex 10(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Polyacrylamide Gel Electrophoresis General Chapter:

Q4B Annex 6(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of Dosage Units General Chapter Q4B Annex 7(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Dissolution Test General Chapter Q4B Annex 8(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Sterility General Chapter Q4B Annex 9(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Tablet Friability General Chapter Q4B Annex 10(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Polyacrylamide Gel Electrophoresis General Chapter

Q4B  Annex 11 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Capillary Electrophoresis General Chapter Q4B Annex 12 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Analytical Sieving General Chapter Q4B Annex 13 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bulk Density and Tapped Density of Powders General Chapter Q4B Annex 14 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bacterial Endotoxins Test General Chapter:

Q4B Annex 11 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Capillary Electrophoresis General Chapter Q4B Annex 12 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Analytical Sieving General Chapter Q4B Annex 13 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bulk Density and Tapped Density of Powders General Chapter Q4B Annex 14 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bacterial Endotoxins Test General Chapter

Quality of Biotechnological ProductsQ5A(R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal OriginQ5A Q5B Quality of Biotechnological Products : Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products Q5C Quality of Biotechnological Products : Stability Testing of Biotechnological/Biological Products Q5D Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products Q5E Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process :

Quality of Biotechnological ProductsQ5A(R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin Q5A Q5B Quality of Biotechnological Products : Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products Q5C Quality of Biotechnological Products : Stability Testing of Biotechnological/Biological Products Q5D Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products Q5E Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process

SpecificationsQ6A Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (including Decision Trees) Q6B Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products Good Manufacturing Practice Q7 Good Manufacturing Practice Guide for Active Pharmaceutical IngredientsQ7A Pharmaceutical Development Q8(R2) Pharmaceutical Development Quality Risk Management-Q9 Quality Risk Management Pharmaceutical Quality System-Q10 Pharmaceutical Quality System:

SpecificationsQ6A Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (including Decision Trees) Q6B Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products Good Manufacturing Practice Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7A Pharmaceutical Development Q8(R2) Pharmaceutical Development Quality Risk Management-Q9 Quality Risk Management Pharmaceutical Quality System-Q10 Pharmaceutical Quality System

Efficacy Guidelines New Codification as per November 2005  Previously coded: Clinical Safety E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting E2B(R3) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety ReportsE2B(M) E2C(R1) Clinical Safety Data Management: Periodic Safety Update Reports for Marketed DrugsE2C Addendum to E2C: Periodic Safety Update Reports for Marketed Drugs (in E2C(R1))E2CAE2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting E2E Pharmacovigilance Planning E2F Development Safety Update Report :

Efficacy Guidelines New Codification as per November 2005 Previously coded: Clinical Safety E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting E2B(R3) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports E2B(M) E2C(R1) Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs E2C Addendum to E2C: Periodic Safety Update Reports for Marketed Drugs (in E2C(R1)) E2CA E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting E2E Pharmacovigilance Planning E2F Development Safety Update Report

Clinical Study Reports E3 Structure and Content of Clinical Study Reports Dose-Response Studies E4 Dose-Response Information to Support Drug Registration Ethnic Factors E5(R1) Ethnic Factors in the Acceptability of Foreign Clinical DataE5 Good Clinical Practice E6(R1) Good Clinical PracticeE6 :

Clinical Study Reports E3 Structure and Content of Clinical Study Reports Dose-Response Studies E4 Dose-Response Information to Support Drug Registration Ethnic Factors E5(R1) Ethnic Factors in the Acceptability of Foreign Clinical Data E5 Good Clinical Practice E6(R1) Good Clinical Practice E6

Clinical TrialsE7 Studies in Support of Special Populations: Geriatrics E8 General Consideration of Clinical Trials E9 Statistical Principles for Clinical Trials E10 Choice of Control Group and Related Issues in Clinical Trials E11 Clinical Investigation of Medicinal Products in the Pediatric Population:

Clinical TrialsE7 Studies in Support of Special Populations: Geriatrics E8 General Consideration of Clinical Trials E9 Statistical Principles for Clinical Trials E10 Choice of Control Group and Related Issues in Clinical Trials E11 Clinical Investigation of Medicinal Products in the Pediatric Population

Guidelines for Clinical Evaluation by Therapeutic CategoryE12 Principles for Clinical Evaluation of New Antihypertensive DrugsE12 Clinical EvaluationE14 The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs PharmacogenomicsE15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics,  Genomic Data and Sample Coding Categories E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions     :

Guidelines for Clinical Evaluation by Therapeutic CategoryE12 Principles for Clinical Evaluation of New Antihypertensive Drugs E12 Clinical EvaluationE14 The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs PharmacogenomicsE15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions

Safety Guidelines New Codification as per November 2005Previously coded: Carcinogenicity Studies S1A Need for Carcinogenicity Studies of Pharmaceuticals S1B Testing for Carcinogenicity of Pharmaceuticals S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals :

Safety Guidelines New Codification as per November 2005 Previously coded: Carcinogenicity Studies S1A Need for Carcinogenicity Studies of Pharmaceuticals S1B Testing for Carcinogenicity of Pharmaceuticals S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals

Safety Guidelines New Codification as per November 2005Previously coded: Carcinogenicity Studies S1A Need for Carcinogenicity Studies of Pharmaceuticals S1B Testing for Carcinogenicity of Pharmaceuticals S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals :

Safety Guidelines New Codification as per November 2005 Previously coded: Carcinogenicity Studies S1A Need for Carcinogenicity Studies of Pharmaceuticals S1B Testing for Carcinogenicity of Pharmaceuticals S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals

Genotoxicity Studies S2A Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals  S2(R1) Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals (in S2(R1))S2A Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals (in S2(R1))S2B Toxicokinetics and PharmacokineticsS3A Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies:

Genotoxicity Studies S2A Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals S2(R1) Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals ( in S2(R1) ) S2A Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals ( in S2(R1) ) S2B Toxicokinetics and PharmacokineticsS3A Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies

Toxicity TestingS4 Single Dose Toxicity TestsS4 S4 Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing)S4A Reproductive ToxicologyS5(R2) New title: Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility Previously: Detection of Toxicity to Reproduction for Medicinal ProductsS5A Maintenance of the ICH Guideline on Toxicity to Male Fertility: An Addendum to the Guideline on Detection of Toxicity to Reproduction for Medicinal Products (in S5(R2)):

Toxicity TestingS4 Single Dose Toxicity Tests S4 S4 Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing) S4A Reproductive ToxicologyS5(R2) New title: Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility Previously: Detection of Toxicity to Reproduction for Medicinal Products S5A Maintenance of the ICH Guideline on Toxicity to Male Fertility: An Addendum to the Guideline on Detection of Toxicity to Reproduction for Medicinal Products (in S5(R2))

Biotechnological Products S6  Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1) Addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals Pharmacology StudiesS7A Safety Pharmacology Studies for Human PharmaceuticalsS7B The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals Immunotoxicology StudiesS8 Immunotoxicity Studies for Human Pharmaceuticals S9 Nonclinical Evaluation for Anticancer Pharmaceuticals Joint Safety/Efficacy  (Multidisciplinary) TopicM3(R2)  Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals:

Biotechnological Products S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1) Addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals Pharmacology StudiesS7A Safety Pharmacology Studies for Human Pharmaceuticals S7B The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals Immunotoxicology StudiesS8 Immunotoxicity Studies for Human Pharmaceuticals S9 Nonclinical Evaluation for Anticancer Pharmaceuticals Joint Safety/Efficacy  (Multidisciplinary) TopicM3(R2) Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

Multidisciplinary Guidelines   M1MedDRA Medical Terminology   M2ESTRI Electronic Standards for the Transfer of Regulatory Information   M3M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals   M4CTD The Common Technical Document   M5M5 Data Elements and Standards for Drug Dictionaries  :

Multidisciplinary Guidelines M1MedDRA Medical Terminology M2ESTRI Electronic Standards for the Transfer of Regulatory Information M3M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M4CTD The Common Technical Document M5M5 Data Elements and Standards for Drug Dictionaries

M1 Medical Terminology :The working group has provided a new Medical Dictionary for Regulatory Activities Terminology (MedDRA Terminology) that is intended for international adoption. It is designed to support the classification, retrieval, presentation and communication of medical information throughout the medical product regulatory/life cycle. Its goal is to provide a comprehensive and specific terminology to help standardize, facilitate and simplify regulatory processes.   M2 Electronic Standards for Transmission of Regulatory Information (ESTRI)       :

M1 Medical Terminology : The working group has provided a new Medical Dictionary for Regulatory Activities Terminology (MedDRA Terminology) that is intended for international adoption. It is designed to support the classification, retrieval, presentation and communication of medical information throughout the medical product regulatory/life cycle. Its goal is to provide a comprehensive and specific terminology to help standardize, facilitate and simplify regulatory processes. M2 Electronic Standards for Transmission of Regulatory Information (ESTRI)

M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals This multidisciplinary document addresses principles for the development of non-clinical strategies on the timing of toxicity studies in relation to the conduct of clinical trials. The guideline represents an important step forward on requirements for the different phases of clinical development but it is recognised that there remain some further important issues yet to be resolved.   M4 The Common Technical Document The Common Technical Document provides for a harmonised structure and format for new product applications. The Common Technical Document was agreed upon in November 2000 in San Diego, USA. This Common Technical Document is divided into four separate sections. The four sections address the application organisation (M4 organise), the Quality section (M4Q), the Safety section (M4S) and the Efficacy section (M4E) of the harmonised application. The agreed upon implementation date for the Common Technical Document, in the three regions, was July 2003.:

M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals This multidisciplinary document addresses principles for the development of non-clinical strategies on the timing of toxicity studies in relation to the conduct of clinical trials. The guideline represents an important step forward on requirements for the different phases of clinical development but it is recognised that there remain some further important issues yet to be resolved. M4 The Common Technical Document The Common Technical Document provides for a harmonised structure and format for new product applications. The Common Technical Document was agreed upon in November 2000 in San Diego, USA. This Common Technical Document is divided into four separate sections. The four sections address the application organisation (M4 organise), the Quality section (M4Q), the Safety section (M4S) and the Efficacy section (M4E) of the harmonised application. The agreed upon implementation date for the Common Technical Document, in the three regions, was July 2003.

Scientific approach to stability:

Scientific approach to stability

Stability protocol - API:

Stability protocol - API Protocol Parameter Description Storage conditions (including tolerances) and testing frequency 25°C/60% RH 0, 3, 6, 9, 12, (18, 24, 36) months 30 o C/75% RH 0, 3, 6, 9,12, (18, 24, 36) months 40°C/75% RH 0,3,6 months Batch number and size L40438 ( Jan. 2005 ), 80.50 k g L50041 ( Feb.2005 ), 69.00 k g L50054 (March 2005 ), 73.00 kg Container closure system(s) double PE bags in black PE bag kept in one-kg fib er board drums well-closed Tests and acceptance criteria Assay by(98.0-102.0%), ImpA (NMT 0.15%), ImpB (NMT0.3%), and so on Other (s) Stress testing, including photostability testing according to ICH Q1B

Protocol Parameter Description:

Protocol Parameter Description Storage conditions ( including tolerances ) and testing frequency 25°C/60% RH 0, 3, 6, 9, 12, (18, 24, 36) months 30 o C/75% RH 0, 3, 6, 9,12, (18, 24, 36) months 40°C/75% RH 0,3,6 months Batch numbers and size NEV 40438 ( Jan. 200 7), 4000 bottles (960 liters) NEV 50 439 (Jan .200 7), 4000 bottles (960 liters) NEV 50 440 (Jan. 200 7), 4000 bottles (960 liters) Container closure system(s) proposed for marketing White HDPE bottle with two piece child-resistant closure Tests and acceptance criteria Assay (95.0-105.0%), there are no degradants , dissolution testing (and profile), in-use stability test , preservative contents, antimicrobial preservative effectiveness , re-suspendibility (sedimentation rate)

STRESS TESTING:

STRESS TESTING Stress testing – API Studies undertaken to elucidate the intrinsic stability of the active pharmaceutical ingredient. Such testing is part of the development strategy and is normally carried out under more severe conditions than those used for accelerated testing. Stress testing – FPP Studies undertaken to assess the effect of severe conditions on the pharmaceutical product . Such studies include photostability testing and specific testing on certain products, (e.g. metered dose inhalers, creams, emulsions, refrigerated aqueous liquid products).

Stress testing (forced degradation):

Stress testing (forced degradation) Degradation factor Conditions Thermal ≥ 60 o C Humidity ≥ 75% RH Acid 0.1N HCl Base 0.1N NaOH Oxidative Oxygen gas, or 3% H 2 O 2 Photolytic Metal halide, Hg, Xe lamp, or UV-B fluorescent Metal ions (optional) 0.05M Fe 2+ or Cu 2+

Structure of ICH ICH is comprised of Six Parties that are directly involved, as well as three Observers and IFPMA.:

Structure of ICH ICH is comprised of Six Parties that are directly involved, as well as three Observers and IFPMA . The Observers are WHO, EFTA, and Canada (represented by Health Canada). ICH is operated via the ICH Steering Committee , which is supported by ICH Coordinators and the ICH Secretariat . ICH Parties European Commission - European Union (EU) The European Commission represents the 27 members of the EU. European Federation of Pharmaceutical Industries and Associations (EFPIA) Ministry of Health, Labour and Welfare, Japan (MHLW) The Ministry of Health, Labour and Welfare has responsibilities for approval and administration of drugs, medical devices and cosmetics in Japan. Japan Pharmaceutical Manufacturers Association (JPMA) JPMA represents 75 members (including 20 foreign affiliates) and 14 committees. Membership includes all the major research-based pharmaceutical manufacturers in Japan.

US Food and Drug Administration (FDA) The US Food and Drug Administration has a wide range of responsibilities for drugs, biologicals, medical devices, cosmetics and radiological products. PhRMA which was previously known as the US Pharmaceutical Manufacturers Association (PMA), coordinates its technical input to ICH through its Scientific and Regulatory Section. ICH Observers Since ICH was initiated, in 1990, there have been observers to act as a link with non-ICH countries and regions. The ICH Observers are: The World Health Organisation (WHO) The European Free Trade Association (EFTA), IFPMA The International Federation of Pharmaceutical Manufacturers & Associations is a non-profit, non-governmental Organization (NGO) representing national industry associations and companies from both developed and developing countries. Member companies of the IFPMA are research-based pharmaceutical, biotech and vaccine companies. IFPMA provides the ICHSecretariat. :

US Food and Drug Administration (FDA) The US Food and Drug Administration has a wide range of responsibilities for drugs, biologicals, medical devices, cosmetics and radiological products. PhRMA which was previously known as the US Pharmaceutical Manufacturers Association (PMA), coordinates its technical input to ICH through its Scientific and Regulatory Section. ICH Observers Since ICH was initiated, in 1990, there have been observers to act as a link with non-ICH countries and regions. The ICH Observers are: The World Health Organisation (WHO) The European Free Trade Association (EFTA), IFPMA The International Federation of Pharmaceutical Manufacturers & Associations is a non-profit, non-governmental Organization (NGO) representing national industry associations and companies from both developed and developing countries. Member companies of the IFPMA are research-based pharmaceutical, biotech and vaccine companies. IFPMA provides the ICHSecretariat .

ICH Steering Committee ICH is administered by the ICH Steering Committee which is supported by the ICH Secretariat. The ICH Steering Committee (SC) was established in April 1990, when ICH was initiated. determines the policies and procedures for ICH, selects topics for harmonisation . ICH Coordinator act as the main contact point with the ICH Secretariat and ensure that ICH documents are distributed to the appropriate persons within the area of their responsibility. :

ICH Steering Committee ICH is administered by the ICH Steering Committee which is supported by the ICH Secretariat . The ICH Steering Committee (SC) was established in April 1990, when ICH was initiated. determines the policies and procedures for ICH, selects topics for harmonisation . ICH Coordinator act as the main contact point with the ICH Secretariat and ensure that ICH documents are distributed to the appropriate persons within the area of their responsibility.

The ICH Secretariat The Secretariat operates from the IFPMA offices, in Geneva, and is primarily concerned with preparations for, and documentation of, meetings of the Steering Committee as well as coordination of preparations for Working Group and Discussion Group meetings. Secretariat is responsible for the technical documentation and for liaison with the speakers for the Conference. :

The ICH Secretariat The Secretariat operates from the IFPMA offices, in Geneva, and is primarily concerned with preparations for, and documentation of, meetings of the Steering Committee as well as coordination of preparations for Working Group and Discussion Group meetings. Secretariat is responsible for the technical documentation and for liaison with the speakers for the Conference.

THANKS.:

THANKS.

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