ICH guidelines for stability studies of different formulation and active pharmaceuticals. physical, chemical, microbial, toxicological therapeutic stability studies. accelerated and intermediate, long term stability studies by following the stability studies we can predict the expiry period and half life of product and avoid the toxic effect of the unstable product

1. ICH STABILITY GUIDELINES FOR BIOLOGICAL PRODUCTS
Submitted by
A. Sreedhar Reddy
M-Pharmacy
Deportment of pharmaceutics
Sri Venkateshwara university college of
pharmaceutical science

2. DEFINITION:
Drug stability means the ability of pharmaceutical dosage form to
maintain physical, chemical, therapeutic and microbial properties during the time of
storage and usage by patient
DRUG STABILITY

3. CHEMICAL STABILITY: Each active ingredient retains its chmical integrity and labelled
potency with in the specific limit.
Physical stability: The physical stability properties includes
appearance,palatability,uniformity,dissolution and suspend ability are retained.
Microbial stability: Sterility or resistance to microbial growth is retained according to specified
requirement.
Therapeutic stability: Therapeutic activity remains unchanged.
Toxicological stability: No, significant increase in toxicity occurs.
TYPES OF STABILITY

4. The international conference on harmonization of technical requirements for
registration of pharmaceuticals for human use is a unique in brinking together the
regulatory authorities and pharmaceutical industry.
MISSION:
1. To achieve greater harmonization.
2. To insure that safe effective and high quality medicine are produced and registered in
most efficient manner
ICH

5. ICH GUIDELINES
ICH GUIDELINES TITLE
Q1A Stability testing of new drug substances or products.
Q1B Photo stability testing of new drug substance or products.
Q1C Stability testing for new dosage forms.
Q1D Bracketing and matrixing designs for stability testing of
drug substances or products.
Q1E Evaluation of stability data.
Q1F Sability data package for registration applicationin
climatic zones III and IV.

6. 1. Stress testing
2. Selection of batches
3. Container closer system
4. Specification
5. Test frequency
6. Storage conditions
7. Stability commitment
8. Evaluation
9. Statement or labelling
STABILITY TESTING OF API’S

7. Stress testing :
 Carried out in a single batch and it includes the effect of temperature,humidity where
appropriate oxidation and photolysis on drug substance.
 Scope: This guideline helps to identify the likely degradation products to establish degradation
pathway and intrinsic stability of the molecule.
Selection of batches:
 At least three primary batches of the drug substance should be selected.
 The quality should be representative to quality of the material used for production scale.

8. Container closure system:
Stability study conducted on the drug substances packed in a container closure system
that is same or stimulate packaging proposed for storage and distribution.
Specification:
These guidelines states that the list test, references to analytical procedures and
proposed acceptance criteria.

9. Test frequency:
For long term stability studies:
year 1:every 3 months
year 2:every 6 months
subsequent years : annually
At accelerate storage conditions:(6 months study) minimum 3 points including t0 and
final.
Example :0(initial) 3 6(final)
At intermediate storage conditions(12 months study)
Example :0(initial) 6 9 12(final)

10. general case:
study
Storageconditions
Minimumtime periodcoveredby dataat submission
Storage conditions:
study Storage conditions Minimum time
period covered by
data at submission
Long term
(ambient)
25˚C±2°C
60%RH±5%RH
12 months
Intermediate
(controlled)
30°C±2°C
65%RH±5%
6 months
Accelerated 40°C±2°C
75%RH±5%
6 months

11. STORAGE IN REFRIGERATOR:
STUDY STORAGE CONDITIONS MINIMUM TIME PERIOD
COVERED BY DATA AT
SUBMISSION
LONG TERM 5°C ± 3°C 12 MONTHS
ACCELERATED 25°C ± 2°C
60%RH ± 5%RH
6 MONTHS
STORAGE IN FREEZER
STUDY STORAGE CONDITION MINIMUM TIME PERIOD
COVERED BY DATA AT
SUBMISSION
LONG TERM -20°C ± 5° C 12 MONTHS

12. If submission includes data from stability studies on atleast three production batches.
If submission includes data from stability studies on fewer than three production batches.
If submission does not include stability data on studies on production batches.
Evaluation :
The purpose of stability study is to establish re-test period(DS) and shelf life(DP),For future
batches on evaluation of results obtained from chemical, physical, microbial and biological tests.
STABILITY COMMITMENT

13. A storage statement established for labelling in relevant national or regional
requirements.
Should be established based on the stability evaluation of the drug substances.
Termed such as “Ambient conditions” or “room temperature” should be avoided.
Reset data for DS and expiry date for DP should be displayed on the container label if
appropriate
STATEMENTOR LABELLING