ICH Requirements for Pharmaceutical

ICH refers to The International Council for Harmonisation, which regulates the Technical Requirements for Pharmaceuticals for Human Use. The ICH was founded in 1990 with the aim to internationally harmonise the regulatory authorities and pharmaceutical industries of Europe, Japan and the United States.

From its inception, the ICH has contributed to advancing public health through:

  • Developing and manufacturing new medicines
  • Preventing unnecessary duplication of clinical trials and clinical evaluations
  • Supervising and registering new medicines
  • Reducing unnecessary animal testing without compromising safety and effectiveness

The ICH has achieved these goals by implementing Technical Guidelines to be followed by the appropriate regulatory authorities.

Q1 Scientific is concerned with the differing Climatic Zones for Stability Studies, as determined by the ICH. Stability studies are placed in different storage conditions with varying temperature and humidity, depending on the climatic conditions of the country in which a new drug substance, or product will be sold. Drugs must be placed within these conditions to apply for registration within the regions of Europe, Japan and the United States.

Stability testing is required to provide evidence on how the quality of a drug varies while under the influence of environmental factors of temperature, humidity, and in some instances, light. Stability testing is also used to establish recommended storage conditions for samples, and a suitable shelf life for products.

Throughout the world, there are 5 different ICH Stability Zones:

Climatic Zone Type of Climate Long term Stability Testing Recommended Conditions
Zone I Temperate 21°C/45%RH
Zone II Mediterranean/Subtropical 25°C/60%RH
Zone III Hot, Dry 30°C/35%RH
Zone IVa Hot Humid/ Tropical 30°C/65%RH
Zone IVb Hot/ Higher Humidity 30°C/75%RH
Map showing ICH conditions in different parts of the world
World map illustration of ICH conditions

 

 

 

 

 

 

 

 

 

 

 

Q1 Scientific has capacity to cater for all climatic zones, ranging from -80°C to 40°C / 75%RH. Long-term testing is generally carried out at 25°C/60%RH, for a minimum of 12 months, while accelerated testing is carried out at 40°C/75%RH for a minimum of 6 months. Testing at an intermediate condition (30°C/65%RH) may also be advisable.

Can we help you?

Contact us today to find out more about how we can help you with your stability storage or call +353 51 355 977.

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If you are reading this article, then you may also be interested in our new webinar series. Following feedback from clients, we have recently curated a series of webinars designed for those working in the pharmaceutical, medical device and life sciences sectors with responsibility for designing and managing stability studies. If would like to gain some key insights into stability study design see our upcoming webinar series.