What is ICH?
ICH is the International Council on Harmonisation of technical requirements for Registration of Pharmaceuticals for Human Use.
It is a project that brings together the regulatory authorities of Europe, Japan and the United States.
Experts from the pharmaceutical industry within the three regions come together to discuss scientific and technical aspects of pharmaceutical product registration.
Purpose of ICH Guidelines
The purpose of ICH is to reduce or eliminate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration. By recommending ways to achieve greater harmonisation in the interpretation and application of technical guidelines, ICH aims to make the development and availability of new medicines more efficient while maintaining high standards of quality, safety, and efficacy.
ICH’s recommended storage conditions
| Study | Storage condition | Minimum time period covered
by data at submission |
| Long Term* | 25°C ± 2°C / 60% RH ± 5% RH or
30°C ± 2°C / 65% RH ± 5% RH |
12 months |
| Intermediate** | 30°C ± 2°C/65% RH ± 5% RH | 6 months |
| Accelerated | 40°C ± 2°C/75% RH ± 5% RH | 6 months |
| Long Term | 5°C ± 3°C | 12 months |
| Long term | -20°C ± 5°C | 12 months |
| *It is up to the applicant to decide whether long term stability studies are performed at 25 ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/65% RH ± 5% RH. | ||
| **If 30°C ± 2°C/65% RH ± 5% RH is the long-term condition, there is no intermediate condition. | ||
Stability storage conditions at Q1 Scientific
-80°C
Ultra low – used mainly for storage of Biological samples eg. DNA, Serum & Plasma.
-20°C
For long term storage of Retains and Reference Standards and also Biologics.
2-8°C Refrigerated
Long term storage of Active Pharmaceutical Ingredients (API’s) or trial batches,
Injectables and some Biologics, Retain samples and Reference Standards
25°C/60% RH
Used for Bulk, Retain & Heritage Storage and Medical devices. (Storage of one’s DNA long term for possible future use). This condition is used for long term storage.
30°C/65% RH
Used for pharmaceutical and medical device product for either long term or intermediate storage.
30°C/75% RH
Used mainly for trial batches for product being distributed to hot/humid climate conditions.
40°C/75% RH
Product held at this accelerated condition is normally stored for 6 months only.
Contact us today
For more information on optimising your stability storage conditions, contact Q1 Scientific.
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