The selection of the suitable climatic zone is made according to the guidelines of the International Conference on Harmonization of Technical Requirements of Pharmaceuticals for Human Use Guidelines Q1A(R2) "Stability testing of new drug substances and products" and ICH Q1F "Stability data Package for Registration in Climatic Zones III and IV". Climatic Zones I and II are relevant for registrations in Europe, USA and Japan. For Brazil, for example, stability data must be determined in climate zone IVb. The WHO Stability Guideline covers the requirements for all climate zones. Annex 2, Table 2 of the Guideline describes about 200 countries with their country-specific climatic conditions. Companies must take these into account for long-term storage when approving their products.
The WHO guideline describes the following climate zones:
- Zone I: "temperatures" 21°C/45% RH (relative humidity)
- Zone II: "subtropical" 25°C/60% RH
- Zone III: "hot/dry" 30°C/35% RH
- Zone IVa: "hot/humid" 30°C/65% RH
- Zone IVb: "hot/very humid" 30°C/75% RH
The ICH-Guideline combines climate zones I and II into one and defines them via the worst case condition, i.e. 25°C/60% RH.
Similarly, climate zones III, IVa and IVb can be combined into a worst case condition with 30°C/75% RH. In addition to these two long-term stability programs, we also offer accelerated studies at 40°C/75% RH.
DSI-pharm supports you with the approval of your product. Together, we plan your stability study and support you with analytical expertise using our many years of experience until your product is launched and beyond, in on-going stability studies!
Tentamus Group GmbH was founded in 2011. Tentamus is a global product and safety group with a core presence in Europe, UK, Israel, China, Japan, India and the USA. Accredited and licensed Tentamus Group tests, audits and consults on all products involving the human body (food & feed, pharmaceuticals & medical, agrosciences, cosmetics, agriculture & environment and nutraceutical & supplements). Tentamus Group is represented in over 65 locations worldwide. More than 2,500 highly-trained staff members work in over 2.5 million square feet of laboratory and office spaces. For further information please visit www.tentamus.com.
Tentamus Group GmbH
An der Industriebahn 5
Telefon: +49 (30) 206038-230
Telefax: +49 (30) 206038-190
General Manager Pharma; DSI-pharm
Telefon: +49 (441) 3613265-449