ICH GUIDELINES- process of harmonization, brief overview of QSEM

INTERNATIONAL COUNCIL FOR
HARMONIZATION GUIDELINES
• It formerly known as International Conference on
harmonization.
• Mission: to bring together the regulatory authorities and
pharmaceutical industry to achieve worldwide
harmonization to ensure that safe, effective and high-quality
medicines are developed and registered in the most
resource-efficient manner.
Mrs. U. P. Mahale (Pharmacognosy)

ICH GIUDELINE
OBJECTIVE:
▪ To improve efficiency of new drug development and registration
processes.
▪ To make recommendations in order to achieve harmonization in
the application of technical guideline and requirements for
pharmaceutical product registrations.
▪ To maintain a forum for a constructive dialogue on scientific
issues between regulatory authorities and the pharmaceutical
industry on the harmonization of the technical requirements for
pharmaceutical products.
▪ To monitor and update harmonized technical requirements in
order to support and accept R & D approaches.

▪ Continuous updating of guidelines by facilitating the adoption of
new or improved technical R 7& D approaches.
▪ To encourage the integration and implementation of common
standards.
▪ To develop a policy for the ICH Medical Dictionary for
regulatory activities. That is a standardized dictionary which
facilitates the sharing of regulatory information internationally
for medicinal products used by humans.
▪ To improve public health, prevent duplication of clinical trials in
humans and minimize the use of animal testing without
compromising safety and effectiveness.

PARTICIPANTS
• Founder member: European Union, Japan and USA
• There are Six (founding members) co-sponsors are voting members of
the ICH steering Committee or assembly.
1. European Commission (EC)
2. European Federation of Pharmaceutical Industries Associations
(EFPIA)
3. Japanese Ministry of Health, Labour and Welfare (JMHLW)
4. Japan Pharmaceutical Manufacturers Association (JPMA)
5. United States Food and Drug Administration (FDA)
6. Pharmaceutical Research and Manufacturers of America (PhRMA)

• Standing Regulatory members included as ICH members
1. Health Canada
2. Swissmedic
3. ANVISA (BRAZILIAN HEALTH REGULATORY AGENCY)
4. Brazil
5. Ministry of Food and Drug Safety (MFDS)
6. Republic of Korea
7. International Generic and Biosimilar Medicines Association
(IGBA)
8. World Self-Medication Industry (WSMI)
9. Biotechnology Innovation Organisation (BIO)

• The International federation of Pharmaceutical
Manufacturers Associations (IFPMA) provides the ICH
secretariat.
• WHO, Canada and the European Free Trade Association
(EFTA) hold standing observer status in ICH and steering
Committee.
• Standing Observers: CDSCO, India and other regulatory
agencies

ORGANISATION OF ICH
Observers
Non ICH
Parties
ICH Parties
Assembly
MedDRA MC
Management
committee
ICH Working
groups
Quality Safety Efficacy
Multi-
disciplinary
ICH
Secretariat
ICH
Secretariat
1. ASSEMBLY
2. MANAGEMENT COMMITTEE
3. MED DRA MANAGEMENT COMMITTEE
4. ICH SECRETARIAT AND COORDINATORS
5. ICH WORKING GROUP

PROCESS OF
HARMONIZATION
implementation
Adoption of ICH guidelines
Regulatory consultation and
discussion
Endorsement by the assembly
Consensus on Draft technical
document
Selection of new topic for
harmonization: Concept paper
1. Selection of harmonization topic
2. Scientific discussion
3. Production of harmonized ICH Guideline
4. Regulatory implementation

ICH GUIDELINES
• Q – Quality guidelines: stability studies, guidelines defining
relevant thresholds for impurities testing and GMP
• S – Safety guidelines: Carcinogenicity, genotoxicity,
toxicokinetic & pharmacokinetics, reprotoxicity &
immunotoxicity
• E – Efficacy guidelines: concerned with design, conduct,
safety and reporting of clinical trials.
• M – Multidisciplinary guidelines: med DRA, ESTEI, CTD

BRIEF OVERVIEW OF ICH QSEM
GUIDELINES
• ICH guideline for stability testing of new drug substances and products:
• Climatic zones
• Stability testing guideline:
1. Drug substance (storage condition)
2. Drug product –selection of batches and container closure system
a. Bracketing
b. Matrixing
c. Specification
3. Testing frequency
4. Storage condition
5. Evaluation
6. Labeling
7. Photostability testing

Storage condition
General case:
1. Long term studies (12 months) - 25℃ & 60% RH or 30℃ & 65% RH
2. Intermediate studies (6 months) - 30℃ & 65% RH
3. Accelerated studies (6 months) – 40℃ & 75%
Drug products packed in impermeable containers
• Stability studies for such products can be conducted under any controlled or ambient
humidity condition.
Drug products packed in semi-permeable containers
• Should be evaluated for potential water loss in addition to physical, chemical, biological and
microbiological stability.
• They should withstand low RH environments.
Drug products stored in a Refrigerator
• Long term - 5℃ ± 3℃ •Accelerated - 25℃ & 60% RH
Drug products stored in a Freezer
• Long term – (-20)℃ ± 3℃
Mrs. U. P. Mahale
(Pharmacognosy)

Testing Frequency
• Proposed shelf life for products at least 12 months,
• Generaltesting (long term storage condition): every 3
months first year, every 6 months second year, then
annually through proposed test period
• Accelerated storage conditions – a min of 3 time points
(0,3,6 months), including the initial and final time points
from a 6 month study, is recommended.
• Intermediate storage conditions – a min of 4 time points
(0,6,9,12 months) , including the initial and final time
points from a 12 month study, is recommended.

Storage condition
• Significant change:
1. Failure to meet the acceptance criteria for potency when
using biological or immunological procedure.
2. Any degradation products exceeding its acceptance
criterion.
3. Failure to meet the acceptance criteria for appearance,
physical attributes and functionality test (e.g. colour etc)
4. Failure to meet the acceptance criterion for pH.
5. Failure to meet the acceptance criteria for dissolution for
12 dosage units.

Evaluation
• It included stability data using systematic approach of physical,
chemical, biological and microbiological tests including particular
attributes of dosage form.
• Stability study purpose: to establish, based on testing a minimum of
three batches of the drug product, shelf life and label storage
instructions applicable to all future batches of drug products.

Labeling
• The data may show some little degradation, that it is
apparent from looking at the data that the requested re-test
period is granted. A storage statement should be established
for the labelling in accordance with the national or regional
requirements.
• Where applicable, specific instructions should be provided,
particularly for drug products that cannot tolerate freezing.
E.g. ambient conditions or room temperature etc.

Photostability testing
• As per ICH Q1B guideline, light testing is an integral part of
stress testing..
• A systematic approach to photostability testing is recommended
covering, as appropriate, studies such as:
1. Tests on the active substance
2. Test on the exposed product outside of the immediate pack
and if necessary
3. Test on the product in the immediate pack and if necessary
4. Test on the product in the marketing pack.
Mrs. U. P. Mahale
(Pharmacognosy)

Photostability testing
• IT refers to the testing of a drug product to determine
whether the appropriate light exposure does not result into
unacceptable changes in the dosage form.
• Photo stability deals with the effect of light on stability of
pharmaceutical products.
• Data should be provided on at least 3 primary batches of the
drug product.
• Stability testing should be conducted on the dosage form
packed in the container – closure system proposed for
marketing.

ICH GUIDELINES- process of harmonization, brief overview of QSEM

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