A stimuli article authored by Desmond Hunt, Ph.D., Senior Scientific Liaison at USP, and several members of the pharmaceutical industry has been initiated with the objective to solicit public comment and stimulate discussion regarding a potential revision—as yet unproposed in PF—of USP’s definition for Controlled Room Temperature. The proposal advances the view to expand the current definition of Controlled Room Temperature (CRT) from +20°C to +25°C to +2°C to +30°C.
The brief provides an overview of justification based on changes in drug product stability studies and practices with a focus on temperature control during storage and distribution. The article states that the current range is very narrow and obsolete, as it does not take into account current expanded drug product stability data developed for distribution purposes in recent years. They conclude such data support redefining controlled room temperature (CRT) by broadening the permitted range for shipping when appropriate for specific products. The CRT of today makes it difficult to ship products at their labeled storage range, as is required.
Tight storage ranges can result in perceived shipping excursions and rejected lots for products that would certainly meet USP product specifications. Thus, the lack of an industry-accepted CRT label range creates difficulties in distribution controls. In addition, the current technology (e.g., temperature monitoring, packaging) in place for temperature-controlled products has been developed specifically for products distributed at +2°C to +8°C, and when utilized for CRT distribution, tends to be costly and extremely inefficient.
The article sites the following positive benefits of an expanded, standardized range for CRT in USP:
- It would be consistent with other countries’ Ministries of Health;
- Facilitate in the distribution of drug products;
- Remove uncertainty;
- Promote long-term value to industry by building a strong foundation of stability data;
- Promote the efficient distribution of products among global partners in the ever-expanding CRT and cold chain environment.
You can download the Stimuli Article below:
The USP welcomes comments from qualified members of industry.
Correspondence should be addressed to: Desmond G. Hunt, Ph.D., Senior Scientific Liaison, USP, 12601 Twinbrook Parkway, Rockville, MD 20852-1790; 301.816.8341; e-mail firstname.lastname@example.org.