近日，USP在線論壇刊出文章建議將USP中受控室溫（20°–25°C）調(diào)整至15°C–25°C。如下：

 

Aligning Room Temperature Standards for Pharmaceuticals—A Sustainable Approach

 

統(tǒng)一藥品室溫標(biāo)準(zhǔn) —— 一種可持續(xù)的方法

 

ABSTRACT

This article proposes a revision to the United States Pharmacopeia (USP) definition of controlled room temperature (CRT) to align with the room temperature ranges recommended by the Japanese Pharmacopoeia (JP), European Pharmacopoeia (EP), and World Health Organization (WHO). The current discrepancy between USP’s CRT definition (20°–25°C) and the JP, EP, and WHO standards (15°–25°C) can lead to inconsistencies in drug storage practices and increased energy consumption. By aligning these standards, the pharmaceutical industry can reduce energy costs, minimize carbon emissions, and enhance global consistency in storage practices. This proposal emphasizes the importance of harmonization in promoting environmental sustainability, improving energy efficiency, and ensuring the safety and stability of pharmaceutical products. The article invites stakeholders to engage in discussions on the feasibility and benefits of this change, highlighting its potential to support global environmental goals and create a more sustainable future for the pharmaceutical industry.

 

摘要：本文提議修訂美國藥典（USP）中受控室溫（CRT）的定義，使其與日本藥局方（JP）、歐洲藥典（EP）和世界衛(wèi)生組織（WHO）推薦的室溫范圍保持一致。目前 USP 的 CRT 定義（20°–25°C）與 JP、EP 和 WHO 標(biāo)準(zhǔn)（15°–25°C）之間的差異，可能導(dǎo)致藥品儲(chǔ)存實(shí)踐不一致，并增加能源消耗。通過統(tǒng)一這些標(biāo)準(zhǔn)，制藥行業(yè)可以降低能源成本，減少碳排放，并提高全球儲(chǔ)存實(shí)踐的一致性。該提議強(qiáng)調(diào)了協(xié)調(diào)統(tǒng)一在促進(jìn)環(huán)境可持續(xù)性、提高能源效率以及確保藥品安全性和穩(wěn)定性方面的重要性。本文邀請利益相關(guān)者就這一變更的可行性和益處展開討論，突顯其在支持全球環(huán)境目標(biāo)以及為制藥行業(yè)創(chuàng)造更可持續(xù)未來方面的潛力。

 

OBJECTIVE

 

The objective of this proposal is to discuss a potential revision to the United States Pharmacopeia (USP) definition of controlled room temperature (CRT) to align with the room temperature ranges recommended by the Japanese Pharmacopoeia (JP), European Pharmacopoeia (EP), and World Health Organization (WHO). By aligning these standards, we seek to reduce energy consumption during winter months, minimize carbon emissions, and contribute to a more sustainable pharmaceutical industry.

 

目標(biāo)：本提議的目的是探討對美國藥典（USP）中受控室溫（CRT）定義進(jìn)行潛在修訂的可能性，以使其與日本藥局方（JP）、歐洲藥典（EP）和世界衛(wèi)生組織（WHO）推薦的室溫范圍保持一致。通過統(tǒng)一這些標(biāo)準(zhǔn)，我們旨在減少冬季的能源消耗，盡量減少碳排放，并為制藥行業(yè)實(shí)現(xiàn)更可持續(xù)的發(fā)展做出貢獻(xiàn)。

 

BACKGROUND

 

Pharmaceutical products are essential in maintaining public health, and consistent storage conditions are critical to ensuring the quality, safety, and efficacy of pharmaceutical products. Currently, there is a discrepancy between the USP's CRT definition (20°–25°C, with excursions permitted within the range of 15°–30°C) and the room temperature ranges defined by the JP, EP, and WHO (15°–25°C). This misalignment can lead to inconsistencies in drug storage practices and increased energy consumption.

 

背景：藥品對于維護(hù)公眾健康至關(guān)重要，而一致的儲(chǔ)存條件對于確保藥品的質(zhì)量、安全性和有效性至關(guān)重要。目前，USP 的 CRT 定義（20°–25°C，允許在 15°–30°C 范圍內(nèi)波動(dòng)）與 JP、EP 和 WHO 定義的室溫范圍（15°–25°C）存在差異。這種不一致可能會(huì)導(dǎo)致藥品儲(chǔ)存方面的差異，以及能源消耗的增加。

 

This Stimuli article discusses the potential benefits and implications of revising USP's CRT definition to align with the JP, EP, and WHO. By doing so, we hope to improve energy efficiency, reduce environmental impact, and facilitate global consistency in pharmaceutical storage practices.

 

本文討論了將 USP 的 CRT 定義修訂為與 JP、EP 和 WHO 一致的潛在益處和影響。通過這樣做，我們希望提高能源效率，減少對環(huán)境的影響，并促進(jìn)全球藥品儲(chǔ)存實(shí)踐的一致性。

 

History of USP's Definition of Controlled Room Temperature

 

The United States Pharmacopeia (USP) has a long history of defining storage conditions to ensure the stability and efficacy of pharmaceutical products. The controlled room temperature (CRT) definition first appeared in 1970 in USP 18: “Controlled Room Temperature is a temperature maintained thermostatically between 15° and 30°C (59° and 86°F)” (1). In 1990, USP 22–NF 17 Supplement 9, the CRT definition was revised to allow for temperature excursions and to update the temperature range to 20° to 25°C (68° to 77°F):

 

USP 受控室溫定義的歷史：美國藥典（USP）長期以來一直致力于定義儲(chǔ)存條件，以確保藥品的穩(wěn)定性和有效性。受控室溫（CRT）的定義最早于 1970 年出現(xiàn)在 USP 18 中：“受控室溫是指通過恒溫維持在 15°C 至 30°C（59°F 至 86°F）之間的溫度”(1)。1990 年，USP 22 - NF 17 補(bǔ)編 9 對 CRT 定義進(jìn)行了修訂，允許溫度波動(dòng)，并將溫度范圍更新為 20°C 至 25°C（68°F 至 77°F）：

 

"Controlled Room Temperature—A temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Articles may be labeled for storage at 'controlled room temperature' or at 'up to 25°C,' or other wording based on the same mean kinetic temperature. The mean kinetic temperature is a calculated value that may be used as an isothermal storage temperature that simulates the nonisothermal effects of storage temperature variations. (See also Stability under Pharmaceutical Dosage Forms ?1151?.) An article for which storage at controlled room temperature is directed may, alternatively, be stored in a cool place, unless otherwise specified in the individual monograph or on the label" (2).

 

“受控室溫 —— 通過恒溫維持的溫度，涵蓋通常和習(xí)慣的工作環(huán)境溫度 20°C 至 25°C（68°F 至 77°F）；計(jì)算得出的平均動(dòng)力學(xué)溫度不超過 25°C；并允許在藥房、醫(yī)院和倉庫中常見的 15°C 至 30°C（59°F 至 86°F）之間波動(dòng)。物品可以標(biāo)記為在‘受控室溫’或‘最高 25°C’或基于相同平均動(dòng)力學(xué)溫度的其他措辭下儲(chǔ)存。平均動(dòng)力學(xué)溫度是一個(gè)計(jì)算值，可作為模擬儲(chǔ)存溫度變化的非等溫效應(yīng)的等溫儲(chǔ)存溫度。（另見藥品劑型項(xiàng)下的穩(wěn)定性〈1151〉）。除非在各論或標(biāo)簽中另有規(guī)定，指示在受控室溫下儲(chǔ)存的物品，也可儲(chǔ)存在陰涼處”(2)。

 

This revision of the CRT definition coincided with updates to Pharmaceutical Dosage Forms?1151?, which included an increased emphasis on product stability and the introduction of mean kinetic temperature (MKT). The shift reflected a more nuanced understanding of how temperature fluctuations during storage impact the degradation of pharmaceutical products, leading to better alignment of storage conditions with stability requirements and ensuring the integrity and efficacy of products throughout their shelf life. The incorporation of MKT into the CRT definition underscores the importance of controlling storage environments, accounting for temperature excursions, and providing precise labeling guidance, particularly for products distributed internationally (3).

 

CRT 定義的此次修訂與藥品劑型〈1151〉的更新同步進(jìn)行，后者更加注重產(chǎn)品穩(wěn)定性，并引入了平均動(dòng)力學(xué)溫度（MKT）。這一轉(zhuǎn)變反映了對儲(chǔ)存過程中溫度波動(dòng)如何影響藥品降解有了更細(xì)致的理解，使儲(chǔ)存條件能更好地與穩(wěn)定性要求相匹配，確保產(chǎn)品在整個(gè)保質(zhì)期內(nèi)的完整性和有效性。將 MKT 納入 CRT 定義，突顯了控制儲(chǔ)存環(huán)境、考慮溫度波動(dòng)以及提供精確標(biāo)簽指導(dǎo)的重要性，特別是對于國際分銷的產(chǎn)品 (3)。

 

Current Definitions and Examples

 

當(dāng)前定義及示例

 

Japanese Pharmacopoeia (JP)

 

Cold: 1°–15°C

 

Standard temperature: 20°C

 

Room temperature: 15°–25°C (4)

 

Example: In Japan, certain vaccines and biologics are required to be stored at room temperature (15°–25°C), aligning with JP’s broader range. This allows for more flexibility during colder months (5).

 

日本藥局方（JP）

冷藏：1°C–15°C

標(biāo)準(zhǔn)溫度：20°C

室溫：15°C–25°C (4)

示例：在日本，某些疫苗和生物制品需在室溫（15°C–25°C）下儲(chǔ)存，符合 JP 更寬泛的溫度范圍。這在較冷的月份提供了更大的靈活性 (5)。

 

European Pharmacopoeia (EP)

 

Room temperature: 15°–25°C (6)

 

歐洲藥典（EP）

室溫：15°C–25°C (6)

 

World Health Organization (WHO)

 

Room temperature: 15°–25°C (7)

 

世界衛(wèi)生組織（WHO）

室溫：15°C–25°C (7)

 

International Council for Harmonisation (ICH)

 

No specific definition, but harmonization aligns with ICH principles (8)

 

國際人用藥品注冊技術(shù)協(xié)調(diào)會(huì)（ICH）

無具體定義，但協(xié)調(diào)統(tǒng)一符合 ICH 原則 (8)

 

United States Pharmacopeia (USP)

 

Controlled room temperature: 20°–25°C, with excursions permitted within the range of 15°–30°C (9)

 

美國藥典（USP）

受控室溫：20°C–25°C，允許在 15°C–30°C 范圍內(nèi)波動(dòng) (9)

 

Proposed Change

 

The proposal suggests revising the USP CRT definition for drug storage and transportation (i.e., distribution) from the current range of 20°–25°C.

 

提議的變更：該提議建議將 USP 中用于藥品儲(chǔ)存和運(yùn)輸（即分銷）的 CRT 定義，從目前的 20°C–25°C 范圍進(jìn)行修訂。

 

Rationale

 

理由

 

Energy costs and efficiency—Maintaining a controlled room temperature range of 20°C–25°C incurs significant energy costs, especially in regions with colder climates. For example, in the northern United States, where winter temperatures often drop below 0°C, maintaining the higher range requires extensive heating, which in turn increases energy consumption and costs.

 

能源成本和效率：維持 20°C–25°C 的受控室溫范圍會(huì)產(chǎn)生高昂的能源成本，尤其是在氣候較冷的地區(qū)。例如，在美國北部，冬季氣溫經(jīng)常降至 0°C 以下，維持較高的溫度范圍需要大量供暖，這反過來又增加了能源消耗和成本。

 

Environmental impact—Harmonizing room temperature standards can lead to reduced carbon emissions due to decreased energy usage. Aligning temperature recommendations contributes to global efforts to combat climate change, making the pharmaceutical industry more environmentally responsible. As we proceed through the 21st century, the importance of environmental sustainability is becoming more important. Reducing our carbon footprint and conserving energy are critical first steps towards a healthier planet (10).

 

環(huán)境影響：統(tǒng)一室溫標(biāo)準(zhǔn)可因能源使用減少而降低碳排放。統(tǒng)一溫度建議有助于全球應(yīng)對氣候變化的努力，使制藥行業(yè)在環(huán)境方面更具責(zé)任感。隨著我們步入 21 世紀(jì)，環(huán)境可持續(xù)性的重要性日益凸顯。減少碳足跡和節(jié)約能源是邁向更健康地球的關(guān)鍵第一步 (10)。

 

Global consistency—Harmonization simplifies international trade and distribution. Manufacturers can produce medicines with consistent storage requirements, facilitating smoother global supply chains and reducing logistical complexities. This consistency is particularly important in an era when global supply chains are increasingly interconnected and interdependent (11).

 

全球一致性：協(xié)調(diào)統(tǒng)一可簡化國際貿(mào)易和分銷。制造商可以生產(chǎn)具有一致儲(chǔ)存要求的藥品，促進(jìn)更順暢的全球供應(yīng)鏈，并降低物流復(fù)雜性。在全球供應(yīng)鏈日益相互關(guān)聯(lián)和相互依存的時(shí)代，這種一致性尤為重要 (11)。

 

Safety and stability—Scientific evidence supports that drug products remain stable within the proposed range of 15°–25°C. Studies have shown that lowering the temperature range does not significantly accelerate product degradation, ensuring the continued safety and efficacy of pharmaceuticals (12).

 

安全性和穩(wěn)定性：科學(xué)證據(jù)支持藥品在提議的 15°C–25°C 范圍內(nèi)保持穩(wěn)定。研究表明，降低溫度范圍不會(huì)顯著加速產(chǎn)品降解，確保了藥品的持續(xù)安全性和有效性 (12)。

 

Product wastage—Inconsistent temperature standards can lead to scenarios where pharmaceutical products are deemed unusable due to noncompliance with storage requirements. For instance, a product stored at 18°C may be acceptable in one region but not in another, leading to unnecessary disposal of otherwise safe and effective medications. This not only results in financial losses but also contributes to environmental waste (13).

 

產(chǎn)品浪費(fèi)：不一致的溫度標(biāo)準(zhǔn)可能導(dǎo)致藥品因不符合儲(chǔ)存要求而被視為不可用。例如，在一個(gè)地區(qū)儲(chǔ)存在 18°C 的產(chǎn)品可能在另一個(gè)地區(qū)不被接受，導(dǎo)致原本安全有效的藥物被不必要地丟棄。這不僅造成經(jīng)濟(jì)損失，還會(huì)造成環(huán)境浪費(fèi) (13)。

 

Discussion and Feedback

 

USP invites industry stakeholders to engage in a discussion about this proposed change. Your feedback is crucial in assessing the feasibility, benefits, and potential challenges of harmonizing the USP CRT definition. By collaborating, we can ensure that any revisions made to the standard are in the best interests of both the industry and the environment.

 

討論與反饋：USP 邀請行業(yè)利益相關(guān)者就這一提議的變更展開討論。您的反饋對于評估統(tǒng)一 USP CRT 定義的可行性、益處和潛在挑戰(zhàn)至關(guān)重要。通過合作，我們可以確保對標(biāo)準(zhǔn)所做的任何修訂都符合行業(yè)和環(huán)境的最佳利益。

 

CONCLUSION

 

Harmonizing USP’s CRT temperature range to 15°–25°C promotes energy efficiency, environmental responsibility, and product safety. This proposal serves as a starting point, and further discussions and collaboration among regulatory bodies, industry experts, and stakeholders are essential. Such a change will not only help enhance global consistency in drug storage practices but also support broader environmental goals. The benefits of reduced energy consumption and lower carbon emissions align with global efforts to combat climate change, making this harmonization a pivotal step toward a more sustainable future for the pharmaceutical industry. We look forward to your input and collaboration on this important initiative.

 

結(jié)論：將 USP 的 CRT 溫度范圍統(tǒng)一為 15°C–25°C，有助于提高能源效率、增強(qiáng)環(huán)境責(zé)任感并保障產(chǎn)品安全。本提議作為一個(gè)起點(diǎn)，監(jiān)管機(jī)構(gòu)、行業(yè)專家和利益相關(guān)者之間進(jìn)一步的討論和合作至關(guān)重要。這樣的變更不僅有助于提高全球藥品儲(chǔ)存實(shí)踐的一致性，還支持更廣泛的環(huán)境目標(biāo)。降低能源消耗和減少碳排放的益處與全球應(yīng)對氣候變化的努力相一致，使這種協(xié)調(diào)統(tǒng)一成為制藥行業(yè)邁向更可持續(xù)未來的關(guān)鍵一步。我們期待您對這一重要倡議的投入和合作。

 

DISCLAIMER

 

Stimuli articles do not necessarily reflect the policies of the United States Pharmacopeial Convention or the USP Council of Experts.

 

免責(zé)聲明：“刺激因素” 文章不一定反映美國藥典公約或 USP 專家委員會(huì)的政策。

 

[Note—The authors did not declare any perceived or actual conflicts of interest related to the subject matter of this Stimuli article. The views presented in this article do not necessarily reflect those of the organizations for which the authors work. No official support or endorsement by these organizations is intended or should be inferred.]

 

[注 - 作者未聲明與本文主題相關(guān)的任何已察覺或?qū)嶋H的利益沖突。本文所表達(dá)的觀點(diǎn)不一定代表作者所在組織的觀點(diǎn)。這些組織無意提供官方支持或背書，也不應(yīng)被推斷有此意圖。]

 

REFERENCES

 

參考文獻(xiàn)

 

United States Pharmacopeia. "Controlled room temperature" as defined under Preservation, Packaging, Storage, and Labeling in General Notices. In: USP 18; 1970.

 

United States Pharmacopeia. "Controlled room temperature" as defined under Preservation, Packaging, Storage, and Labeling in General Notices. In: USP 22–NF 17, Supplement 9; 1990.

 

United States Pharmacopeia. Pharmaceutical Dosage Forms ?1151?. In: USP 22–NF 17, Supplement 9; 1990.

 

Pharmaceuticals and Medical Devices Agency. General Notices. In: Japanese Pharmacopeia 18th Edition; 2021.

 

Ministry of Health, Labour and Welfare of Japan (MHLW). Storage and Handling of Pharmaceuticals; 2019.

 

European Directorate for the Quality of Medicines & HealthCare (EDQM). General Notices. In: European Pharmacopoeia 11th Edition; 2023.

 

World Health Organization (WHO). Good storage and distribution practices for medical products. Annex 7. WHO Technical Report Series, No. 1025; 2020. https://www.who.int/publications/m/item/trs-1025-annex-7.

 

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Q1A(R2): Stability Testing of New Drug Substances and Products. 2003. https://www.ich.org/page/quality-guidelines.

 

United States Pharmacopeia. Packaging and Storage Requirements ?659?. In: USP–NF; 2024.

 

Intergovernmental Panel on Climate Change (IPCC). Climate Change 2021: The Physical Science Basis; 2021. https://www.ipcc.ch/report/ar6/wg1/.

 

United Nations Conference on Trade and Development. Global Supply Chains: Trade and Economic Policies for Developing Countries. Policy Issues in International Trade and Commodities Study Series No. 55. United Nations; 2013.

 

World Health Organization (WHO). WHO guidelines on stability testing of active pharmaceutical ingredients and finished pharmaceutical products. Annex 10. WHO Technical Report Series, No. 1010; 2020. https://www.who.int/publications/m/item/trs1010-annex10.

 

World Health Organization (WHO). WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products; 2017. https://www.who.int/publications/i/item/9789241513425.