Summary To Guidelines By ICH Stability Storage In Drug Development


The International Council on Harmonisation (ICH) is a project which encompasses several regulatory bodies from around the world. It is concerned with the registration of pharmaceuticals for human use, and the technical requirements which accompany it.

In this blog, we delve deeper into the ICH guidelines themselves for stability storage in drug development. These guidelines have been compiled by experts from across the pharmaceutical sector, who meet under the guise of the ICH to discuss technical and scientific pharmaceutical product registration aspects.

Before we lay out the ICH recommended storage conditions, let’s recap on the purpose of the ICH guidelines. They are intended to reduce duplicate testing needing to be carried out when new medicine is researched, and therefore foster greater harmonisation across the pharmaceutical sector. This can make setting requirements and technical guidelines for product registration much easier. It all adds up to a more ecomonical use of our previous human, animal and material resources, and can cut down the delay of important new medicines coming to market. While ICH recommended storage conditions can be a time and resource saver, they are designed to uphold essential safety and quality standards.

ICH recommended storage conditions are as follows:

– 0°C – this ultra-low temperature is generally used for biological samples such as serum and DNA.

– 0°C – this temperature is advisable for biologics, as well as reference and retains standards.

2-8°C Refrigerated – this is used for trial batches and active pharmaceutical ingredients (API) which are in long term storage, as well as reference standards, retain samples, several biologics and injectables.

25°C/60% RH – this is used for storage and medical devices, be they bulk, heritage or retain, as well as long term storage of DNA with the intention of future use.

30°C/65% RH – this temperature is used for the storage of medical and pharmaceutical devices, either intermediate or long term.

30°C/75% RH – usually for trial batches of products which are planned to be distributed in locations with humid or hot climates.

40°C/75% RH – for products which require accelerated conditions, and usually stored for a maximum of six months.

It should be remembered that these ICH guidelines represent a core stability data package which is intended for new drugs and substances. But when there is scientific justification for using an alternative approach, they do not necessarily need to be followed. There are other practical situations, and nuances of different materials, which may also require testing and storage to be carried outside of these guidelines.

Here at Roylance Pharma, our ICH stability storage offering can provide all the conditions described in the ICH recommended storage guidelines above. This applies to the four main climatic zones across the world, as well as customised conditions which may be required by the client. We can assist with the incorporation of studies into stability at various life cycle stages of a drug, encompassing many different trial sizes.

To discuss your requirements with a member of our team today, call us on +(44) 800 368 8499