Ich ppt

Presented by-

Mukul Sunil Tambe.

M. Pharm Sem. II

Pharmacology

Roll no. 8Tuesday, October 10, 2017 1

CONTENTS:1. • INTRODUCTION

2. •HARMONIZATION EFFORTS

3. •BASIC PRINCIPLES

4. •Q 11 GUIDELINE

5. •CTD

6. •REFERENCES2Tuesday, October 10, 2017

INTRODUCTIONInternational Conference on Harmonization of

Technical Requirements for Registration of Pharmaceuticals for Human Use.

Agreement between Europe, Japan and US regulatory Authorities.

Joint initiative involving both Regulators and Industry as equal partners.

Main focus on Technical Requirements for medicinal products containing new drugs.

Tuesday, October 10, 2017 3Ref.: Forensic Pharmacy by B.S. Kuchekar

Pg. No. 16.16 – 16.25

Establishment of ICH

• The International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) was established in 1990 as a tripartite venture representing regulatory bodies and research-based industry.Tuesday, October 10, 2017 4

Ref.: http://apps.who.int/medicinedocs/en/d

/Jh2993e/4.html

INTRODUCTION (Contd.)Achieve greater harmonization

in interpretation and

application of Technical

guidelines.

More economical use of

Human, Animal and Material

Sources.

Elimination of unnecessary

delay in global development.

Availability of safe, quality and

efficacious new medicines.

Promote patient health.Tuesday, October 10, 2017 5Ref.: Forensic Pharmacy by B.S. Kuchekar

MISSION

Tuesday, October 10, 2017 6

Make recommendations towards

achieving greater harmonization

in Interpretation and Application

of Technical Guidelines and

Requirements for

Pharmaceutical Product

Registration.Ref.:

https://www.slideshare.net/naveenniper/ich-guidelines-12769383

ICH Organizational Structure

The ICH structure consists of the

• ICH Steering Committee

• Global Cooperation Group (GCG)

• ICH MedDRA Management Board

• ICH Coordinators,

• ICH Secretariat and

• ICH Working Groups.

Tuesday, October 10, 2017Ref.:

https://www.slideshare.net/mdgayas70/ich-guidelines-seminar

7

Global Cooperation Group

(GCG)• The ICH Global Cooperation Group (GCG)

was formed on March 11, 1999, as a

subcommittee of the ICH Steering Committee.

• It is made up of one representative from each

of the six parties on the ICH Steering

Committee, plus the IFPMA.

• The ICH Observers, WHO, Canada and EFTA

are also part of the GCG.



8

ICH parties• EU

• EFPIA (European federation of pharmaceutical industries’ associations)

• MHLW (Ministry of health, Labor and welfare, Japan)

• JPMA (Japan Pharmaceuticals manufacturers Association)

• US FDA

• PhRMA (The Pharmaceutical Research and Manufacturers of America)

• Observers : WHO, TPP(Canada)

• International Federation of Pharmaceutical

Manufacturer’s Association

6 Parties of ICH



9

1. • INTRODUCTION

2. • HARMONIZATION EFFORTS



5. •CTD

6. •REFERENCES

10Tuesday, October 10, 2017

INTERNATIONAL

HARMONIZATION:The process of standardizing laws, regulations and

practices to facilitate the expansion, fairness and

efficiencies of competing in globalized economy.



INNOVATION

SCIENCE

HARMONIZATION EFFORTSICH 2009-2010

1st ICH Guideline on Gene Therapy

Progress on interface between ICH and Standards

Development Organization.

Expansion of Global Cooperation Group

Global Harmonization Task Force

Efforts to harmonize medical device regulatory

requirements and terminology

Asia Pacific Economic Cooperation

Life Science Innovation Forum 2009

Pharmaceutical Inspection Cooperation SchemeTuesday, October 10, 2017 13

Ref.: https://www.slideshare.net/NailaKanwal/harmonization-and-its-impact-theme2

Positive impacts of HarmonizationEstablished a set of standards

for the manufacturing

processes of new drugs.

Agree on one set of scientific

rules to running clinical trials.

Reducing Expenses (In terms of Research animals and human testing).

Faster Approvals

Harmonized documentation.

Ensured similar application process for drug approval in all countries.

Ensured that research findings from one member country will be accepted by all other countries (With some exceptions)

Provision of quality drugs with Efficacy.

Tuesday, October 10, 2017 14Ref.:

https://www.slideshare.net/NailaKanwal/harmonization-and-its-impact-theme2

Drawbacks of HarmonizationPublic accountability is missing.

Reduced the safety tests with respect to trials

Potentially weaken the public health.

Limit Competition.

Raised the cost of medicine.

Threatened the production of inexpensive generic drugs.



1. • INTRODUCTION


3. • BASIC PRINCIPLES


5. •CTD


BASIC PRINCIPLES


SAFETY GUIDELINES• S1A – S1C:

CARCINOGENICITY STUDIES

• S2: GENOTOXICITY STUDIES

• S3A – S3B: TOXICOKINETICS & PHARMACOKINETICS

• S4: TOXICITY TESTING

• S5: REPRODUCTIVE TOXICOLOGY

• S6: BIOTECHNOLOGICAL PRODUCTS

• S7A – S7B: PHARMACOLOGY STUDIES

• S8: IMMUNITOXICOLOGY STUDIES

• S9: NON CLINICAL EVALUATION FOR ANTICANCER PHARMACEUTICALS

• S10: PHOTOSAFETY EVALUATION

• S11: NONCLINICAL SAFETY TESTING


http://www.ich.org/products/guidelines/safety/article/safety-guidelines.html

EFFICACY GUIDELINES• E1: CLINICAL SAFETY FOR

DRUGS USED IN LONG-TERM TREATMENT

• E2A – E2F: PHARMACOVIGILANCE

• E3: CLINICAL STUDY REPORTS

• E4: DOSE RESPONSE STUDIES

• E5: ETHNIC FACTORS IN THE ACCEPTABILITY OF FOREIGN CLINICAL DATA

• E6: GOOD CLINICAL PRACTICE

• E7: CLINICAL TRIALS IN GERIATRIC POPULATION

• E8: GENERAL CONSIDEARTIONS FOR CLINICAL TRIALS

• E9: STATISTICAL PRINCIPLES FOR CLINICAL TRIALS

• E10: CHOICE OF CONTROL GROUP IN CLINICAL TRIALS

• E11: CLINICAL TRIALS IN PEDIATRIC POPULATION


http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html

EFFICACY GUIDELINES

(CONTD.)• E12: CLINICAL

EVALUATION BY THERAPEUTIC CATEGORY

• E14: CLINICAL EVALUATION OF QT

• E15: DEFINITIONS IN PHARMCOGENETICS / PHARMACOGENOMICS

• E16: QUALIFICTION OF GENOMIC BIOMARKERS

• E17: MULTI-REGIONAL CLINICAL TRIALS

• E18: GENOMIC SAMPLING


http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html

MULTIDISCIPLINARY

• M7: GENOTOXIC IMPURITIES

• M8: eCTD

• M9: BIOPHARMACEUTICS CLASSIFICATION SYSTEM-BASED BIOWAIVERS

• M10: BIOANALYTICAL METHOD VALIDATION


• M1: MEDDRA TERMINOLOGY

• M2: ELECTRONIC STANDARDS

• M3: NONCLINICAL SAFETY STUDIES

• M4: CTD• M5: DATA ELEMENTS

ANDSTANDARDS FOR DRUG DICTIONARIES

• M6: GENE THERAPYRef.:

http://www.ich.org/products/guidelines/multidisciplinary/article/multidisciplin

ary-guidelines.html

QUALITY GUIDELINES

• Q1A – Q1F: STABILITY

• Q2: ANALYTICAL VALIDATION

• Q3A – Q3D:IMPURITIES

• Q4A – Q4B:PHARMACOPOEIAS

• Q5A – Q5E: QUALITY OF BIOTECHNOLOGICAL PRODUCTS

• Q6A – Q6B: SPECIFICATIONS

• Q7: G.M.P.

• Q8: PHARMACEUTICAL DEVELOPMENT

• Q9: QUALITY RISK MANAGEMENT

• Q10:PHARMACEUTICAL QUALITY SYSTEM

• Q11: DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES

• Q12: LIFECYCLE MANAGEMENT


http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html

1. • INTRODUCTION



4. • Q 11 GUIDELINE

5. •CTD



Issued in Nov. 2012

Development and Manufacture of Drug Substances

Quality Principles for Manufacturing Process

Development:1. Drug-substance quality linked to drug product

2. Process-development tools

3. Approaches to development

4. Drug-substance CQAs

5. Linking material attributes and process parameters to drug

substance CQAs

6. Design space Ref.: http://www.pharmtech.com/understanding-ich-q11-fdas-guidance-development-

and-manufacture-drug-substances


DOCUMENTATION REQUIRED: An overall summary of the development process including: CQAs;

description of design stages; description of material attributes;

description of process parameters; and description and

development of design spaces should be provided.

CQAs of the drug substance shall be listed.

A detailed discussion of the manufacturing process history needs to

be provided.

Manufacturing development studies, including risk assessments

employed in support of commercial development, including the

control strategy, must be provided.

(CONTD.)

Ref.: http://www.pharmtech.com/understanding-ich-q11-fdas-guidance-development-



DESCRIPTION OF PROCESS & PROCESS

CONTROL EMPLYOED IN MANUFACTURING:

Material-selection process Selection of starting materials for synthetic drug

substances

Selection of starting materials for semisynthetic drug

substances

The selection of source and starting materials for

biotechnical/biological drug substances

(CONTD.)




DESCRIPTION OF PROCESS & PROCESS

CONTROL EMPLYOED IN MANUFACTURING:

(CONTD.)

Control strategy: Controls employed for raw

materials

Controls associated with

the design manufacturing

process

In-process controls (i.e.,

testing and process control

points)

Controls placed on the drug

substance (e.g., release

testing)

Submission of relevant

information: Description of manufacturing-

process controls

Controls employed for

materials

Controls for identified critical

process steps

Controls for the drug substance

Container closure systems Ref.: http://www.pharmtech.com/understanding-ich-q11-fdas-guidance-development-



PROCESS VALIDATION:

EMPLOYMENT OF CTD FORMAT FOR INFORMATION

SUBMISSION:

LIFECYCLE MANAGEMENT:

Process-development activities

Technology-transfer activities

Process-validation studies

Change-management activities

(CONTD.)



1. • INTRODUCTION




5. • CTD


COMMON TECHNICAL

DOCUMENT• M4 GUDELINE (July 2003)

• The agreement to assemble all the Quality, Safety

and Efficacy information in a common format

• Organized into 5 modules

• Module 1 is region specific and Modules 2, 3, 4

and 5 are intended to be common for all regionsTuesday, October 10, 2017 31

Ref.: http://www.ich.org/products/ctd.html

1. • INTRODUCTION




5. •CTD

6. • REFERENCES33Tuesday, October 10, 2017

REFERENCES1. Forensic Pharmacy by Dr. B. S. Kuchekar, A. M. Kadtare

and Sachin Itkar, Nirali Prakashan, Page no. 16.16 –16.25

2. https://www.slideshare.net/naveenniper/ich-guidelines-12769383

3. http://slideplayer.com/slide/4789228/

4. https://www.slideshare.net/NailaKanwal/harmonization-and-its-impact-theme2

5. https://www.slideshare.net/bharathpharmacist/ich-guidelines-39685947

6. http://www.ich.org/products/guidelines/

7. ICH Q 11 Step 4 GuidelinesTuesday, October 10, 2017 34

https://www.slideshare.net/naveenniper/ich-guidelines-12769383

http://slideplayer.com/slide/4789228/


https://www.slideshare.net/bharathpharmacist/ich-guidelines-39685947

http://www.ich.org/products/guidelines/

35Tuesday, October 10, 2017

Ich ppt

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Transcript of Ich ppt