SlideShare une entreprise Scribd logo
1  sur  14
Télécharger pour lire hors ligne
QUALITY CONTROL AND QUALITY ASSURANCE
ASSIGNMENT SUBMITTED ON: ICH GUIDELINES
SUBMITTED TO: Dr.M.KRISHNAVENI HOD DEPARTMENT OF
PHARMACEUTICAL ANALYSIS
SUBMITTED BY: SWATHI.P I M.PHARM
PHARMACEUTICAL QUALITY ASSURANCE
SUBMITTED ON: 23/07/2019
ICH GUIDELINES
ICH GUIDELINES
• The International Council for harmonization of Technical
Requirements for Pharmaceuticals for Human Use (ICH).
• It is an initiative that brings together regulatory authorities and
pharmaceutical industries in the scientific and technical discussions
of procedures which are required to ensure safety, quality and
efficacy of medicines.
• The focus of ICH has been on the technical requirements for
medicinal products containing new drugs.
ICH Guidelines are divided into four categories , they are
Q •Stability
•Impurities testing
•GMP
S •Carcinogenicity
•Genotoxicity
•Reprotoxicity
E •Clinical trials
•Pharmacogenomics
M •MedDRA
•CTD
•Electronic Standards
Q S E M
ICH QUALITY GUIDELINES
S.NO Q.NO SUB
DIVISION
NAME OF THE GUIDELINES
1. Q1 Stability A(R2) Stability Testing of new Drug substances and Products
B Stability testing: Photostability Testing of New Drug
Substances and Products
C Stability Testing for New Dosage Forms
D Bracketing and Matrixing Designs for Stability Testing
of New Drug Substances and Products
E Evaluation of Stability Data
F Stability Data Package for Registration Applications in
Climatic Zones III and IV
2. Q2
Analytical
Validation
(R1) Validation of Analytical Procedures: Text and
Methodology
(R2)/Q14 Analytical Procedure Development and Revision of
Q2(R1) Analytical Validation
3. Q3
Impurities
A(R2) Impurities in New Drug Substances
B(R2) Impurities in New Drug Products
C(R7) Impurities: Guideline for Residual Solvents
Multidisciplinary
Guidelines: Cross-
cutting topics which do
not fit uniquely into one
of the Q,S&E. It includes
MedDRA,CTD and the
development of
Electronic Standards for
Transfer of Regulatory
Information(ESTRI).
Safety Guidelines:
Safety Guidelines to
uncover potential risks
like carcinogenicity,
genotoxicity and
reprotoxicity.
Efficacy Guidelines:
The work carried out by
ICH under the Efficacy
heading is concerned
with the design,
conduct , safety and
reporting of clinical
trials.
Quality
Guidelines:Harmonisation
Achievements in the
Quality area including
Stability studies,
impurities testing and a
more flexible approach to
Pharmaceutical quality
based on GMP risk
management.
C(R8) Impurities: Guideline for Residual Solvents
D(R1) Guideline for Elemental Impurities
D(R2) Revision of Q3D(R1) for cutaneous and transdermal
products
D training Implementation of Guideline for Elemental Impurities
4. Q4 Pharmacopoeias
A Pharmacopoeial Harmonization
B Evaluation and Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions
B Annex
1R1
Residue on Ignition/Sulphated ash General Chapter
B Annex
2R1
Test for Extractable Volume of Parenteral Preparations
General Chapter
B Annex
3R1
Test for Particulate Contamination : Sub-Visible
Particles General Chapter
B Annex
4AR1
Microbiological Examination of Non-Sterile Products:
Microbial Enumeration Tests General Chapter
B Annex
4BR1
Microbiological Examination of Non-Sterile Products:
Tests for Specified Micro-organisms General Chapter
B Annex
4CR1
Microbiological Examination of Non-sterile products:
Acceptance criteria for Pharmaceutical Preparations
and Substances for Pharmaceutical Use General
Chapter
B Annex
5R1
Disintegration Test General Chapter
B Annex 6 Uniformity of Dosage Units general Chapter
B Annex
7R2
Dissolution Test General Chapter
B Annex
8R1
Sterility Test General Chapter
B Annex
9R1
Tablet Friability General Chapter
B Annex
10R1
Polyacrylamide Gel Electrophoresis General Chapter
B Annex 11 Capillary Electrophoresis General Chapter
B Annex 12 Analytical Sieving General Chapter
B Annex 13 Bulk Density and Tapped Density of Powders General
Chapter
B Annex 14 Bacterial Endotoxins Test General Chapter
B FAQs Frequently Asked Questions
5. Q5 Quality
of
Biotechnolo
gical
Products
A(R1) Viral Safety Evaluation of Biotechnology Products
Derived from Cell Lines of Human or Animal Origin
B Analysis of the Expression Construct in Cells Used for
Production of r-DNA Derived Protein Products
C Stability Testing of Biotechnological/Biological
Products
D Derivation and Characterization of Cell Substrates
Used for Production of Biotechnological/Biological
Products
E Comparability of Biotechnological/Biological Products
Subject to Changes in their Manufacturing Process
6. Q6
Specification
s
A Specifications : Test Procedures and Acceptance
Criteria for New Drug Substances and New Drug
Products: Chemical Substances
B Specifications : Test Procedures and Acceptance
Criteria for Biotechnological/Biological Products
7. Q7 Good
Manufacturi
ng Practice
Good Manufacturing Practice Guide for Active
Pharmaceutical Ingredients
Q&As Questions and Answers: Good Manufacturing Practice
Guide for Active Pharmaceutical Ingredients
8. Q8
Pharmaceuti
R2 Pharmaceutical Development
cal
Developmen
t
Q8/9/10
Q&AsR4
Q8/Q9/Q10 – Implementation
9. Q9 Quality
Risk
Management
Quality Risk Management
Q8/9/10
Q&AsR4
Q8/Q9/Q10 – Implementation
10. Q10Pharmac
eutical
Quality
System
Pharmaceutical Quality System
11. Q11
Developmen
t and
Manufacture
of Drug
Substances
Development and Manufacture of Drug Substances
(Chemical Entities and Biotechnological/Biological
Entities)
12. Q&As Questions & Answers: Selection and Justification of
Starting Materials for the Manufacture of Drug
Substances
13. Q12
Lifecycle
Management
Technical and Regulatory Considerations for
Pharmaceutical Product Lifecycle Management
14. Q13
Continuous
Manufacturi
ng of Drug
Substances
and Drug
Products
Continuous Manufacturing of Drug Substances and
Drug Products
Q14
Analytical
Procedure
Developmen
Analytical Procedure Development
t
ICH SAFETY GUIDELINES
S.No SAFETY
NO
SUB
DIBISION
NAME OF THE GUIDELINE
1. S1
Carcinogeni
city studies
R1 Rodent Carcinogenicity Studies for Human
Pharmaceuticals
A Need for Carcinogenicity Studies of
Pharmaceuticals
B S1B
Testing for Carcinogenicity of Pharmaceuticals
C(R2) Dose Selection for Carcinogenicity Studies of
Pharmaceuticals
2. S2
Genotoxicity
studies
(R1) Guidance on Genotoxicity Testing and Data
Interpretation for Pharmaceuticals Intended for
Human Use
3. S3
Toxicokineti
cs and
Pharmacoki
netics
A Note for Guidance on Toxicokinetics: The
Assessment of Systemic Exposure in Toxicity
Studies
A Q&As Questions and Answers: Note for Guidance on
Toxicokinetics: The Assessment of Systemic
Exposure - Focus on Microsampling
B Pharmacokinetics: Guidance for Repeated Dose
Tissue Distribution Studies
4. S4 Toxicity
testing
Duration of Chronic Toxicity Testing in Animals
(Rodent and Non Rodent Toxicity Testing)
5. S5
Reproductiv
(R2) Detection of Toxicity to Reproduction for
Medicinal Products & Toxicity to Male Fertility
e
Toxicology
(R3) Revision of S5 Guideline on Detection of Toxicity
to Reproduction for Human Pharmaceuticals
6. S6
Biotechnolo
gical
Products
(R1) Preclinical Safety Evaluation of Biotechnology-
Derived Pharmaceuticals
7. S7
Pharmacolo
gical studies
A Safety Pharmacology Studies for Human
Pharmaceuticals
B The Non-Clinical Evaluation of the Potential for
Delayed Ventricular Repolarization (QT Interval
Prolongation) by Human Pharmaceuticals
E14/S7BQ&
As
E14/S7B Q&As
Questions & Answers: Clinical and non-Clinical
Evaluation of QT/QTc Interval Prolongation and
Proarrhythmic Potential
8. S8
Immunotoxi
cology
studies
Immunotoxicity Studies for Human
Pharmaceuticals
9. S9
Nonclinical
Evaluation
for
Anticancer
Pharmaceuti
cals
Nonclinical Evaluation for Anticancer
Pharmaceuticals
Q&As Questions and Answers: Nonclinical Evaluation for
Anticancer Pharmaceuticals
10. S10
Photosafety
Evaluation
Photosafety Evaluation of Pharmaceuticals
11. S11 Non-
clinical
Nonclinical Safety Testing in Support of
Development of Paediatric Medicines
paediatric
safety
ICH EFFICACY GUIDELINES
S.No EFFICACY
NO
SUB
DIVISION
NAME OF THE GUIDELINE
1. E1 Clinical
Safety for
Drugs Used
in Long-
Term
Treatment
The Extent of Population Exposure to Assess
Clinical Safety for Drugs Intended for Long-Term
Treatment of Non-Life Threatening Conditions
2. E2
Pharmacovi
gilance
A Clinical Safety Data Management: Definitions and
Standards for Expedited Reporting
B(R3) Clinical Safety Data Management: Data Elements
for Transmission of Individual Case Safety Reports
B(R3) Q&As Implementation: Electronic Transmission of
Individual Case Safety Reports
C (R2) Periodic Benefit-Risk Evaluation Report
C(R2) Q&As Questions & Answers: Periodic Benefit-Risk
Evaluation Report
D Post-Approval Safety Data Management:
Definitions and Standards for Expedited Reporting
E Pharmacovigilance Planning
F Development Safety Update Report
3. E3 Clinical
Study
Structure and Content of Clinical Study Reports
Reports
Q&As (R1) Questions & Answers: Structure and Content of
Clinical Study Reports
4. E4 Dose
Response
Studies
Dose-Response Information to Support Drug
Registration
5. E5 Ethnic
factors
(R1) Ethnic Factors in the Acceptability of Foreign
Clinical Data
Q&As (R1) Questions & Answers: Ethnic Factors in the
Acceptability of Foreign Clinical Data
6. E6 (R2) Good Clinical Practice (GCP)
7. E7 Clinical
Trials in
Geriatric
Population
Studies in Support of Special Populations:
Geriatrics
Q&As Questions & Answers: Studies in Support of
Special Populations : Geriatrics
8. E8 General
Considerati
ons for
Clinical
Trials
General Considerations for Clinical Trials
(R1) Revision on General Considerations for Clinical
Trials
9. E9
Statistical
Principles
for Clinical
Trials
Statistical Principles for Clinical Trials
(R1) Addendum: Statistical Principles for Clinical
Trials
10. E10 Choice
of Control
Group in
Choice of Control Group and Related Issues in
Clinical Trials
Clinical
Trials
11. E11
Clinical
Trials in
Paediatric
Population
(R1) Addendum: Clinical Investigation of Medicinal
Products in the Paediatric Population
A Paediatric Extrapolation
12. E12
Clinical
Evaluation
by
Therapeutic
Category
Principles for Clinical Evaluation of New
Antihypertensive Drugs
13. E14
Clinical
Evaluation
of QT
The Clinical Evaluation of QT/QTc Interval
Prolongation and Proarrhythmic Potential for
Non-Antiarrhythmic Drugs
Q&As(R3) Questions & Answers: The Clinical Evaluation of
QT/QTc Interval Prolongation and Proarrhythmic
Potential for Non-Antiarrhythmic Drugs
E14/S7B
Q&As
Questions & Answers: Clinical and non-Clinical
Evaluation of QT/QTc Interval Prolongation and
Proarrhythmic Potential
14. E15
Definitions
in
Pharmacog
enetics/Pha
rmacogeno
mics
Definitions for Genomic Biomarkers,
Pharmacogenomics, Pharmacogenetics, Genomic
Data and Sample Coding Categories
15. E16
Qualificatio
n of
Genomic
Biomarkers
Biomarkers Related to Drug or Biotechnology
Product Development: Context, Structure and
Format of Qualification Submissions
16. E17 Multi-
Regional
General principles for planning and design of
Multi-Regional Clinical Trials
Clinical
Trials
Training General principles for planning and design of
Multi-Regional Clinical Trials
17. E18
Genomic
Sampling
Genomic Sampling and Management of Genomic
Data
18. E19 Safety
Data
Collection
Optimization of Safety Data Collection
19. E20
Adaptive
clinical
Trials
Adaptive Clinical Trials
ICH MULTIDISCIPLINARY GUIDELINES
S.NO MULTIDIS
CIPLINAR
Y NO
SUB
DIVISION
NAME OF THE GUIDELINE
1. M1 MedRA
Terminolog
y
Medical Dictionary for Regulatory Activities
2. M2
Electronic
Standards
ESTRI Electronic Standards for the Transfer of
Regulatory Information
3. M3
Nonclinical
Safety
Studies
(R2) Guidance on Nonclinical Safety Studies for the
Conduct of Human Clinical Trials and Marketing
Authorization for Pharmaceuticals
(R2) Q&As
R2
Questions & Answers: Guidance on Non-Clinical
Safety Studies for the Conduct of Human Clinical
Trials and Marketing Authorization for
Pharmaceuticals
4. M4
Common
Technical
Document
CTD The Common Technical Document
5. M5
Data
Elements
and
Standards
for Drug
Dictionaries
Data Elements and Standards for Drug
Dictionaries
6. M6 Gene
Therapy
Virus and Gene Therapy Vector Shedding and
Transmission
7. M7
Mutagenic
Impurities
(R1) Assessment and Control of DNA Reactive
(Mutagenic) Impurities in Pharmaceuticals to
Limit Potential Carcinogenic Risk
(R2) Assessment and Control of DNA Reactive
(Mutagenic) Impurities in Pharmaceuticals to
Limit Potential Carcinogenic Risk
8. M8
Electronic
Common
Technical
Document
(eCTD)
Electronic Common Technical Document (eCTD)
9. M9
Biopharmac
eutics
Classificatio
n System-
based
Biowaivers
Biopharmaceutics Classification System-based
Biowaivers
10. M10
Bioanalytic
al Method
Validation
Bioanalytical Method Validation
11. M11
Clinical
electronic
Structured
Harmonized
Protocol
(CeSHarP)
Clinical electronic Structured Harmonized
Protocol (CeSHarP)
12. M12
Drug
Interaction
Studies
Drug Interaction Studies

Contenu connexe

Tendances

Quality risk management
Quality risk managementQuality risk management
Quality risk managementimran bakshi
 
Documentation in pharmaceutical industry
Documentation in pharmaceutical industryDocumentation in pharmaceutical industry
Documentation in pharmaceutical industryDevipriya Viswambharan
 
validation of dosage forms
validation of dosage formsvalidation of dosage forms
validation of dosage formsTejaswi Reddy
 
Current Good Manufacturing Practices(cGMP) and industrial management
Current Good Manufacturing Practices(cGMP) and industrial managementCurrent Good Manufacturing Practices(cGMP) and industrial management
Current Good Manufacturing Practices(cGMP) and industrial managementMahewash Sana Pathan
 
CLINICAL TRAIL (TRIAL PROTOCOL & INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHI...
CLINICAL TRAIL (TRIAL PROTOCOL & INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHI...CLINICAL TRAIL (TRIAL PROTOCOL & INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHI...
CLINICAL TRAIL (TRIAL PROTOCOL & INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHI...amitsoni240
 
NDA and ANDA regulatory approval process
NDA and ANDA regulatory approval processNDA and ANDA regulatory approval process
NDA and ANDA regulatory approval processJagrutiKale1
 
DMF Drug Master File
DMF   Drug Master FileDMF   Drug Master File
DMF Drug Master FileRushi Mendhe
 
Out of specification shravan
Out of specification shravanOut of specification shravan
Out of specification shravanshravan dubey
 
Regulatory requirements for api registration
Regulatory requirements for api registrationRegulatory requirements for api registration
Regulatory requirements for api registrationRiyaRYadav
 
Quality target product profile (QTPP)
Quality target product profile (QTPP)Quality target product profile (QTPP)
Quality target product profile (QTPP)Priyesh singh
 
Scale up and post approval changes(supac)
Scale up and post approval changes(supac)Scale up and post approval changes(supac)
Scale up and post approval changes(supac)bdvfgbdhg
 
Validation Of Solid Dosage Forms.
Validation Of Solid Dosage Forms.Validation Of Solid Dosage Forms.
Validation Of Solid Dosage Forms.Ramya priya
 
Pharmaceutical Quality by Design (QBD)
Pharmaceutical Quality by Design (QBD)Pharmaceutical Quality by Design (QBD)
Pharmaceutical Quality by Design (QBD)Kushal Saha
 
Drug product performance , in vivo: bioavailability and bioequivalence
Drug product performance , in vivo: bioavailability and bioequivalenceDrug product performance , in vivo: bioavailability and bioequivalence
Drug product performance , in vivo: bioavailability and bioequivalenceDipakKumarGupta3
 
Validation of dissolution apparatus
Validation of dissolution apparatusValidation of dissolution apparatus
Validation of dissolution apparatusShraddha Kumbhar
 
Validation, scope of validation, URS , WHO GUIDELINES FOR VALIDATION
Validation, scope of validation, URS , WHO GUIDELINES FOR VALIDATIONValidation, scope of validation, URS , WHO GUIDELINES FOR VALIDATION
Validation, scope of validation, URS , WHO GUIDELINES FOR VALIDATIONManikant Prasad Shah
 

Tendances (20)

Master formula record
Master formula recordMaster formula record
Master formula record
 
Quality risk management
Quality risk managementQuality risk management
Quality risk management
 
Documentation in pharmaceutical industry
Documentation in pharmaceutical industryDocumentation in pharmaceutical industry
Documentation in pharmaceutical industry
 
validation of dosage forms
validation of dosage formsvalidation of dosage forms
validation of dosage forms
 
Current Good Manufacturing Practices(cGMP) and industrial management
Current Good Manufacturing Practices(cGMP) and industrial managementCurrent Good Manufacturing Practices(cGMP) and industrial management
Current Good Manufacturing Practices(cGMP) and industrial management
 
CLINICAL TRAIL (TRIAL PROTOCOL & INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHI...
CLINICAL TRAIL (TRIAL PROTOCOL & INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHI...CLINICAL TRAIL (TRIAL PROTOCOL & INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHI...
CLINICAL TRAIL (TRIAL PROTOCOL & INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHI...
 
NDA and ANDA regulatory approval process
NDA and ANDA regulatory approval processNDA and ANDA regulatory approval process
NDA and ANDA regulatory approval process
 
DMF Drug Master File
DMF   Drug Master FileDMF   Drug Master File
DMF Drug Master File
 
Out of specification shravan
Out of specification shravanOut of specification shravan
Out of specification shravan
 
Regulatory requirements for api registration
Regulatory requirements for api registrationRegulatory requirements for api registration
Regulatory requirements for api registration
 
Quality target product profile (QTPP)
Quality target product profile (QTPP)Quality target product profile (QTPP)
Quality target product profile (QTPP)
 
Scale up and post approval changes(supac)
Scale up and post approval changes(supac)Scale up and post approval changes(supac)
Scale up and post approval changes(supac)
 
Validation master plan
Validation master planValidation master plan
Validation master plan
 
Documentation in Pharmaceutical Industry
Documentation in Pharmaceutical IndustryDocumentation in Pharmaceutical Industry
Documentation in Pharmaceutical Industry
 
Validation Of Solid Dosage Forms.
Validation Of Solid Dosage Forms.Validation Of Solid Dosage Forms.
Validation Of Solid Dosage Forms.
 
Pilot plantscaleupof parentrals
Pilot plantscaleupof parentralsPilot plantscaleupof parentrals
Pilot plantscaleupof parentrals
 
Pharmaceutical Quality by Design (QBD)
Pharmaceutical Quality by Design (QBD)Pharmaceutical Quality by Design (QBD)
Pharmaceutical Quality by Design (QBD)
 
Drug product performance , in vivo: bioavailability and bioequivalence
Drug product performance , in vivo: bioavailability and bioequivalenceDrug product performance , in vivo: bioavailability and bioequivalence
Drug product performance , in vivo: bioavailability and bioequivalence
 
Validation of dissolution apparatus
Validation of dissolution apparatusValidation of dissolution apparatus
Validation of dissolution apparatus
 
Validation, scope of validation, URS , WHO GUIDELINES FOR VALIDATION
Validation, scope of validation, URS , WHO GUIDELINES FOR VALIDATIONValidation, scope of validation, URS , WHO GUIDELINES FOR VALIDATION
Validation, scope of validation, URS , WHO GUIDELINES FOR VALIDATION
 

Similaire à ICH GUIDELINES QSEM

Similaire à ICH GUIDELINES QSEM (20)

ICH Guidlines Overview.pptx
ICH Guidlines Overview.pptxICH Guidlines Overview.pptx
ICH Guidlines Overview.pptx
 
ICH guidelines Q & S .pptx
ICH guidelines Q & S .pptxICH guidelines Q & S .pptx
ICH guidelines Q & S .pptx
 
ICH Guidelines
ICH Guidelines ICH Guidelines
ICH Guidelines
 
Ich – quality guidelines
Ich – quality guidelinesIch – quality guidelines
Ich – quality guidelines
 
ICH guideline.pdf
ICH guideline.pdfICH guideline.pdf
ICH guideline.pdf
 
Ich Guidelines Au. Vivek Jain
Ich Guidelines Au. Vivek JainIch Guidelines Au. Vivek Jain
Ich Guidelines Au. Vivek Jain
 
ICH guidelines
ICH guidelinesICH guidelines
ICH guidelines
 
Ich
IchIch
Ich
 
ICH guidelines (Q,S,E,M)
ICH guidelines (Q,S,E,M)ICH guidelines (Q,S,E,M)
ICH guidelines (Q,S,E,M)
 
ICH QSEM Guidelines
ICH QSEM GuidelinesICH QSEM Guidelines
ICH QSEM Guidelines
 
ICH - quality guidelines
ICH - quality guidelinesICH - quality guidelines
ICH - quality guidelines
 
Quality management systems qms tqm
Quality management systems qms tqmQuality management systems qms tqm
Quality management systems qms tqm
 
ich ppt ok tested.pptxaaaaàaaaaaaaaaaaaa
ich ppt ok tested.pptxaaaaàaaaaaaaaaaaaaich ppt ok tested.pptxaaaaàaaaaaaaaaaaaa
ich ppt ok tested.pptxaaaaàaaaaaaaaaaaaa
 
1.3 ICH .pdf
1.3 ICH .pdf1.3 ICH .pdf
1.3 ICH .pdf
 
overview of ich guidelines
overview of ich guidelines overview of ich guidelines
overview of ich guidelines
 
ICH.pptx
ICH.pptxICH.pptx
ICH.pptx
 
Pharmaceutical Guidelines
Pharmaceutical GuidelinesPharmaceutical Guidelines
Pharmaceutical Guidelines
 
ICH
ICHICH
ICH
 
ICH GUIDELINES of chemical engineering (2).pdf
ICH GUIDELINES of chemical engineering (2).pdfICH GUIDELINES of chemical engineering (2).pdf
ICH GUIDELINES of chemical engineering (2).pdf
 
Ich guidelines with all process ,members, objectives
Ich guidelines with all process ,members, objectivesIch guidelines with all process ,members, objectives
Ich guidelines with all process ,members, objectives
 

Dernier

MedMatch: Your Health, Our Mission. Pitch deck.
MedMatch: Your Health, Our Mission. Pitch deck.MedMatch: Your Health, Our Mission. Pitch deck.
MedMatch: Your Health, Our Mission. Pitch deck.whalesdesign
 
Generative AI in Health Care a scoping review and a persoanl experience.
Generative AI in Health Care a scoping review and a persoanl experience.Generative AI in Health Care a scoping review and a persoanl experience.
Generative AI in Health Care a scoping review and a persoanl experience.Vaikunthan Rajaratnam
 
Adenomyosis or Fibroid- making right diagnosis
Adenomyosis or Fibroid- making right diagnosisAdenomyosis or Fibroid- making right diagnosis
Adenomyosis or Fibroid- making right diagnosisSujoy Dasgupta
 
Mental health Team. Dr Senthil Thirusangu
Mental health Team. Dr Senthil ThirusanguMental health Team. Dr Senthil Thirusangu
Mental health Team. Dr Senthil Thirusangu Medical University
 
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptxANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptxWINCY THIRUMURUGAN
 
"Radical excision of DIE in subferile women with deep infiltrating endometrio...
"Radical excision of DIE in subferile women with deep infiltrating endometrio..."Radical excision of DIE in subferile women with deep infiltrating endometrio...
"Radical excision of DIE in subferile women with deep infiltrating endometrio...Sujoy Dasgupta
 
Breast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptx
Breast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptxBreast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptx
Breast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptxNaveenkumar267201
 
Using Data Visualization in Public Health Communications
Using Data Visualization in Public Health CommunicationsUsing Data Visualization in Public Health Communications
Using Data Visualization in Public Health Communicationskatiequigley33
 
Male Infertility Panel Discussion by Dr Sujoy Dasgupta
Male Infertility Panel Discussion by Dr Sujoy DasguptaMale Infertility Panel Discussion by Dr Sujoy Dasgupta
Male Infertility Panel Discussion by Dr Sujoy DasguptaSujoy Dasgupta
 
AUTONOMIC NERVOUS SYSTEM organization and functions
AUTONOMIC NERVOUS SYSTEM organization and functionsAUTONOMIC NERVOUS SYSTEM organization and functions
AUTONOMIC NERVOUS SYSTEM organization and functionsMedicoseAcademics
 
Pharmacokinetic Models by Dr. Ram D. Bawankar.ppt
Pharmacokinetic Models by Dr. Ram D.  Bawankar.pptPharmacokinetic Models by Dr. Ram D.  Bawankar.ppt
Pharmacokinetic Models by Dr. Ram D. Bawankar.pptRamDBawankar1
 
Physiology of Smooth Muscles -Mechanics of contraction and relaxation
Physiology of Smooth Muscles -Mechanics of contraction and relaxationPhysiology of Smooth Muscles -Mechanics of contraction and relaxation
Physiology of Smooth Muscles -Mechanics of contraction and relaxationMedicoseAcademics
 
SGK ĐIỆN GIẬT ĐHYHN RẤT LÀ HAY TUYỆT VỜI.pdf
SGK ĐIỆN GIẬT ĐHYHN        RẤT LÀ HAY TUYỆT VỜI.pdfSGK ĐIỆN GIẬT ĐHYHN        RẤT LÀ HAY TUYỆT VỜI.pdf
SGK ĐIỆN GIẬT ĐHYHN RẤT LÀ HAY TUYỆT VỜI.pdfHongBiThi1
 
Male Infertility, Antioxidants and Beyond
Male Infertility, Antioxidants and BeyondMale Infertility, Antioxidants and Beyond
Male Infertility, Antioxidants and BeyondSujoy Dasgupta
 
power point presentation of Clinical evaluation of strabismus
power point presentation of Clinical evaluation  of strabismuspower point presentation of Clinical evaluation  of strabismus
power point presentation of Clinical evaluation of strabismusChandrasekar Reddy
 
EXERCISE PERFORMANCE.pptx, Lung function
EXERCISE PERFORMANCE.pptx, Lung functionEXERCISE PERFORMANCE.pptx, Lung function
EXERCISE PERFORMANCE.pptx, Lung functionkrishnareddy157915
 
SGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA .pdf
SGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA    .pdfSGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA    .pdf
SGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA .pdfHongBiThi1
 
pA2 value, Schild plot and pD2 values- applications in pharmacology
pA2 value, Schild plot and pD2 values- applications in pharmacologypA2 value, Schild plot and pD2 values- applications in pharmacology
pA2 value, Schild plot and pD2 values- applications in pharmacologyDeepakDaniel9
 

Dernier (20)

MedMatch: Your Health, Our Mission. Pitch deck.
MedMatch: Your Health, Our Mission. Pitch deck.MedMatch: Your Health, Our Mission. Pitch deck.
MedMatch: Your Health, Our Mission. Pitch deck.
 
Generative AI in Health Care a scoping review and a persoanl experience.
Generative AI in Health Care a scoping review and a persoanl experience.Generative AI in Health Care a scoping review and a persoanl experience.
Generative AI in Health Care a scoping review and a persoanl experience.
 
Adenomyosis or Fibroid- making right diagnosis
Adenomyosis or Fibroid- making right diagnosisAdenomyosis or Fibroid- making right diagnosis
Adenomyosis or Fibroid- making right diagnosis
 
Mental health Team. Dr Senthil Thirusangu
Mental health Team. Dr Senthil ThirusanguMental health Team. Dr Senthil Thirusangu
Mental health Team. Dr Senthil Thirusangu
 
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptxANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptx
 
Immune labs basics part 1 acute phase reactants ESR, CRP Ahmed Yehia Ismaeel,...
Immune labs basics part 1 acute phase reactants ESR, CRP Ahmed Yehia Ismaeel,...Immune labs basics part 1 acute phase reactants ESR, CRP Ahmed Yehia Ismaeel,...
Immune labs basics part 1 acute phase reactants ESR, CRP Ahmed Yehia Ismaeel,...
 
"Radical excision of DIE in subferile women with deep infiltrating endometrio...
"Radical excision of DIE in subferile women with deep infiltrating endometrio..."Radical excision of DIE in subferile women with deep infiltrating endometrio...
"Radical excision of DIE in subferile women with deep infiltrating endometrio...
 
Breast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptx
Breast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptxBreast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptx
Breast cancer -ONCO IN MEDICAL AND SURGICAL NURSING.pptx
 
Using Data Visualization in Public Health Communications
Using Data Visualization in Public Health CommunicationsUsing Data Visualization in Public Health Communications
Using Data Visualization in Public Health Communications
 
Male Infertility Panel Discussion by Dr Sujoy Dasgupta
Male Infertility Panel Discussion by Dr Sujoy DasguptaMale Infertility Panel Discussion by Dr Sujoy Dasgupta
Male Infertility Panel Discussion by Dr Sujoy Dasgupta
 
AUTONOMIC NERVOUS SYSTEM organization and functions
AUTONOMIC NERVOUS SYSTEM organization and functionsAUTONOMIC NERVOUS SYSTEM organization and functions
AUTONOMIC NERVOUS SYSTEM organization and functions
 
Pharmacokinetic Models by Dr. Ram D. Bawankar.ppt
Pharmacokinetic Models by Dr. Ram D.  Bawankar.pptPharmacokinetic Models by Dr. Ram D.  Bawankar.ppt
Pharmacokinetic Models by Dr. Ram D. Bawankar.ppt
 
Physiology of Smooth Muscles -Mechanics of contraction and relaxation
Physiology of Smooth Muscles -Mechanics of contraction and relaxationPhysiology of Smooth Muscles -Mechanics of contraction and relaxation
Physiology of Smooth Muscles -Mechanics of contraction and relaxation
 
SGK ĐIỆN GIẬT ĐHYHN RẤT LÀ HAY TUYỆT VỜI.pdf
SGK ĐIỆN GIẬT ĐHYHN        RẤT LÀ HAY TUYỆT VỜI.pdfSGK ĐIỆN GIẬT ĐHYHN        RẤT LÀ HAY TUYỆT VỜI.pdf
SGK ĐIỆN GIẬT ĐHYHN RẤT LÀ HAY TUYỆT VỜI.pdf
 
Male Infertility, Antioxidants and Beyond
Male Infertility, Antioxidants and BeyondMale Infertility, Antioxidants and Beyond
Male Infertility, Antioxidants and Beyond
 
power point presentation of Clinical evaluation of strabismus
power point presentation of Clinical evaluation  of strabismuspower point presentation of Clinical evaluation  of strabismus
power point presentation of Clinical evaluation of strabismus
 
EXERCISE PERFORMANCE.pptx, Lung function
EXERCISE PERFORMANCE.pptx, Lung functionEXERCISE PERFORMANCE.pptx, Lung function
EXERCISE PERFORMANCE.pptx, Lung function
 
How to master Steroid (glucocorticoids) prescription, different scenarios, ca...
How to master Steroid (glucocorticoids) prescription, different scenarios, ca...How to master Steroid (glucocorticoids) prescription, different scenarios, ca...
How to master Steroid (glucocorticoids) prescription, different scenarios, ca...
 
SGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA .pdf
SGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA    .pdfSGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA    .pdf
SGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA .pdf
 
pA2 value, Schild plot and pD2 values- applications in pharmacology
pA2 value, Schild plot and pD2 values- applications in pharmacologypA2 value, Schild plot and pD2 values- applications in pharmacology
pA2 value, Schild plot and pD2 values- applications in pharmacology
 

ICH GUIDELINES QSEM

  • 1. QUALITY CONTROL AND QUALITY ASSURANCE ASSIGNMENT SUBMITTED ON: ICH GUIDELINES SUBMITTED TO: Dr.M.KRISHNAVENI HOD DEPARTMENT OF PHARMACEUTICAL ANALYSIS SUBMITTED BY: SWATHI.P I M.PHARM PHARMACEUTICAL QUALITY ASSURANCE SUBMITTED ON: 23/07/2019
  • 2. ICH GUIDELINES ICH GUIDELINES • The International Council for harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). • It is an initiative that brings together regulatory authorities and pharmaceutical industries in the scientific and technical discussions of procedures which are required to ensure safety, quality and efficacy of medicines. • The focus of ICH has been on the technical requirements for medicinal products containing new drugs. ICH Guidelines are divided into four categories , they are Q •Stability •Impurities testing •GMP S •Carcinogenicity •Genotoxicity •Reprotoxicity E •Clinical trials •Pharmacogenomics M •MedDRA •CTD •Electronic Standards
  • 3. Q S E M ICH QUALITY GUIDELINES S.NO Q.NO SUB DIVISION NAME OF THE GUIDELINES 1. Q1 Stability A(R2) Stability Testing of new Drug substances and Products B Stability testing: Photostability Testing of New Drug Substances and Products C Stability Testing for New Dosage Forms D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products E Evaluation of Stability Data F Stability Data Package for Registration Applications in Climatic Zones III and IV 2. Q2 Analytical Validation (R1) Validation of Analytical Procedures: Text and Methodology (R2)/Q14 Analytical Procedure Development and Revision of Q2(R1) Analytical Validation 3. Q3 Impurities A(R2) Impurities in New Drug Substances B(R2) Impurities in New Drug Products C(R7) Impurities: Guideline for Residual Solvents Multidisciplinary Guidelines: Cross- cutting topics which do not fit uniquely into one of the Q,S&E. It includes MedDRA,CTD and the development of Electronic Standards for Transfer of Regulatory Information(ESTRI). Safety Guidelines: Safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. Efficacy Guidelines: The work carried out by ICH under the Efficacy heading is concerned with the design, conduct , safety and reporting of clinical trials. Quality Guidelines:Harmonisation Achievements in the Quality area including Stability studies, impurities testing and a more flexible approach to Pharmaceutical quality based on GMP risk management.
  • 4. C(R8) Impurities: Guideline for Residual Solvents D(R1) Guideline for Elemental Impurities D(R2) Revision of Q3D(R1) for cutaneous and transdermal products D training Implementation of Guideline for Elemental Impurities 4. Q4 Pharmacopoeias A Pharmacopoeial Harmonization B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions B Annex 1R1 Residue on Ignition/Sulphated ash General Chapter B Annex 2R1 Test for Extractable Volume of Parenteral Preparations General Chapter B Annex 3R1 Test for Particulate Contamination : Sub-Visible Particles General Chapter B Annex 4AR1 Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter B Annex 4BR1 Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter B Annex 4CR1 Microbiological Examination of Non-sterile products: Acceptance criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter B Annex 5R1 Disintegration Test General Chapter B Annex 6 Uniformity of Dosage Units general Chapter B Annex 7R2 Dissolution Test General Chapter B Annex 8R1 Sterility Test General Chapter B Annex 9R1 Tablet Friability General Chapter
  • 5. B Annex 10R1 Polyacrylamide Gel Electrophoresis General Chapter B Annex 11 Capillary Electrophoresis General Chapter B Annex 12 Analytical Sieving General Chapter B Annex 13 Bulk Density and Tapped Density of Powders General Chapter B Annex 14 Bacterial Endotoxins Test General Chapter B FAQs Frequently Asked Questions 5. Q5 Quality of Biotechnolo gical Products A(R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin B Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products C Stability Testing of Biotechnological/Biological Products D Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products E Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process 6. Q6 Specification s A Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances B Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products 7. Q7 Good Manufacturi ng Practice Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q&As Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 8. Q8 Pharmaceuti R2 Pharmaceutical Development
  • 6. cal Developmen t Q8/9/10 Q&AsR4 Q8/Q9/Q10 – Implementation 9. Q9 Quality Risk Management Quality Risk Management Q8/9/10 Q&AsR4 Q8/Q9/Q10 – Implementation 10. Q10Pharmac eutical Quality System Pharmaceutical Quality System 11. Q11 Developmen t and Manufacture of Drug Substances Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) 12. Q&As Questions & Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances 13. Q12 Lifecycle Management Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management 14. Q13 Continuous Manufacturi ng of Drug Substances and Drug Products Continuous Manufacturing of Drug Substances and Drug Products Q14 Analytical Procedure Developmen Analytical Procedure Development
  • 7. t ICH SAFETY GUIDELINES S.No SAFETY NO SUB DIBISION NAME OF THE GUIDELINE 1. S1 Carcinogeni city studies R1 Rodent Carcinogenicity Studies for Human Pharmaceuticals A Need for Carcinogenicity Studies of Pharmaceuticals B S1B Testing for Carcinogenicity of Pharmaceuticals C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals 2. S2 Genotoxicity studies (R1) Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use 3. S3 Toxicokineti cs and Pharmacoki netics A Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies A Q&As Questions and Answers: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure - Focus on Microsampling B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies 4. S4 Toxicity testing Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing) 5. S5 Reproductiv (R2) Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility
  • 8. e Toxicology (R3) Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals 6. S6 Biotechnolo gical Products (R1) Preclinical Safety Evaluation of Biotechnology- Derived Pharmaceuticals 7. S7 Pharmacolo gical studies A Safety Pharmacology Studies for Human Pharmaceuticals B The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals E14/S7BQ& As E14/S7B Q&As Questions & Answers: Clinical and non-Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential 8. S8 Immunotoxi cology studies Immunotoxicity Studies for Human Pharmaceuticals 9. S9 Nonclinical Evaluation for Anticancer Pharmaceuti cals Nonclinical Evaluation for Anticancer Pharmaceuticals Q&As Questions and Answers: Nonclinical Evaluation for Anticancer Pharmaceuticals 10. S10 Photosafety Evaluation Photosafety Evaluation of Pharmaceuticals 11. S11 Non- clinical Nonclinical Safety Testing in Support of Development of Paediatric Medicines
  • 9. paediatric safety ICH EFFICACY GUIDELINES S.No EFFICACY NO SUB DIVISION NAME OF THE GUIDELINE 1. E1 Clinical Safety for Drugs Used in Long- Term Treatment The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions 2. E2 Pharmacovi gilance A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting B(R3) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports B(R3) Q&As Implementation: Electronic Transmission of Individual Case Safety Reports C (R2) Periodic Benefit-Risk Evaluation Report C(R2) Q&As Questions & Answers: Periodic Benefit-Risk Evaluation Report D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting E Pharmacovigilance Planning F Development Safety Update Report 3. E3 Clinical Study Structure and Content of Clinical Study Reports
  • 10. Reports Q&As (R1) Questions & Answers: Structure and Content of Clinical Study Reports 4. E4 Dose Response Studies Dose-Response Information to Support Drug Registration 5. E5 Ethnic factors (R1) Ethnic Factors in the Acceptability of Foreign Clinical Data Q&As (R1) Questions & Answers: Ethnic Factors in the Acceptability of Foreign Clinical Data 6. E6 (R2) Good Clinical Practice (GCP) 7. E7 Clinical Trials in Geriatric Population Studies in Support of Special Populations: Geriatrics Q&As Questions & Answers: Studies in Support of Special Populations : Geriatrics 8. E8 General Considerati ons for Clinical Trials General Considerations for Clinical Trials (R1) Revision on General Considerations for Clinical Trials 9. E9 Statistical Principles for Clinical Trials Statistical Principles for Clinical Trials (R1) Addendum: Statistical Principles for Clinical Trials 10. E10 Choice of Control Group in Choice of Control Group and Related Issues in Clinical Trials
  • 11. Clinical Trials 11. E11 Clinical Trials in Paediatric Population (R1) Addendum: Clinical Investigation of Medicinal Products in the Paediatric Population A Paediatric Extrapolation 12. E12 Clinical Evaluation by Therapeutic Category Principles for Clinical Evaluation of New Antihypertensive Drugs 13. E14 Clinical Evaluation of QT The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Q&As(R3) Questions & Answers: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs E14/S7B Q&As Questions & Answers: Clinical and non-Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential 14. E15 Definitions in Pharmacog enetics/Pha rmacogeno mics Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories 15. E16 Qualificatio n of Genomic Biomarkers Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions 16. E17 Multi- Regional General principles for planning and design of Multi-Regional Clinical Trials
  • 12. Clinical Trials Training General principles for planning and design of Multi-Regional Clinical Trials 17. E18 Genomic Sampling Genomic Sampling and Management of Genomic Data 18. E19 Safety Data Collection Optimization of Safety Data Collection 19. E20 Adaptive clinical Trials Adaptive Clinical Trials ICH MULTIDISCIPLINARY GUIDELINES S.NO MULTIDIS CIPLINAR Y NO SUB DIVISION NAME OF THE GUIDELINE 1. M1 MedRA Terminolog y Medical Dictionary for Regulatory Activities 2. M2 Electronic Standards ESTRI Electronic Standards for the Transfer of Regulatory Information 3. M3 Nonclinical Safety Studies (R2) Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (R2) Q&As R2 Questions & Answers: Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals 4. M4 Common Technical Document CTD The Common Technical Document
  • 13. 5. M5 Data Elements and Standards for Drug Dictionaries Data Elements and Standards for Drug Dictionaries 6. M6 Gene Therapy Virus and Gene Therapy Vector Shedding and Transmission 7. M7 Mutagenic Impurities (R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk (R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk 8. M8 Electronic Common Technical Document (eCTD) Electronic Common Technical Document (eCTD) 9. M9 Biopharmac eutics Classificatio n System- based Biowaivers Biopharmaceutics Classification System-based Biowaivers 10. M10 Bioanalytic al Method Validation Bioanalytical Method Validation 11. M11 Clinical electronic Structured Harmonized Protocol (CeSHarP) Clinical electronic Structured Harmonized Protocol (CeSHarP)