This document summarizes ICH Q8 guidelines for pharmaceutical product development. It discusses key aspects of quality by design (QbD) like quality target product profiles, critical quality attributes, and critical process parameters. The document also outlines the contents recommended for the quality module in a common technical document, including drug substances, excipients, formulation development, manufacturing processes, containers and closures, microbiological attributes, and compatibility studies. The goal of QbD and ICH Q8 is to build quality into pharmaceutical products through scientific approaches and risk management during development.

1. ICH Q8 Guidelines .
Prepared By :- Arjun S.Dhawale
M.Pharm 2 sem Pharmaceutics
Kamla Nehru College of Pharmacy
Butibori , Nagpur .

2. Content :-
• Introduction .
• QbD approach .
• ICH Q8 R2 guidelines .
• Contents for CTD module 3 .
• Compound of drug product .
• Formulation development .
• Container and closure system .
• Microbiological attributes .
• Compatibility .
• Conclusion .
• Reference .

3. Introduction :-
This guideline describes the suggested contents for the (Pharmaceutical
Development) section of a regulatory submission in the ICH M4 Common
Technical Document (CTD) format. The Pharmaceutical Development section
provides an opportunity to present the knowledge gained through the
application of scientific approaches and quality risk management to the
development of a product and its manufacturing process. It is first produced for
the original marketing application and can be updated to support new
knowledge gained over the lifecycle of a product.
QbD assures the quality of a pharmaceutical product through scientific
development and risk management tools , and will eventually enable real-time
release , regardless of the formulation type .

4. QbD approach :-
Quality Target Product Profile (QTPP) : According to the
ICH Q8 guideline , QTPP is a prospective summary of the
quality characteristics of a drug product to ensure the
desired quality , taking into account safety and efficacy of
that drug product .
Through the scientifically based process of product
development , critical process parameters (CPPs) , critical
quality attributes (CQAs) of the product are identified .

5. ICH Q8 (R2) :-
• The ICH Q8 guidelines describes GOOD PRACTICES
FOR PHARMACEUTICAL PRODUCT DEVELOPMENT .
• ICH Q8 Pharmaceutical Development describes the
principles of QbD , outlines the key elements , and
provides illustrative examples for pharmaceutical drug
products .
• It is often emphasized that the quality of a pharmaceutical
product should be built by Design rather that by testing
alone .

6. Contents for CTD quality Module 3 :-
• Components of drug product .
• Formulation development .
• Manufacturing process development .
• Container Closure System .
• Microbiological Attributes .
• Compatibility .

7. Components of drug prodt given by ICH Q8 :-
Drug substances :-
The physicochemical and biological properties of the drug
substance that can influence the performance of the drug
product and its manufacturing .
Excipients :-
The excipients chosen , their concentration ad the
characteristics that can influence the drug product
performance or manufacturing should be discussed relative
to the respective function of esch excipients .

8. Formulation Development :-
The development of the formulation , including identification
of those attribution are critical to the quality of the drug .
The product are also highlighted the evolution of the
formulation design and initial concept up to the final design .
A successful correlation can assiat in the selection of
appropriate dissolution acceptance criteria and can
potentially reduce the need for further bioequivalance
studies following changes to the product or its
manufacturing process .

9. Containers and closure system :-
The choise for selection of the container closure system for
the commercial product should be discussed .
THe choise of the material for primary packaging and
secondary packaging should be justified .
A possible interaction between product and container or
label should be considered .

10. Microbiological attributes :-
The selection and effectiveness of preservative system is
products containing antimicrobial preservative or the
antimicrobial effectiveness of products that are inheretly
atimicrobial .
For sterile products , the integrity of the container closure
system as it relates to preventing microbial contamination .

11. Compatibility :-
The compatibility of the drug product with reconstitution
diluents should be addressed to provide appropriate and
supportive information for the labelling .
This information should cover the recommended in use
shelf life , at the recommended storage temperature and at
the likely extremes of concentration .

12. Conclusion :-
Concepts of QbD are ever growing need for better
understanding of the formulation and process development
by pharmaceutical scientists.
Benefits of QbD application for both regulation agencies
and manufacturing have been proven .

13. Reference :-
• Google.com
• Computer aided applications in pharmaceutical
technology , by Jelena Djuris .

14. Thank You