M.Pharm Sem-1 QA 102T

1. Ch.4 Drug Stability
Q.1) Write brief history, aim, objectives, role of ICH.
Which are four basic category of ICH discuss briefly.
• The International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use (ICH)
is unique in bringing together the regulatory authorities
and pharmaceutical industry to discuss scientific and
technical aspects of pharmaceuticals and develop ICH
guidelines.
• The International Council for Harmonisation (ICH), formerly
the International Conference on Harmonisation (ICH) held
the inaugural Assembly meetings on 23 October 2015
establishing ICH as an international association, a legal
entity under Swiss law.
• This step built upon a 25-year track record of successful
delivery of harmonised guidelines for global pharmaceutical
development as well as their regulation, and a longer
standing recognition of the need to harmonise.
• AIM:
• 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 facilitate the adoption of new or improved technical
research and development approaches which update or replace
current practices.
• to make recommendations towards achieving greater
sharmonisation in the interpretation and application of
technical guidelines and requirements for pharmaceutical
product registration and the maintenance of such registrations.

2. • 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 develop policy for the ICH Medical Dictionary for Regulatory
Activities Terminology (MedDRA) whilst ensuring the scientific
and technical maintenance, development and dissemination of
MedDRA as a standardised dictionary which facilitates the
sharing of regulatory information internationally for medicinal
products used by humans.
• Objective:
• The purpose of the Association is to promote public health
through international harmonisation of technical requirements
that contributes to the timely introduction of new medicines
and continued availability of the approved medicines to
patients, to the prevention of unnecessary duplication of
clinical trials in humans, to the development, registration and
manufacturing of safe, effective, and high quality medicines in
an efficient and cost-effective manner, and to the minimisation
of the use of animal testing without compromising safety and
effectiveness.
• Promotion of public health through international
harmonisation that contributes to:
• Prevention of unnecessary duplication of clinical trials and post
market clinical evaluations
• Development and manufacturing of new medicines
Registration and supervision of new medicines
• Role:
• Promote international harmonization of technical
requirements to develop safe, effective, and high
quality medicines.

3. * Reduce the registration cost.
* Promote public health.
* Prevent the duplication of clinical trialsin Humans
* Minimize the animal use without compromising in
the safety, qualitut compromising in the safety,
qualityReduction of unnecessary animal testing without
compromising safety and effectiveness
• – To improve efficiency of new drug development and
registration processes – To promote public health, prevent
duplication of clinical trials in humans and minimize the use of
animal testing without compromising safety and effectiveness.
• ICHguidelines:
The ICH topics are divided into four categories and
ICH topic codes has been given according to these
categories.
1.Qualityguidelines.
2.Safetyguidelines.
3.Efficacyguidelines.
4. Multidisciplinary guidelines.
• Q-Qualityguidelines
It provides guidelines regarding the Harmonization
achievement in quality area, conduct, stability
studies, defining relevant thresholds for impurities
testing & more flexible approach to pharmaceutical
quality based on (GMP) risk management
• S-Safetyguidelines
It provides safety guidelines to uncover potential
risks like carcinogenicity, genotoxicity and
reprotoxicity.
• E-Efficacyguidelines
It is concerned with design, conduct, saftey and
reporting of clinical trials; it also covers novel types
of medicines derived from biotechnological process

4. and the use of pharmacogenitic/genomics
techniques to produce better targeted medicines
• M-Multidisciplinaryguidelines
Includes ICH medical terminology and common
technical document and the development of
electronic standards for the transfer of regulatory
information.
Q.2) Discuss administrative structure of ICH with
the role of each post/group.
Structure of ICH :
1. ICH Assembly
2. ICH Management Committee
3. MedDRA Management Committee
4. ICH Secretaria
• The ICH Assembly works in bringing together all
Members and Observers of the ICH Association as the
overarching governing body of ICH. It takes decisions on
particular matters such as on the adoption of ICH
Guidelines, admission of new Members and Observers. and
the ICH Association’s work plans and budget. Member
representatives appointed by the Assembly are supported
by ICH Coordinators who represent each Member to the
ICH Secretariat on a daily basis.
• The ICH Management Committee (MC) is that body
which supervises the operational aspects of ICH on
behalf of all Members, including administrative and
financial matters and oversight of the Working Groups
• The MedDRA Management Committee (MC) has
responsibility for providing direction of MedDRA, ICH’s
standardised medical terminology. The MedDRA MC is
responsible for managing, supporting, and facilitating the
maintenance, development, and dissemination of MedDRA
• ICH’s standardised medical terminology. The MedDMC is
responsible for managing, supporting, and facilitating the
maintenance, development, and

5. • The ICH Secretariat is responsible for day-to-day
management of ICH, coordinating ICH activities as well as
providing support to the Assembly, the MC and Working
Groups. The ICH Secretariat also provides support to the
MedDRA MC. The ICH Secretariat is located in Geneva,
Switzerland.
Q.3) Importance of stability testing. (4)
Stability testing is necessary due to following reasons.
• Product instability may lead to under medication due to lowering
of active drug concentration in dosage form.
• Drug decomposition leads to formation of toxic products.
• Instability leads to changes in physical appearance.
• During the marketing from one place to another during the
transportation the drug has the
• During the marketing from one place to another during the
transportation has the compatibility to change its physical
properties.
•  Instability may be due to changing in physical
appearance through the principles of
• Instability may be due to changing in physical appearance
through the principles of kinetics are used in predicting the
stability of drug there different between kinetics and stability
study
• Chemical degradation of the product leads to lowering the
concentration of drug in the dosage form.
• Toxic products may be formed due to chemical degradation of
the active ingredient.
Q.4) write a note on Q1B or explain regulatory guideline for
photo stability according to ICH. (5 OR 6)
• Stability is officially defined as time period in which the
drug product retains the same properties and characteristics
that it possessed it at the time of its manufacturing. The
stability of drug product is always expressed in terms of its
shelf life.
• The Photostability studies are carried out to
demonstrate that the appropriate light exposure does not
results into unacceptable changes in dosage form. It deals

6. with the effect of light on stability of pharmaceutical
substances/product.
• Light can influence the active principle in a drug
formulation, as well as the final product or package. In this
manner, the photostability deals with the effect of the light
(photons) on stability of pharmaceutical substances.
• A systematic approach to photostability testing is
recommended covering, as appropriate, studies such as:
• i) Tests on the drug substance;
ii) Tests on the exposed drug product outside of the
immediate pack;
and if necessary ;
iii) Tests on the drug product in the immediate pack;
and if necessary ;
iv) Tests on the drug product in the marketing pack.
• The extent of drug product testing should be established by
assessing whether or not acceptable change has occurred at
the end of the light exposure testing as described in the
Decision Flow Chart for Photostability Testing of Drug
Products. Acceptable change is change within limits justified
by the applicant.
• The formal labeling requirements for photolabile drug
substances and drug products are established by
national/regional requirements.
REST IS IN Q1B GUIDELINE
Q.5) write a note on ICH Q9. (5)
Q.6) Explain in detail about Q1A. (5)
Q.7) Discuss in detail ICH Q8, Q9, Q10 Guideline (10)
Q.8) Short note on stability testing of new drug substance &
product according to ICH? (4)
Q.9) What are the criteria for selection of batch & testing
frequency for stability testing according to ICH? (4)