Pharma Industry Guidelines Quality Assurance

ICH STABILITY ZONES

PharmaState Blog

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31/08/2017

Four climatic zones can be distinguished for the purpose of worldwide stability as follows:

Zone	Type of Climate
Zone I	Temperate zone
Zone II	Mediterranean/subtropical zone
Zone III	Hot dry zone
Zone IVa	Hot humid/tropical zone
Zone IVb	ASEAN testing conditions hot/higher humidity

LONG TERM TESTING CONDITIONS

Climatic Zone	Temperature	Humidity	Minimum Duration
Zone I	21ºC ± 2ºC	45% RH ± 5% RH	12 Months
Zone II	25ºC ± 2ºC	60% RH ± 5% RH	12 Months
Zone III	30ºC ± 2ºC	35% RH ± 5% RH	12 Months
Zone IV	30ºC ± 2ºC	65% RH ± 5% RH	12 Months
Zone IVb	30ºC ± 2ºC	75% RH ± 5% RH	12 Months
Refrigerated	5ºC ± 3ºC	No Humidity	12 Months
Frozen	-15ºC ± 5ºC	No Humidity	12 Months

ACCELERATED AND INTERMEDIATE TESTING CONDITIONS

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

FIND MORE AT…

Reference links

http://www.pharmatutor.org/articles/ich-guidlines-stability-data-review

http://www.google.co.in/url?url=http://vichsec.org/outreach-forum/index.php%3Foption%3Dcom_attachments%26view%3Dattachments%26task%3Dattachment%26id%3D1293&rct=j&frm=1&q=&esrc=s&sa=U&ved=0ahUKEwigrKHT4uvVAhVFrY8KHXyJC7o4ChAWCDkwBw&usg=AFQjCNHruP0KAD5lv1W2hjAfoS86VR2NxQ

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ICH stability zones

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