What is ICH Q8 guidelines? Image result for ICH Pharmaceutical development guideline-Q8 The ICH Q8 guideline is intended to provide guidance on the contents of Section 3.2. P. 2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH topic M4).

1. ICH Pharmaceutical development
guideline-Q8
Presented by:-Prof. Vedanshu Malviya
P.R.Pote Patil Collage Of Pharmacy Amravati,
B Pharm Final Year, 2021-22

2. Content
o Introduction
o Pharmaceutical Development
o Components of Drug Product
o Drug Product
o Manufacturing Process Development
o Container Closure System
o Microbial Attribute
o Compatibility
o Cconclusion

3. Introduction
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.

4. Objective
o 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.
o To understand the concept of ICH guidelines Q8
o To know the importance and study the benefits
of ICH guidelines Q8.

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

6. Components of Drug
Product
Drug
Substance
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
o Solubility
o Water content
o Particle size
o Crystal properties
o Permeability

8. EXCIPIENTS
o The excipients chosen, their concentration, and
the characteristics that can influence the drug
product performance or manufacturability.
o 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
FORMULATION
DEVELOPMENT
Overages
PHYSIOCHEMICAL
& BIOLOGICAL
PROPERTIES

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

11. OVERAGES
o 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.
o Information should be provided on the
a. Amount of overage,
b. Reason for the overage (e.g., to compensate
for expected and documented manufacturing
losses),
c. Justification for the amount of overage.

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

13. Manufacturing Process
Development
o Address the selection of the manufacturing
process and confirm the appropriateness of the
components.
o Appropriateness of the equipment used for the
intended products should be discussed.
o 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. Container Closure System
o The choice for selection of the container closure
system for the commercial product should be
discussed.
o The choice of materials for primary packaging
and secondary packaging should be justified.
o A possible interaction between product and
container or label should be considered.

15. Microbial Attribute
o The selection and effectiveness of preservative
systems in products containing antimicrobial
preservative or the antimicrobial effectiveness.
o For sterile products, the integrity of the container
closure system as it relates to preventing
microbial contamination.
o The lowest specified concentration of
antimicrobial preservative should be justified in
terms of efficacy and safety.

16. Compatibility
o 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. Conclusion
The compatibility of 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. The drug
product with reconstitution diluents (e.g., precipitation, stability)
should be addressed to provide appropriate and supportive
information for the labeling.

18. References
o Dr. Fritz Erni : Consensus on New ICH Pharmaceutical Development
Guideline, Regulatory Affairs Journal February 2005, page 89-90
oMarieke E. Klijn, Jürgen Hubbuch biopharmaceutical formulation
characterization and development studies, European Journal of Pharmaceutics
and Biopharmaceutics, 10.1016/j.ejpb.2021.05.013, 165, (319-336), (2021).
oLjuba Karanakov, Jasmina Tonic-Ribarska , Marija Glavas-Dodov, Suzana
Trajkovic-Jolevska, Analysis and critical review of ICH Q8, Q9 and Q10 from a
generic pharmaceutical industry view point, Macedonian Pharmaceutical
Bulletin, 10.33320/maced.pharm.bull.2011.57.010, 57, (85-96), (2011).