The following guideline is a revised version of the ICH Q1A guideline and defines the stability data package for a new drug substance or drug product that is sufficient for a registration application within the three regions of the EC, Japan, and the United States.

1. STABILITYGUIDELINEQ1A.
Presented by:
Prof.Vedanshu Malviya
P.R.POTE PATIL COLLEGE OF
PHARMACY,AMRAVATI

4.  History of ICH
-After 1950 allopathy began developing in
Europe.
-Met with thalidone accident
-Needed guidelines
-1989WHO conference on drug regulatory
affairs
-1990 birth of ICH Brussels.
Europe ,Japan and US.

5.  Objectives of ICH
To set international standards for
-Quality
-Safety
-Efficacy
of drug substance

6.  Stability guideline Q1A
 STABILITYTESTING OF NEW DRUG
SUBSTANCE AND PRODUCT.

7. GUIDELINES.
1.STRESSTESTING
The stress testing of the drug substance and
product can help to identify
a.Degradation of the product.
b. Establish the degradation pathway
c. Intrinsic stability of the molecule
d.Validate the stability

8. Stress testing should include the effect of
a.Temperature
b. Humidity
c. Oxidation
d.Photolysis
e.pH

9. 2.Selection of batches
- Data from formal stability studies should be
provided on at least 3 primary batches as of
the drug substance.
-The batches should be manufactured to a
minimum of pilot scale by the same synthetic route
and using a method of manufacture and procedure
that simulates the final process to be used for
production batches .

10. 3.Container closure system.
-The stability study should be
conducted on the drug substance
packaged in a container closure system
that is same as or simulate the
packaging proposed for storage and
distribution.

11. 4. Specifications.
-Specifications is a list of test ,reference to
analytical procedure and proposed
acceptance criteria.
-The testing should cover the physical,
chemical ,biological and microbiological
attributes.

12. 5.Testing frequency.
- For a drug substance with a proposed re test
period at least 12 months , the frequency of
testing at the long term storage conditions is 3
months over the first year, every 6 months over
the 2nd year and annually there after through
the proposed re test period.

13. 6.Storage condition .
- In general , a drug substance should be
evaluated under storage condition with
appropriate tolerance that test its thermal
stability and sensitivity to moisture.

15. 8.Evaluation .
-The evaluation of stability information is a
systemic approach which include the evaluation
of results from the physical ,chemical ,
biological and micro biological test .
-The purpose of stability study is to establish
shelf life and labelled storage conditions
applicable to all future batches.

16. 9.Statement / Labelling
- A storage statement should be established
for the labeling in accordance with relevant
national, regional requirements .
-expiration date should be mentioned on
container label.
- A re test date should be displayed on the
container label if appropriate .

17. CONCLUSION:
1. The stability testing ensures production of
safe ,effective,quality medicines.
2. Stability testing provides equality in human
health.

18. THANK YOU