The document outlines the establishment and objectives of the International Conference on Harmonization (ICH), founded in April 1990 to coordinate regulatory activities across Europe, Japan, and the United States. It focuses on enhancing the harmonization of technical requirements for pharmaceutical product registration and fostering dialogue between regulatory authorities and the pharmaceutical industry for public health protection. The ICH, established as a non-profit in 2015, aims to maintain updated guidelines and standards to facilitate research and development in pharmaceuticals.

1. ICHS U B J E C T : Q U A L I T Y A S S U R A N C E [ Q A ]
B Y – D I V Y P A T E L [ ]
I N T E R N A T I O N A L C O U N C I L F O R H A R M O N I S A T I O N

2. WEBISTE : HTTPS://WWW.ICH.ORG/

3. WHY ? WHEN ? WHERE ? HOW ? _
• Europe, Japan, and the United States began creating plans for harmonization. The
International Conference on Harmonization of Technical Requirements for Registration
of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting
in Brussels . ICH had the initial objective of coordinating the regulatory activities of the
European, Japanese and United States regulatory bodies in consultation with the
pharmaceutical trade associations from these regions, to discuss and agree the
scientific aspects arising from product registration
• The aim of these reforms was to transform ICH into a truly global initiative supported
by a robust and transparent governance structure.

4. .

5. MISSION AND VISION :
With ICH’s establishment as an international non-profit Association under Swiss law on October 23, 2015,
ICH’s mission has been embodied in its Articles of Association as follows:
• To make recommendations towards achieving greater harmonisation in the interpretation and
application of technical guidelines and requirements for pharmaceutical product registration and the
maintenance of such registrations;
• To maintain a forum for a constructive dialogue on scientific issues between regulatory authorities and
the pharmaceutical industry on the harmonisation of the technical requirements for pharmaceutical
products;
• To contribute to the protection of public health in the interest of patients from an international
perspective;
• To monitor and update harmonised technical requirements leading to a greater mutual acceptance of
research and development data;
• To avoid divergent future requirements through harmonisation of selected topics needed as a result of
therapeutic advances and the development of new technologies for the production of medicinal
products;
• To facilitate the adoption of new or improved technical research and development approaches which
update or replace current practices;
• To encourage the implementation and integration of common standards through the dissemination
of, the communication of information about and coordination of training on, harmonised guidelines
and their use;
• And to develop policy for the ICH Medical Dictionary for Regulatory Activities Terminology (MedDRA)

6. ORGANIZATIONAL CHART :

7. MEMBERS IN ICH :
• There are numerus members that are available on website given below including their
origin of country ;;
• https://www.ich.org/page/members

8. GUIDELINES
•Q – quality guideline
•S - safety guideline
•E – efficacy guideline
•M – multidisciplinary guideline

9. QUALITY GUIDELINES IN BRIEF
• Q1A-Q1F – Stability
• Q2 ANALYTICAL VELIDATION
• Q3A-Q3D – IMPURITIES
• Q4A-Q4B – PHARMACOPOEIAS
• Q5A-Q5E – QUALITY OF BIOTECHNOLOGY PRODUCT
• Q6A – Q6B –SPECIFICATIONS

10. QUALITY GUIDELINES IN BRIEF
• Q7- GMP
• Q8 – PHARMACEUTICAL DEVELOPMENT
• Q9 - QUALITY RISK MANAGEMENT
• Q10 – PHARMA QUALITY SYSTEM
• Q11 - DEVELOPMENT AND MANUFACTURING OF DRUG
SUBSTANCE

11. QUALITY GUIDELINES IN BRIEF
• Q12 LIFECYCLE MANAGEMENT
• Q13 – CONTINOUS MANUFACTURING OF DRUG
SUBSTANNCE AND DRUG PRTODUCT
• Q14 – ANALYTICAL PROCEDURE DEVELOPMENT

12. THANK YOU…
Divy M. Patel
E-mail : divymanish@gmail.com