This document summarizes ICH Q8 guidelines on pharmaceutical development. It outlines the key components of drug development, including drug substances, excipients, formulation development, manufacturing process development, container closure systems, and compatibility studies. The objectives of Q8 are to design a quality product and manufacturing process using scientific approaches and quality risk management. It advocates moving from quality by testing to quality by design to build quality in from the beginning and continuously improve through the product lifecycle.

1. ICH Q8
(PHARMACEUTICAL DEVELOPMENT)
PALAKDEEP KAUR
MRSPTU(Bathinda)

2. 1. Introduction
1.1 Objective
2. Pharmaceutical Development
2.1 Components of Drug Product
2.1.1 Drug Substance
2.1.2 Excipients
2.2 Drug Product
2.2.1Formulation Development
2.2.2 Overages
2.2.3 Physiochemical and Biological Properties
2.3 Manufacturing Process Development
2.4 Container Closure System
2.5 Microbial Attributes
2.6 Compatibility
3. Layout of Quality by Design
4. Conclusion
CONTENTS

3. 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.
I
N
T
R
O
D
U
C
T
I
O
N

4. OBJECTIVE
• This guideline describes the suggested contents
for the 3.2.P.2 (Pharmaceutical Development)
section of a regulatory submission in the
Common Technical Document (CTD) format.
• To understand the concept of ICH guidelines Q8
• To know the importance and study the benefits
of ICH guidelines Q8.

5. PHARMACEUTICAL
DEVELOPMENT
To design a quality product and its manufacturing
process to consistently deliver the intended performance
of the product.
Provide scientific understanding to support the
establishment of the design space, specifications, and
manufacturing controls.

6. COMPONENTS
OF
DRUG
PRODUCT
2.1.1
DRUG
SUBSTANCES
2.1.2
EXCIPIENTS

7. DRUG SUBSTANCES
“The physicochemical and biological properties of the
drug substance that can influence the performance of
the drug product and its manufacturability.” Examples
of physicochemical and biological properties that
might need to be examined include
•Solubility
•Water content
•Particle size
•Crystal properties
•Permeability

8. EXCIPIENTS
The excipients chosen, their concentration, and the
characteristics that can influence the drug product
performance or manufacturability.
The compatibility of the drug substance with
excipients should be evaluated. For products that
contain more than one drug substance, the
compatibility of the drug substances with each other
should also be evaluated.

9. DRUG
PRODUCT
2.2.1
FORMULATION
DEVELOPMENT
2.2.2
OVERAGES
2.2.3
PHYSIOCHEMICAL
& BIOLOGICAL
PROPERTIES

10. FORMULATION DEVELOPMENT
 Identification of those attributes that are critical to the quality
of the drug product.
 Highlight the evolution of the formulation design from initial
concept up to the final design.
 Information from comparative in vitro studies (e.g.,
dissolution) or comparative in vivo studies (e.g., BE) that
links clinical formulations to the proposed formulation.

11. OVERAGES
Overages in the manufacture of the drug product,
whether they appear in the final formulated product or
not, should be justified considering the safety and
efficacy of the product.
Information should be provided on the
1) Amount of overage,
2) Reason for the overage (e.g., to compensate for
expected and documented manufacturing losses),
3) Justification for the amount of overage.

12. PHYSIOCHEMICAL&
BIOLOGICAL PROPERTIES
The physicochemical and biological properties
relevant to the safety, performance or
manufacturability of the drug product should be
identified and discussed.
This includes the physiological implications of
drug substance and formulation attributes.

13. M
A
N
U
F
A
C
T
U
R
I
N
G
PROCESS
DEVELOPMENT
•Address the selection of the
manufacturing process and confirm the
appropriateness of the components.
•Appropriateness of the equipment used
for the intended products should be
discussed.
•The manufacturing process
development programme or process
improvement programme should
identify any critical process parameters
that should be monitored or controlled
(e.g., granulation end point) to ensure
that the product is of the desired quality.

14. C
O
N
T
A
I
N
E
R
CLOSURE
SYSTEM
•The choice for selection of the
container closure system for the
commercial product should be
discussed.
•The choice of materials for
primary packaging and secondary
packaging should be justified.
•A possible interaction between
product and container or label
should be considered.

15. M
I
C
R
O
B
I
O
L
O
G
I
C
A
L
ATTRIBUTES
•The selection and effectiveness of
preservative systems in products
containing antimicrobial
preservative or the antimicrobial
effectiveness.
• For sterile products, the integrity of
the container closure system as it
relates to preventing microbial
contamination.
•The lowest specified concentration
of antimicrobial preservative should
be justified in terms of efficacy and
safety.

16. C
O
M
P
A
T
I
B
I
L
I
T
Y
The compatibility of the drug
product with reconstitution
diluents (e.g., precipitation,
stability) should be addressed to
provide appropriate and
supportive information for the
labeling.

17. LAY OUT OF QUALITY BY DESIGN
1. TARGET
PRODUCT
PROFILE
2. CRITICAL
QUALITY
ATTRIBUTES
4. ESTABLISH
DESIGN
SPACE
3. LINK MAs
AND PPs TO
CQAS
6. PRODUCT
LIFECYCLE
MNGMNT
5. ESTABLISH
CONTROL
STRATEGY

18. Agencies and Industry are moving from ‘blind’
compliance to ‘science and risk-based’ compliance
Industry wants this to be global. This evolution is based
on process understanding and continuous improvement
throughout the product life cycle Traditional process
validation being replaced by a much better alternative. -
Building in quality. - Continuous quality verification
and improvement. Moving from ‘Quality by Testing’ to
‘Quality by Design’ should, in principle, allow
significant regulatory flexibility helps both regulators
and industry focus on higher risk or added value
activities.
CONCLUSION