Global climatic zone divisions for stability studies on pharmaceuticals

World Climatic zones

World Climatic zones

A pharmaceutical manufacturer has manufacturing facilities in single or multiple locations. However, the product can be consumed by patients at locations which can be spread within the country or even in markets across the world. It is natural to expect variations in climatic conditions in different locations so the question arises that will the shelf life be same or different in domestic and international markets.

For the purpose of stability testing ICH recommended the world climate into four zones, namely, I,II,III ad IV. The zone IV was subsequently split into zone IVa and IVb. The temperature and long term testing conditions for the four zones are mentioned below. The degradation of the product will be faster in higher category zones so the shelf life will be shorter in such areas.

Climate Zone  Temperature  Humidity
I-Temperate 21^0C +/- 2^0 C 45% +/- 5%RH
II-Mediterranean 25^0 C +/- 2^0C 60% +/-5% RH
III-Hot/dry 30^0 C +/- 2^0C 35% +/- 5% RH
IV-a Hot/ Humid 30^0C +/- 2^0C 65% +/- 5% RH
IV-b Hotter / Greater Humidity 30^0C +/- 2^0C 75% +/- 5% RH

 

The zone classification is based on the temperature and humidity conditions prevailing in the location. The higher the temperature and humidity the greater are the chances of product degradation In terms of physical appearance fall in assay value, formation of degradation products or increased micro organisms growth. In addition the container- closure system can also contribute to such changes.

Stability data assumes importance at all stages of the drug cycle from manufacture till consumption. The key objective is that the manufacturer should ensure that the formulation does not lose its potency or result in degradation byproducts that can do more harm than good to the consumer.

Accelerated testing is mainly resorted to by majority of manufacturers at their own facilities or through services provided by accredited testing laboratories. Such studies are done at 40^0C +/- 2^0C and 75 % +/- 5% RH for a minimum duration of 6 months. The shelf life estimate should be confirmed with parallel long-term testing for minimum 12 months duration. Accelerated stability testing can help predict degradation products that can be expected under long-term storage and to modify the formulation at time of manufacture to prevent such compound formation over the storage period and till final consumption. Before releasing the products the manufacturer should have the stability studies carried out and assign the expiry date accordingly.

About Dr. Deepak Bhanot

Dr Deepak Bhanot is a seasoned professional having nearly 30 years expertise beginning from sales and product support of analytical instruments. After completing his graduation and post graduation from Delhi University and IIT Delhi he went on to Loughborough University of Technology, UK for doctorate research in analytical chemistry. His mission is to develop training programs on analytical techniques and share his experiences with broad spectrum of users ranging from professionals engaged in analytical development and research as well as young enthusiasts fresh from academics who wish to embark upon a career in analytical industry.

Comments

  1. Hi doc,
    I have carefully read this wonderful article and I truly believe everything you sustain !

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