Ich Guidlines Stability Data Review PDF

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Home (/) » ICH GUIDELINES OF STABILITY DATA: A REVIEW
ICH GUIDELINES OF STABILITY
DATA: A REVIEW
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About Authors:
Kambham Venkateswarlu
Final Year Graduate Student
Sri Lakshmi Narasimha College of Pharmacy,
Palluru, Chittoor-517132, Andhra Pradesh, India.
k.v.reddy9441701016@gmail.com
ABSTRACT: TOP
The International Conference on Harmonization of technical
requirements of pharmaceuticals for human use was
established in 1990 as a tripartite venture representing
regulatory bodies and research based industry. The major
aim of ICH is to provide a forum for constructive discussion
on the real and perceived differences in technical
requirements for the registration of new chemical entities.
Other objectives are: To achieve greater harmonization in
the interpretation and application of technical guidelines for
the registration of new active substances or products
obtained by biotechnology by its members; to improve the
efficiency of global drug development; to reduce redundant
studies; and to improve pharmacovigilance activities and
quality assurance.
REFERENCE ID: PHARMATUTOR-ART-1644
INTRODUCTION:
The co-sponsors of ICH are : The European Commission and
the European federation of Pharmaceutical Industries
Associations [EFPIA]; The Japanese Ministry of Health,
Labour and Welfare [JMHLW] and the Japan Pharmaceutical
Manufacturers Association [JPMA], and the United States
Food and Drug Administration [FDA] and the Pharmaceutical
Research and Manufacturers of America [PhRMA]. These six
cosponsors are the voting members of the ICH Steering
Committee. ICH thus represents 17 countries comprising
15% of the world’s population and accounting for 90% of the
US $ 320 billion global pharmaceutical sales of the year
2000. ICH regulatory authorities are among the first to
evaluate new chemical entities and new products obtained
from biotechnology.
OBJECTIVE OF THE GUIDELINES:

* Establishment of a single set of global specifications for
new drug substances and products.
* Guidance on the setting and justification of acceptance

criteria and the selection of the test procedures.
BACKGROUND:
A specification is defined as a list of tests, references to TOP
analytical procedures and appropriate acceptance criteria
which are numerical limits, ranges or other criteria for the
tests described.
SCOPE OF THE GUIDELINES:
The quality of the drug substances and product is
determined by their:
* Design
* Development
* In-process control
* GMP controls
* Process validation
The guidelines cover:

* Solid dosage forms
* Liquid dosage forms
* Parenterals (small and large volume)
GENERAL CONCEPTS PERIODIC / SKIP TESTING:

Performance of specified tests at release on pre-selected
batches and at pre determined intervals. This less than full
schedule testing should be justified and presented to the
regulatory authority prior to implementation.
Examples for solid dosage forms:

* Dissolution
* Residual solvents
* Microbial testing
This concept may be implemented post-approval in

accordance with GMP, if sufficient data are available.
PHARMACOPOEIA TESTS AND ACCEPTANCE CRITERIA:

Whenever appropriate pharmacopoeia methods should be
utilized. A harmonized specification is possible only if the
procedure and acceptance criteria defined are acceptable to
regulatory authorities in all regions. The full utility of this
guideline is dependent on the successful completion of
harmonisation of pharmacopoeial procedures for several
attributes commonly considered in the specification for new
drug substances and products.
GUIDELINES:
Specifications: Definition and Justification
* Lists of tests
* Reference to analytical procedures
* In process tests
* Periodic tests
* Other tests not conducted on a batch to batch basis.
Justification should refer to:

TOP
* Relevant development data
* Pharmacopoeial standards
* Test data of batches used in toxicology and clinical

studies
* Results from accelerated and long term stability studies.
* Reasonable range of expected analytical and

manufacturing variability.
STORAGE CONDITIONS: [STABILITY]
General case:
For the general case, the recommended long-term and
accelerated storage conditions for Climatic Zones III and IV
are shown below
Study storage condition minimum time period covered by

data at submission:
* Long-term 300C ± 20C / 65% RH ± 5% RH 12 Months.
* Accelerated 400C ± 20C / 75% RH ± 5% RH 6 Months.
No intermediate storage condition for stability studies is

recommended for Climatic Zone III and IV. Therefore, the
intermediate storage condition is not relevant, when the
principle of test period or shelf life extrapolation described
in Q1E are applied.
Aqueous based drug products packaged in semi-permeable

containers:
Aqueous based drug products packaged in semi-permeable
containers, the recommended long term and accelerated
storage conditions for Climatic Zone III and IV are given
below
* Long-term 300C ± 20C / 35% RH ± 5% RH 12 Months.
* Accelerated 400C ± 20C / not more than 25% RH ± 5% RH

6 Months.
The ratio of water loss rates at a given temperature is

calculated by the general formula:
(100 – Reference % RH) / (100 – Alternative % RH)
Alternative relative humidity ratio of water loss rates at a

given temperature:
* 65% RH 35% RH 1.9
* 75% RH 25% RH 3.0
Additional considerations:
If it cannot be demonstrated that the drug substance or drug
product will remain within its acceptance criteria when
stored at 300C ± 20C / 35% RH ± 5% RH for the duration of
the proposed retest period or shelf life, the following options
should be considered:
1) Retest period or shelf li8fe
2) A more protective container closure system
3) Cautionary statements in the labelling
TOP
Tablet coated or uncoated, hard capsules:
Disintegration:
Highly soluble throughout physiological pH range. Solubility
at 370C ± 0.50C, dose + solubility < 250 ml, pH 1.2, 4.0, 6.8.
Rapidly dissolving drugs:
* Dissolution > 80 % in 15 minutes at pH 1.2, 4.2, 6.8.
* Relationship between disintegration and dissolution

respectively disintegration more discriminating than
dissolution.
Hardness / friability: If critical impact on drug quality

acceptance criteria should be established.
Water content: If appropriate preferred Karl Fischer

Titration, loss on drying may be acceptable.
Microbial limits:
It is advisable to test the drug product unless its
components are tested before manufacture and the
manufacturing process is known not to carry significant risk
of microbial contamination. Skip testing may be appropriate.
Oral liquids:
* Based on antimicrobial preservative content
* Based on antioxidant preservative content
Parenteral Drug Products:

* Uniformity of dosage units
* Weight variation fill volume
* Uniformity of fill according to pharmacopoeial procedure
* STERILITY:
- Endotoxins Limulus Amoebocyte Test
- Pyrogens
CONCLUSION:
An ICH guideline gives a stability data information (like
temperature, RH at which conditions products are going to
be stored) for all pharmaceutical products at different
climatic conditions.
REFERENCES:
1. Schumacher, P. “ Aktuelle Fragen Zur Haltbarkeit
Arzneimitteln [ Current Question on Drug Stability]”
pharmazeutische Zeitung, 119: 321- 324, 1974.
2. Grimm, W. “Storage Conditions for Stability Testing –
Long Term Testing And Stress tests”. Drug made in
Germany, 28: 196-202, 1985 (Part I) and 29: 39-47, 1986
(Part II).
3. Dietz, R., Feilner, K., Gersty, F., Grimm, W. “ Drug Stability
Testing-classification of countries according to climatic
zone”. Drugs Made In Germany, 36: 99-103, 1993.
4. Grimm, W. “Extension of the International Conference on
harmonization Tripartite Guidelines for Stability Testing of
New Drug Substances and products to Countries of Climatic
Zones III and IV” Drug development and Industrial
Pharmacy, 24: 313-325, 1998. TOP
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stability guideline ich

review article on ich guidelines

ich guidelines for elemental impurities

top 100 generic pharmaceutical companies

REFERENCE ID: PHARMATUTOR-ART-1644

OBJECTIVE OF THE GUIDELINES:

* Guidance on the setting and justification of acceptance

The guidelines cover:

* Liquid dosage forms

* Parenterals (small and large volume)

GENERAL CONCEPTS PERIODIC / SKIP TESTING:

Examples for solid dosage forms:

This concept may be implemented post-approval in

PHARMACOPOEIA TESTS AND ACCEPTANCE CRITERIA:

* Reference to analytical procedures

* Other tests not conducted on a batch to batch basis.

Justification should refer to:

* Test data of batches used in toxicology and clinical

* Results from accelerated and long term stability studies.

* Reasonable range of expected analytical and

STORAGE CONDITIONS: [STABILITY]

Study storage condition minimum time period covered by

* Accelerated 400C ± 20C / 75% RH ± 5% RH 6 Months.

No intermediate storage condition for stability studies is

Aqueous based drug products packaged in semi-permeable

* Accelerated 400C ± 20C / not more than 25% RH ± 5% RH

The ratio of water loss rates at a given temperature is

Alternative relative humidity ratio of water loss rates at a

* 75% RH 25% RH 3.0

* Relationship between disintegration and dissolution

Hardness / friability: If critical impact on drug quality

Water content: If appropriate preferred Karl Fischer

* Based on antioxidant preservative content

Parenteral Drug Products:

SUBMIT YOUR ARTICLE/PROJECT AT

FIND OUT MORE ARTICLES (http://www.pharmatutor.org/articles)

Adis Pharmacovigilance is the expert solution

Review Articles (/taxonomy/term/2989)

Andhra Pradesh (/taxonomy/term/2832)

Walk in Senior Manager

Production, QA, Multiple Jobs

A mini review on nanosuspension drug delivery system :

Enter your email address:

Do Not Forget to Verify

(Click on Subscription link

Sales & Marketing

Course wise Alerts

NOVEL DRUG DELIVERY

Review on: THE

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Copyright © 2008-2020, PharmaTutor Edu Labs

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