ICH Guidelines:

Climatic Zones
The world has been divided into four climate zones with countries being assigned to the relevant
zones. This is largely the work of W.Grimm (Grimm, 1985) who used the mean kinetic
temperature (MRT) as the basis. The four zones are described in figure.
Classified according to four climatic zones
Designation Climatic Temp. Relative mbar
Condition Humidity
I Moderate 210C 45% 11.2
II Subtropical 250C 60% 19.0
III Hot (dry) 300C 55% 15.0
IV Tropical 300C 70% 30.0

The values are derived from measurement obtained in the various zones during one-year period.
The countries have been assigned to climatic zones as follows (examples).
• Climatic zone-I - Great Britain, Northern Europe, Canada, Russia.
• Climatic zone-II - USA, Japan, Southern Europe (mediterranean region)
• Climatic zone-III - Iran, Iraq, Sudan
• Climatic zone-IV - Brazil, Ghana, Indonesia, Nicaragua, Philippines
As this classification demonstrates, approximately 90% of the global pharmaceutical market lies
in the moderate or subtropical climate zones. This has been used as the basis for deriving
standard storage conditions for climate zones I and II in ICH guideline Q1A :

Standard storage condition in accordance with ICH Q1A (R2) and ICH Q1F
for climate zone I & II Temperature Relative humidity
Long-term studies 250C ± 20C 60% ± 5%
Intermediate conditions 300C ± 20C 65% ± 5%
Accelerated studies 400C ± 20C 75% ± 5%
for climate zones III & IV
Long-term studies 300C ± 20C 65% ± 5%
Accelerated studies 400C ± 20C 75% ± 5%
1. Introduction
1.3 General Principles
• Purpose of stability testing is to provide evidence how quality varies with
time
under influence as
- temperature
- humidity
- light,
• establish re-test period for drug substances
• establish shelf life for drug products
• recommend storage conditions
• Test conditions based on analysis of effects of climatic conditions in the
three
regions of the EC, Japan, USA
• mean kinetic temperature can be derived from climatic data
• world can thereby divided into four climatic zone I-IV
• This guideline addresses climatic zones I and II
• Stability information generated in one of the three regions is mutually
acceptable to
the other two provided:
- information is consistent with this guideline,
- labelling is in accord with national/ regional requirements.
The four Climatic Zones
Climatic Zone
Definition
Climatic Zone Definition Storage
conditions

1 Temperate
climate 21°C/ 45% r.h
2 Subtropical and 25°C/60%r.h.
Mediterranean
climate

3 Hot, dry climate 30°C/35%r.h

4 Hot, humid climate 30°C/70%r.h.

ICH Q1AR2 C 19
Countries of climatic zones I and II
Europe:
EU, Belarus, Bulgaria, Estonia, Hungary, Latvia, Lithuania,
Norway, Rumania,
Russia, Switzerland, Ukraine
America:
USA, Argentina, Bolivia, Chile, Canada, Mexico, Peru, Uruguay
Africa:
Egypt, Algeria, Canary Islands, Libya, Morocco, Namibia, Rwanda,
South
Africa, Tunisia, Zambia, Zimbabwe
Asia:
Japan, Afghanistan, Armenia, Azerbaijan, China, Georgia, Iran,
Israel,
Kazakhstan, Kirghizia, Korea, Lebanon, Nepal, Syria, Tadzhikistan,
Turkey,
Turkmen, Uzbekistan,
Australia,
New Zealand.

2.2.6 Testing Frequency

Long term studies

• first year every three months. 0, 3, 6, 9, 12

• second year every six months: 12, 18, 24
• third year and longer annually: 24, 36, 48, 60
Accelerated studies

• general minimum three time points: 0,3,6 months

• expectation of significant change increases testing adding samples at final
time
point or forth time point: 0, 3, 2x6 or 0, 1, 3, 6 months
Intermediate storage condition studies

Minimum four time points, including initial and final e.g.: 0,6,9,12 months, at
time of
submission 0,6 months
Reduced design

Matrixing or bracketing for reduction of testing frequency if justified

Study Storage condition Minimum time
period at submission
Long term* 25°C ± 2°C/60% ± 5% 12 months
or 30°C ± 2°C/65% ±
5%

Intermediate** 30°C ± 2°C/65% ± 5% 6 mon

Accelerated 40°C ± 2°C/75% ± 5% 6 mon.