The document discusses the International Conference on Harmonization (ICH) guidelines related to quality (Q) and safety (S) for pharmaceuticals, emphasizing their importance in ensuring the safety, quality, and efficacy of medicines. It outlines various specific guidelines under these categories, including stability testing, analytical validation, and carcinogenicity studies, among others. The goal of the ICH is to promote global harmonization in the development and approval process for high-quality medications.

1. Seminar on
ICH GUIDELINES Q & S
Presented By-:
Suryawanshi Nishinandan R.
(M Pharm 1 St
Year, Sem-I)
Dept. Of Pharmaceutics
Roll No:-5006
Guided by :-
Dr. A. V. Moholkar
Channabasweshwar Pharmacy College (degree), Latur.

2. What dose ICH stand for?
 ICH is stand for the “International Conference on
Harmonization of Technical Requirement for
Pharmaceuticals for Human Use”
 ICH brings together the medicines regulatory authorities
and pharmaceutical industry around the world, such as
European Union, Japan and USA in Scientific and
Technical discussion of the testing procedure required to
assess and ensure the safety, quality and efficacy of
medicines.

3. Goal of ICH
 To achieve greater harmonisation worldwide for
the development and approval of safe, effective,
and high-quality medicines in the most resource-
efficient manner.
 To make information available on ICH, ICH
activities and ICH guidelines to any country or
company that request the information & to
promote mutual understanding.

4. ICH Guidelines
Q (Quality) (Q1-Q11) S (Safety) (S1-S10, M3)
Related to chemical &
pharmaceutical Quality
Assurance ( Stability Testing,
Impurity Testing etc.)
Related to in vitro & in
vivo pre-clinical studies
(Carcinogenicity Testing,
genotoxicity Testing,
etc.)

5. Quality
 Q1- Stability
 Q2- Analytical Validation
 Q3- Impurities
 Q4- Pharmacopoeias
 Q5Quality of Biotechnological Products

6.  Q6- Specification
 Q7- Good Manufacturing Practice
 Q8- Pharmaceutical Development
 Q9- Quality Risk Management
 Q10- Pharmaceutical Quality System

7. Q1(STABILLITY)(Q1A-Q1F)
 Q1A (R2) - Stability testing of new drug substances
and products.
ICH Q2(R1)
 Validation of Analytical Procedures : Text &
Methodology

8. ICH Q3A
 Provide guidance for registration application on the content &
qualification of impurities in new drug substance produced by
chemical synthesis & not previously registered in a region state.
 Impurities can be classified as the following categories :
1. Organic impurities 2. Inorganic Impurities 3. Residual solvent

9. ICHQ4B RegulatoryAcceptance ofAnalytical
Procedure &Acceptance Criteria (RAAPAC)
 Effective way to raise & resolve issue that might
impact both industry & regulators.
 A saving in time and Effort.
ICHQ5C Quality of Biotechnological Products :
 Purpose : Guidance to applicants regarding the type
of stability studies that should provide in support of
marketing applications.
 The document dosen’t cover antibiotics, allergic
extracts, heparins, vitamins, or whole blood.

10. ICHQ6A
 Test Procedure & Acceptance Criteria for New Drug
Substance & New Drug Product :
 It provides guidance on the setting & justification of
acceptance criteria & the selection of test procedure
for new drug substance of synthetic chemical origin ,
and new drug product produced from them, which
have not been registered previously in US, EU or
Japan.

11. ICHQ7AGuidance forActive Pharmaceutical
Ingredient :
 Provide guidance regarding GMP for the
manufacturing of API under an appropriate
system for managing quality.
 Distribution of APIs and related control
 Vaccines are not included.
ICHQ8(R1) Pharmaceutical Development :
 Defining the target product profile as it related Q, S,
& E.
 Identifying Critical Quality Attributes (CQA) of the
drug product to study & control the product Quality.
 Determining the Quality attributes of drug sub. &
Excipients etc. to get desired quality.

12. ICHQ9 Quality Risk Management
 Describes systemic processes for the assessment,
control, communication & review of quality risk.
 Applies over product lifecycle : Development,
Manufacture & Distribution.
 Include principles, methodologies & examples of
tools for quality risk management.
ICHQ10 Pharmaceutical Quality System
 Incorporate the concept behind Q8 & Q9 by
providing a pharmaceutical quality system that can be
implemented through out the product lifecycle.
 Tract & learn product Quality
 Maintain & update models as needed
 Internally verify the process changes are successfully

13. ICHQ11 Development & Manufacture of Drug
Substance
 High level technical guidance relevant to the
design, development & manufacture of drug
substance.
 Provide guidance for drug substance (Q6A &
Q6B)

14. Carcinogenicity Studies (S1A-S1C)
 S1A- Guidance on the need for carcinogenicity
studies of pharmaceuticals.
 S1B- Testing foe carcinogenicity of
pharmaceuticals.
 S1C(R2)- Dose selection for carcinogenicity
studies of pharmaceuticals.
S2-Genotoxicity
 S2(R1)- Guidance on Genotoxicity Testing & Data
Interpretation for pharmaceutical intended for human
use.
 S2A- Guidance of Specific Aspect of regulatory
Genotoxicity Tests for pharmaceuticals.
 S2B- A Standard Battery for Genotoxicity Testing for
pharmaceuticals.

15. S3A-S3B Toxicokinetics & Pharmacokinetics
 S3A -Note for guidance on Toxicokinetics : The
Assessment of systemic Exposure in Toxicity
Studies.
 S3B- Pharmacokinetics : Guidance for Repeated
Dose Tissue Distribution Studies
S4- Duration of Chronic Toxicity Testing in
Animals ( Rodent & Non-Rodent Testing)_
S5- Detection of Toxicity to Reproduction for
Medicinal Products & Toxicity to Male Fertilits.
S6- Preclinical Safety Evaluation of
Biotechnology Derived Pharmaceuticals.

16. S7A- Safety Pharmacology Studies for Human
Pharmaceuticals
S8- Immunotoxicity Studies for Human Pharmaceuticals
S9- Nonclicinal Evaluation forAnticancer
Pharmaceuticals
S10- Guidelines-Photo Safety Evaluation of
Pharmaceuticals
S7B- Nonclinical Evaluation of the potential for delayed
ventricular repolarization (QT interval prolongation) by
human pharmaceuticals.
S11- For nonclinical safety testing in support of
development of prdiatric medicines.