Why Stability Testing is So much Important (Climatic Zone & Conditions)?
As per STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
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|
|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.
Azerbaijan, china, Georgia, Iran,
Israel, Japan, Kazakhstan,
Kirghizia, Korea, Lebanon, Nepal,
Syria, Tadzhikistan, turkey,
|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,
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.
|Australia, new Zealand.||figi. society islands, Marshall islands, new Caledonia,
Papua-new guinea, Samoa, Tonga.