November 29, 2019 by Roylance Pharma
The main background purpose of ICH stability storage comes back to the main focus of what we do here at Roylance Pharma, and of the thinking behind the International Council on Harmonisation, which has put together these recommended storage conditions.
What is the ICH?
The International Council on Harmonisation is a project which represents a collaboration between several regulatory authorities across the world - including in Europe, the United States, and Japan. It is concerned with the technical requirements for pharmaceuticals which are to be registered for human use.
The ICH has provided a forum for these experts from across the pharmaceutical sector to converge in order to discuss pharmaceutical product registration - both the technical and scientific aspects. As the ICH itself states: "Harmonisation is achieved through the development of ICH Guidelines via a process of scientific consensus with regulatory and industry experts working side-by-side."
There are four different Stability Zones set up, according to the specific climates of different regions around the world. These are largely; Stability Zone 1 across North America, Northern Europe, Russia and Japan; Stability Zone 2, in parts of North and South America, Southern Europe, parts of Africa, Asia and Australia; Stability Zone 3, in parts of Africa and the Middle East; and Stability Zone 4, which is mainly areas around the equator.
What is the purpose of ICH stability storage?
Now we have outlined the scope of the ICH itself, let's look at the benefits of its stability storage guidelines. Their main purpose is to reduce, or even eliminate, the need for duplicate testing to be carried out when new medicines are researched and developed. By offering a way to harmonise the manner in which technical guidelines are interpreted, the pathway to product registration can be smoothed in this respect.
But these stability storage guidelines don't only benefit the researchers involved in developing drugs, they also allow us to economise on our use of resources. That goes for the workloads put in by human workers, as well as non-human animal resources, and materials which are used in drug development. What's more, ICH stability storage is crucial in speeding up drug testing and development. Where new medicines are concerned, this can be vital in bringing drugs to market more quickly, to the greater good of the patients who need them.
No cutting corners
Importantly, despite its ability to save both resources and time, ICH stability storage should not be viewed as a short cut which compromises the safety or quality of drugs. On the contrary - it actually promotes the regulatory obligations which are needed to protect public health.
Organisations like us at Roylance Pharma play a huge part in helping pharmaceutical companies to ensure that they are maintaining ICH specifications and meeting ICH standards. From freezer and refrigerated conditions to hot and humid conditions and accelerated conditions; trust us to satisfy ICH guidelines and help to fast track your pharmaceutical development plans. Call us today on +(44) 800 368 8499.