Why Stability Testing is So much Important?

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Why Stability Testing is So much Important (Climatic Zone & Conditions)?

 

As per STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
Q1A(R2)& WHO;

The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions.

The choice of test conditions defined in this guideline is based on an analysis of the effects of climatic conditions in the three regions of the EC, Japan and the United States. The mean kinetic temperature in any part of the world can be derived from climatic data, and the world can be divided into four climatic zones, I-IV. This guideline addresses climatic zones I and II. The principle has been established that stability information generated in any one of the three regions of the EC, Japan and the United States would be mutually acceptable to the other two regions, provided the information is consistent with this guideline and the labeling is in accord with national/regional requirements.

Stability Testing Study should be perform as per Climatic zone conditions specified by as per given below;

Sr No         Zone                      Type of Climate
1                 Zone I                    Temperate Zone
2                 Zone II                  Mediterranean/Subtropical Zone
3                 Zone III                 Hot Dry Zone
4                 Zone IVa               Hot Humid/Tropical Zone
5                 Zone IVb               Hot/Higher Humidity

Accelerated and Intermediate Testing Conditions.

Sr. No Climatic Zone Temperature Humidity Minimum Duration
1 Accelerated Ambient 40ºC ± 2ºC 75% RH ± 5% RH 6 Months
2 Accelerated Refrigerated 25ºC ± 2ºC 60% RH ± 5% RH 6 Months
3 Accelerated Frozen 5ºC ± 3ºC No Humidity 6 Months
4 Intermediate 30ºC ± 2ºC 65% RH ± 5% RH 6 Months

Long Term Stability Testing Criteria as per Given Below;

Sr No Zone Temperature Humidity Minimum Duration
1 Zone I 21ºC ± 2ºC RH 45% RH ± 5% 12 Months
2 Zone II 25ºC ± 2ºC RH 60% RH ± 5% 12 Months
3 Zone III 30ºC ± 2ºC 35% RH ± 5% RH 12 Months
4 Zone IVa 30 ± ºC 2ºC 65% RH ± 5% RH 12 Months
5 Zone IVb 30ºC ± 2ºC 75% RH ± 5% RH 12 Months
6  Refrigerated  5 ºC ± 3ºC  No Humidity 12 Months
 7  Frozen  -15 ºC ± 5ºC  No Humidity 12 Months

Classification of countries according to climatic zones

Region zone i and ii countries zone iii and iv countries
Europe all countries
America Argentina, Bolivia, Chile, Canada,

Mexico, Peru, Uruguay, USA

Barbados, Belize, brazil, costa Rica, Dominican republic,

Ecuador, el Salvador, Guatemala, Guyana, haita,

Honduras, Jamaica, Columbia, Cuba, Nicaragua, Dutch

Antilles, panama, Paraguay, Puerto rico, Venezuela. all

of these countries are assigned to cz iv.

Asia Afghanistan, Armenia,

Azerbaijan, china, Georgia, Iran,

Israel, Japan, Kazakhstan,

Kirghizia, Korea, Lebanon, Nepal,

Syria, Tadzhikistan, turkey,

Turkmenia, Uzbekistan

Bahrain, Bangladesh, Hong Kong, India, Indonesia, Iraq

(iii), Jordan (iii), Kampuchea, Qatar, Kuwait, Laos,

Malaysia, Maldives islands, Myanmar, Oman, Pakistan,

Philippines, Saudi Arabia, Singapore, Sri-Lanka, Taiwan,

Thailand, United Arab Emirates, Vietnam, Yemen

Africa Egypt, Algeria, Tunisia, Libya,

morocco, Namibia, Ruanda,

south Africa, tunesia, Zambia,

Zimbabwe.

 

Angola, Ethiopia, Benin, Botswana (iii), burkino faso,

burundi, djibouti, ivory coast, gabon, gambia, ghana,

guinea, cameroon, kenya, longo, liberia, madagascar,

malawi, mali, mauritania, mozambique, niger, nigeria,

senegal, sierra leone, somalia, sudan, tanzania, togo,

Chad (iii), uganda, zaire, central african republic.

Australian/

oceanic

Australia, new Zealand. figi. society islands, Marshall islands, new Caledonia,

Papua-new guinea, Samoa, Tonga.

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