Basics Of GCP

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Basics of Good Clinical Practice :

Basics of Good Clinical Practice By: Kirtikrushna

Guidelines for conducting clinical research:

Guidelines for conducting clinical research Belmont report Nuremberg code CIOMS GUIDELINES ICH-GCP Guidelines

History of ICH-GCP:

History of ICH-GCP Historical disasters-----legislations country wise Safety ,efficacy and quality made mandatory ,but each country had its own guidelines. Industry was moving towards globalization but each country had to register at a national level. Global market required repetition of tests –cost and time increased.

History of ICH-GCP:

History of ICH-GCP Joint European Community mission meeting in Japan .Representatives of European commission,Europian Federation of Pharmaceutical industries association.m A project of harmonisation of regulatory guidelines was conceived which came into force from 1989..m

ICH :

ICH ICH= International Conference on Harmonization

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A steering committee was formed comprising of 1.representatives of Europian commission(EU) 2.USFDA. 3.Koseisho(Japanese Ministry of health,Labour and and Welfare,MHLW Japan) 4.International Federation of Pharmaceutical Manufacturers Association(IFPMA), 5.Pharmaceutical research and manufacturers of America(PhRMA) 6.Japan Pharmaceutical Manufacturers association(JPMA) 7.Observers from WHO,Canada,Switzerland 1-6 ARE CALLED FOUNDER MEMBERS OF ICH.

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ICH-International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. 1 st meeting in 1990 at Brussels hosted by EFPIA Meets twice a year at one of the three places,US,Japan,Europe.

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Plan of action was initiated at WHO Conference of Drug Regulatory Authorities(ICDRA) in PARIS 1989. Meeting between ICDRA and IFPMA TO Formulate joint a joint regulatory industry initiative on international hormonisation which gave birth to ICH

Objective of ICH:

Objective of ICH To improve through harmonisation,the efficiency of the process for developing and registering new medicine in Europe,Japan and United states so that these products can be provided to patients with minimum of delay.

ICH Guidelines - Topics:

ICH Guidelines - Topics Divided into 4 major categories & ICH Topic Codes are assigned according to these categories QSEM quality efficacy safety Multidisciplinary.

Quality:

Quality Related to chemical and pharmaceutical quality assurance Q1-Q-7

SAFETY:

SAFETY In vitro and in vivo preclinical studies S1 Carcinogenecity testing, S5 reproductive toxicology ,

EFFICACY:

EFFICACY Efficacy in human beings,clinical trials E6-good clinical practices E-7 clinical trials

MULTIDISCIPLINARY:

MULTIDISCIPLINARY Those that do not uniquely fit into these categories E.g.M1-Medical terminologies M2-electronic standards for submission

Who are the parties in a Clinical Trial?:

Who are the parties in a Clinical Trial? Sponsor Investigator Patient Regulatory Authorities Ethics Committee Clinical Trial

Efficacy Guidelines:

Efficacy Guidelines E1 - Exposure- extent of population exposure to assess clinical safety E2 - Clinical Safety E2A- CSDM – Definitions & Standards for Expedited Reporting E2B- CSDM – Data Elements for transmission of individual safety reports E2C- CSDM- Periodic Safety Update Reports for Marketed Drugs CSDM=Clinical Safety Data Management

Efficacy Guidelines: E3 to E9:

Efficacy Guidelines: E3 to E9 E3 - Structure and Content of Study Reports E4 - Dose-Response Info to Support Drug Registration E5 - Ethnic Factors in Acceptability of Foreign Data E6 - Good Clinical Practice Consolidated Guideline E7 - Studies in Support of Special Pop – Geriatrics E8 - General Considerations for CTs E9 - Statistical Principles for CTs E11 - CTs in Children E10 - Choice of Control Group in CTs E12 - Clinical trials in Antihypertensives

Quality Guidelines: Stability Testing:

Quality Guidelines: Stability Testing Q1A – 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

Quality Guidelines: Analytical Validation:

Quality Guidelines: Analytical Validation Q2A – Text on Validation of Analytical Procedures Q2B – Validation of Analytical Procedures: Methodology

Quality Guidelines: Impurities:

Quality Guidelines: Impurities Q3A – Impurities in New Drug Substances Q3B – Impurities in New Drug Products Q3C – Impurities: Guidelines for Residual Solvents

Quality Guidelines – Biotechnological Quality:

Quality Guidelines – Biotechnological Quality Q5A – Viral Safety Evaluation of Biotechnology Products Q5B – Quality of Biotechnological Products: Analysis of the Expression Constructs in cells used for the production of r-DNA derived protein products Q5C – Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological products Q5D - Quality of Biotechnological Products: Derivation and Characterization of Cell Substrates used for Production of Biotechnological/Biological products

Quality Guidelines – Biotechnological Quality:

Quality Guidelines – Biotechnological Quality Q5A – Viral Safety Evaluation of Biotechnology Products Q5B – Quality of Biotechnological Products: Analysis of the Expression Constructs in cells used for the production of r-DNA derived protein products Q5C – Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological products Q5D - Quality of Biotechnological Products: Derivation and Characterization of Cell Substrates used for Production of Biotechnological/Biological products

Quality Guidelines – Specifications:

Quality Guidelines – Specifications Q6A – Specifications: Test Specifications and Acceptance Criteria for New Drug substances and Products: Chemical Substances Q6B - Specifications: Test Specifications and Acceptance Criteria for Biotechnological/Biological Substances

Good Clinical Practice (GCP):

Good Clinical Practice (GCP) A standard for the design, conduct, performance, monitoring, auditing, recording, analyses , and reporting of clinical trials that provides assurance that the Data and Reported Results are Credible, and Accurate, and that the Rights, Integrity, and Confidentiality of Trial Subjects are Protected = Quality Data = Ethics Quality Data + Ethics = GCPs

GCP: How does it differ?:

GCP: How does it differ? Major point of difference - related disciplines - GLP and GMP the emphasis on ethical requirements in GCP review and approval of clinical studies by IEC/IRBs necessity to obtain informed consent from prospective study sub

Elements of GCPs:

Elements of GCPs IRB Investigator Sponsor Clinical trial protocol and protocol amendment(s) Investigator’s brochure Essential documents The Big Three

Essential Documents:

Essential Documents Study protocol with all amendments Signed consent form for all subjects IRB submission forms/approval memo(s) All versions of consent form Samples of all recruitment advertisements For all investigational drug studies Completed/signed FDA Form 1572 Investigator’s brochure

GCP - Benefits:

GCP - Benefits International acceptance of studies Clarified responsibilities Research is more acceptable to patients, clinicians etc. Avoidance of wasteful research Standardised procedures

Importance of GCP :

Importance of GCP Adherence to internatl ethical & scientific quality standards Provides public assurance that rights, safety & well-being is protected Adds credibility to DATA Ensures acceptance of data by regulatory authorities Importance of GCP Scientific Community Public Regulators DATA

Importance of ICH-GCP guidelines:

Importance of ICH-GCP guidelines Protection of clinical trial subjects Ensuring ‘good’ science Avoiding unethical processes Applicability across geographical locations Ensure ‘quality of care’ Data accuracy and reliability Prevention of data alterations

Importance of ICH-GCP Guidelines:

Importance of ICH-GCP Guidelines Sets a benchmark for global clinical trials Will permit modification of regulatory procedures wherever deficient or inconsistent with ethics & GCP Aimed at improving clinical development process Enhance clinical research capabilities and build capacity

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