[ANAL-LEC-PRE-01] ICH GUIDELINES

THIS FLASH CARDS IS ABOUT ANALYSIS II: ICH GUIDELINES.

International Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use

ICH is also known as?

ICH

This is a project, that brings together regulatory authorities of Europe, Japan & USA, to discuss scientific & technical aspects of pharmaceutical product registration.

Europe, Japan, and USA

Which three (3) nations are members of ICH?

Geneva, Switzerland

The ICH Secretariat is based where?

• Ministry of Health, Labour, and Welfare (MHLW)

• Japan Pharmaceutical Manufacturers Association (JPMA)

ICH MEMBERS:

In Japan, the members include:

• European Union (EU)

• European Federation of Pharmaceutical Industries and Associations (EFPIA)

ICH MEMBERS:

In Europe, the members include:

• Food and Drug Administration (FDA)

• Pharmaceutical Research and Manufacturers of America (PhRMA)

ICH MEMBERS:

In the USA, the members include:

• Observers from the WHO

• European Free Trade Association (EFTA)

• Canada

ICH MEMBERS:

Additional members include:

Ministry of Health, Labour, and Welfare

MHLW stands for?

Japan Pharmaceutical Manufacturers Association

JPMA stands for?

European Union

EU stands for?

European Federation of Pharmaceutical Industries and Associations

EFPIA stands for?

Food and Drug Administration

FDA stands for?

Pharmaceutical Research and Manufacturers of America

PhRMA stands for?

European Free Trade Association

EFTA stands for?

• Steering committee

• Coordinators

• Secretariat

• Working Groups

ICH structure (organization) consists of:

Steering Committee

ICH ORGANIZATION:

This body governs ICH, determines policies and procedure for ICH, selects topics for harmonization, and monitors progress of harmonization initiatives.

Steering Committee

Who governs the ICH?

Steering Committee

Who determines policies and procedures for ICH?

Steering Committee

Who selects topics for harmonization?

2

How many seats are there for each of the six (6) ICH parties on the ICH steering committee?

Coordinators

ICH ORGANIZATION:

Helps in smooth functioning of ICH. They are nominated by each of the six (6) parties. They also act as the main contact point with the ICH Secretariat.

Coordinators

Who helps in the smooth functioning of ICH?

Coordinators

They are nominated by each of the six (6) parties.

Coordinators

Who acts as the main contact point with the ICH Secretariat?

Secretariat

ICH ORGANIZATION:

Prepares for documentation of meetings of Steering Committee. Coordinates preparations for Working Group & Discussion Group meetings.

Secretariat

Who prepares for documentation of meetings of the Steering Committee?

Secretariat

Who coordinates preparations for the Working Group and Discussion Group meetings?

• ICH guidelines

• General ICH process

What are the two (2) information that can be obtained from ICH Secretariat?

Working Group

ICH ORGANIZATION:

Based on type of harmonization activity needed, the Steering Committee will endorse establishment of one of the 3 types of working groups.

• Expert Working Group (EWG)

• Implementation Working Group (IWG)

• Informal Working Group

What are the three (3) types of working groups whose establishment the Steering Committee will endorse?

Expert Working Group

EWG stands for?

Implementation Working Group

IWG stands for?

Steering Committee

ICH operates through the _____, with administrative support from Secretariat & Coordinators.

Secretariat and Coordinators

ICH operates through the Steering Committee, with administrative support from ________________.

Twice a year

How many times a year does the Steering Committee meet?

Step 1

STEPS IN THE ICH PROCESS:

Drafts are prepared circulated through many revisions leads to assimilation of a “final harmonized draft”.

Step 2

STEPS IN THE ICH PROCESS:

Draft is signed by EWG forwarded to Steering Committee for signing signifies acceptance for consultation by each of the 6 co-sponsors.

Step 3

STEPS IN THE ICH PROCESS:

3 regulatory sponsors initiate their normal consultation process to receive comments.

Step 4

STEPS IN THE ICH PROCESS:

• Reached, when the Steering Committee agrees that there is sufficient scientific consensus on technical issues.

• This endorsement is based on signatures from the 3 regulatory parties to ICH, affirming that the Guideline is recommended for adoption by the regulatory bodies of the 3 regions.

Step 5

STEPS IN THE ICH PROCESS:

Guidelines incorporated into national/regional internal procedures (implementation in the 3 ICH regions).

• Quality

• Efficacy

• Safety

• Multidisciplinary

ICH guideline topics include:

Quality

ICH GUIDELINE TOPICS:

Refer to topics related to chemical and pharmaceutical quality assurance.

(e.g., stability testing, impurity testing, etc.)

Efficacy

ICH GUIDELINE TOPICS:

Refers to topics, that deal with clinical studies in human subjects.

(e.g., dose-response studies, good clinical practices, etc.)

Safety

ICH GUIDELINE TOPICS:

Refers to topics, that deal with in-vitro and in-vivo pre-clinical studies.

(e.g., carcinogenicity testing, genotoxicity testing, etc.)

Multidisciplinary

ICH GUIDELINE TOPICS:

Refer to topics that do not fit uniquely into any of the above categories. Hence also known as “cross-cutting topics”.

Cross-cutting topics

Multidisciplinary is also known as?

Q1A-Q1F

QUALITY GUIDELINES:

Stability

Stability

Q1A-Q1FF is for?

Q2

QUALITY GUIDELINES:

Analytical Validation

Analytical Validation

Q2 is for?

Q3A-Q3E

QUALITY GUIDELINES:

Impurities

Impurities

Q3A-Q3E is for?

Q4A-Q4B

QUALITY GUIDELINES:

Pharmacopoeias

Pharmacopoeias

Q4A-Q4B is for?

Q5A-Q5E

QUALITY GUIDELINES:

Quality of Biotechnological Products

Quality of Biotechnological Products

Q5A-Q5E is for?

Q6A-Q6B

QUALITY GUIDELINES:

Specifications

Specifications

Q6A-Q6B is for?

Q7

QUALITY GUIDELINES:

Good Manufacturing Practice

Good Manufacturing Practice

Q7 is for?

Q8

QUALITY GUIDELINES:

Pharmaceutical Development

Pharmaceutical Developement

Q8 is for?

Q9

QUALITY GUIDELINES:

Quality Risk Management

Quality Risk Management

Q9 is for?

Q10

QUALITY GUIDELINES:

Pharmaceutical Quality System

Pharmaceutical Quality System

Q10 is for?

Q11

QUALITY GUIDELINES:

Development and Manufacture of Drug Substances

Development and Manufacture of Drug Substances

Q11 is for?

Q12

QUALITY GUIDELINES:

Lifecycle Management

Lifecycle Management

Q12 is for?

Q13

QUALITY GUIDELINES:

Continuous Manufacturing of Drug Substances and Drug Products

Continuous Manufacturing of Drug Substances and Drug Products

Q13 is for?

Q14

QUALITY GUIDELINES:

Analytical Procedure Development

Analytical Procedure Development

Q14 is for?

Stability Testing of New Drug Substances and Products

Q1A-Q1F GUIDELINES:

The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug product.

Photostability Testing of New Drug Substances and Products

Q1A-Q1F GUIDELINES:

• Give guidance on the basic testing protocol required to evaluate the light sensitivity and stability of new drugs and products.

Stability Testing for New Dosage Forms

Q1A-Q1F GUIDELINES:

• Gives guidelines for new formulations of already approved medicines.

• Defines the circumstances under which reduced stability data can be accepted.

Evaluation of Stability Data

Q1A-Q1F GUIDELINES:

• Addresses the evaluation of stability data that should be submitted in registration applications for new molecular entities and associated drug products.

• Provides recommendations on establishing shelf lives for drug substances and drug products intended for storage at or below “room temperature”.

Validation of Analytical Procedures-Text and Methodology

Q2 GUIDELINES:

• The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose.

• Gives validation parameters needed for a variety of analytical methods.

• Discusses the characteristics that must be considered during the validation of the analytical procedures.

• Identification tests

• Quantitative tests for impurities content

• Limit tests for the control of impurities

• Quantitative tests of the active moiety in samples of drug substance or drug product or other selected components in the drug product

Q2 GUIDELINES:

What are the Types of Analytical Procedures to be validated?

Impurities in New Drug Substances

Q3A-Q3D GUIDELINES:

Guideline addresses the chemistry and safety aspects of impurities, including the listing of impurities, threshold limit, identification and quantification.

• Organic impurities (process-and-drug related)

• Inorganic impurities

• Residual solvents

Q3A-Q3D GUIDELINES:

The impurities are classified into three (3). What are they?

2ppm

Q3A-Q3D GUIDELINES:

Impurities: Guideline for Residual Solvents:

• BENZENE

4ppm

Q3A-Q3D GUIDELINES:

Impurities: Guideline for Residual Solvents:

• CARBON TETRACHLORIDE (CCl₄)

5ppm

Q3A-Q3D GUIDELINES:

Impurities: Guideline for Residual Solvents:

• DICHLOROMETHANE

8ppm

Q3A-Q3D GUIDELINES:

Impurities: Guideline for Residual Solvents:

• DICHLOROETHANE

410ppm

Q3A-Q3D GUIDELINES:

Impurities: Guideline for Residual Solvents:

• ACETONITRILE

60ppm

Q3A-Q3D GUIDELINES:

Impurities: Guideline for Residual Solvents:

• CHLOROFORM

360ppm

Q3A-Q3D GUIDELINES:

Impurities: Guideline for Residual Solvents:

• CHLOROBENZENE

Evaluation and Recommendation of Pharmacopeial Texts

Q4 GUIDELINES:

This document describes a process for the evaluation and recommendations given by the Expert Working Group (EWG), for selecting pharmacopeial texts to facilitate their recognition by regulatory authorities for use (interchangeable in the ICH regions).

Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

Q5 GUIDELINES:

• Concerned with testing and evaluation of viral safety of biotechnology products derived from cell lines of human or animal origin (i.e., mammalian, avian, insect).

• Objective is to provide a general framework for virus testing experiments for the evaluation of virus clearance and the design of viral tests and clearance evaluation studies.

Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products

Q5 GUIDELINES:

Objective of this guideline is to provide broad guidance on appropriate standards for cell substrate.

Specifications for New Drug Substances and Products

Q6 GUIDELINES deals with the?

Specifications-Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products

Q6 GUIDELINES:

• Main objective of this guideline is to establish a single set of global specifications for new drug substances & drug products.

• This guideline addresses specifications, i.e., those tests, procedures, and acceptance criteria, which play a major role in assuring the quality of the new drug substance and new drug product during shelf life.

Good Manufacturing Practice Guidelines for Active Pharmaceutical Ingredients

Q7 GUIDELINES deals with the?

Q7

This guideline’s main objective is to maintain the quality of the active pharmaceutical ingredients (API).

Pharmaceutical Developement

Q8 GUIDELINES deals with the?

Pharmaceutical Development of Drug Products

What is the main objective of Q8 guidelines?

Q8

What guideline is this?

• The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product.

• The Pharmaceutical Development section also describe the type of dosage form and the formulation that are suitable for the intended use.