Specificity Seems to be all the Rage this Season
I came across an article about, "stability data vs USP 36" on your website. I am having a difficult time trying to find out if USP has changed the definition of controlled room temperature to 2°C to 8° C. Do you know if this is now an acceptable range for any drugs that refers to USP controlled room temperature on their package insert?
Thanks for your help!
Thanks for reaching out! I don't think USP will change their definition of "Controlled Room Temperature" any time soon. If they did, all the manufacturers relying on the current definition would be out of luck. For now, and the foreseeable future, it will stay 20°C to 25°C with allowable excursions to 15°C and 30°C (For convenience, I am leaving out all the other parts of the definition, such as MKT, transient spikes to 40°C, etc.).
It is important to note that in the General Notices and Requirements for USP 36 they say that items classified for "controlled room temperature" storage may be stored in a "cool place" (unless otherwise specified on the label or monograph). When the USP says "cool place" they aren't talking about the hip new cocktail bar that opened down the street. They mean 8°C to 15°C. So, technically your allowable storage range for CRT may be as wide as 8°C to 25°C.
I predict that drug manufacturers themselves will abandon the term "Controlled Room Temperature" and state explicitly what their product can tolerate for storage. This is in alignment with USP 36 <1079>, which recommends specificity in product labelling of temperature ranges:
"Product labels should clearly define the storage temperature range, and broader distribution or in-use temperature ranges where allowable. Products labeled "Keep in a cold place" or "Do not freeze" are subject to interpretation and are discouraged if used without accompanying temperature ranges."
-USP 36 <1079>
The shift toward greater specificity when documenting product storage conditions is already happening. Note also that USP 36 <1079> makes no mention of controlled room temperature or room temperature. Instead, they talk about ranges and limits in quantified values: E.g.: "Typically, a refrigeration unit specification would be set to 5 with an allowable range of ±3° to store products labeled 2 - 8°C…"
I see by your title that you are a pharmacist. Given your training and experience you likely understand that if something says "Controlled Room Temperature" it means 20-25°C. I wouldn't put anything in a refrigerator that did not specifically say "2-8°C" or "store refrigerated".
I am with you on curiosity about the definition and use of CTR. I anticipate that over the next few years manufacturers will be updating their labels away from any terms that can be misinterpreted or loosely applied.
Best Regards,Paul Daniel
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Paul Daniel is the Senior Regulatory Compliance Expert at Vaisala. He has worked in the GMP-regulated industries for over 20 years helping manufacturers apply good manufacturing practices in a wide range of qualification projects. His specialties include mapping, monitoring, and computerized systems.
At Vaisala, Paul oversees and guides the validation program for the Vaisala viewLinc environmental monitoring system. He serves as a customer advocate to ensure the viewLinc environmental monitoring system matches the demanding requirements of life science and regulated applications.
Paul also shares his GMP experience through regular blog contributions, webinars, and seminars around the world. Paul’s expertise in the demanding GxP world is applicable to any industry where measurement is critical to product quality. Paul is a graduate of University of California, Berkeley, with a bachelor's degree in biology.