你好,欢迎光临!温湿度记录仪,温湿度变送器,温湿度控制器,温湿度监控系统-深圳市英斯特科技有限公司官网  contact-icon01.png183-207-99158 com_phone.png 0755-36527211☆淘宝商城

深圳市英斯特技有限公司

示例图片三
网站首页 > 新闻资讯 > 业界资讯

对各国对药品储运过程中温度超支的情况如下

2016-06-08 23:01:35 深圳市英斯特技有限公司 阅读

欧盟GDP

文献1

“The application of MeanKinetic Temperature (MKT) to temperature monitoring of wholesale products isonly appropriate where an acceptable MKT value is provided by the MA holder fora specific product, and the recording of temperature can be confirmed to beconsistent and complete from the moment of leaving the manufacturer’s premises.In practice the application of MKT fails where a complete chain of temperaturerecording cannot be allocated to a specific consignment of a product. Attemptsto apply MKT have been proposed by wholesalers as an alternative to havingadequate temperature control within their warehouses as well as attempting todowngrade the impact of temperature excursions. The use of MKT in the wholesaleenvironment without robust supporting information and methodology is thereforediscouraged”.

只要在上市答应证持有人对特定商品供给了可接受的均匀动力学温度值(MKT),且自商品脱离生产商厂房后温度记载与实际相符且完好,才能够运用MKT对批发商品进行温度监控。事实上,假如一个商品没有相应的完好温度记载,是不能运用MKT的。批发商建议测验运用MKT,把MKT作为对库房温度进出充分操控的一种挑选,一起也作为测验下降温度剧增所形成的影响的一个路径。假如没有有力的支撑信息和办法,批发商是不答应运用MKT的。

——MHRA博客:冷藏药品的杰出分销标准(GDP)

Refrigeratedmedicinal products, part 2: Transportation, packing, temperature management,the use of third party couriers and returns – some things to consider

有关冷藏药品的第二有些:运送、包装、温度操控、第三方运送的运用以及退货过程中的注意事项


文献2

Question:concerning chapter 9 – transportation, 9.2.(1), can we deviate from storageconditions if the manufacturer agrees to the transportation of the productwithin a certain temperature range (2°-25°c) for a limited time frame of 6hours?

Answer: No.Storage temperature limits as described by the manufacturer or on the outerpackaging need to be respected for each stage of transport during the wholetransport chain.

疑问:对于第9章---运送中,9.2.(1),假如生产商答应商品在必定6小时内,在必定温度规模内(2°-25°C)运送,咱们的存贮条件是不是能够答应误差?

答:不答应。在全部运送链中各运送环节均需求恪守生产商所描绘的,或外包装上描绘的存贮温度极限

——GOOD DISTRIBUTION PRACTICE FOR MEDICINALPRODUCTS FOR HUMAN USE

QUESTIONS ANDANSWERS

VERSION 1.0

人用药GDP问答版本号1.0


文献3

The EU Good Distribution Practice (GDP) Guidelines (2013/C 343/01) revisedin 2013 reflect the requirements and expectations of the authorities during thetransport and distribution of medicinal products in a very detailed way.Nevertheless, there are still questions and insecurities.

2013年修订后的欧盟GDP指南(2013/C343/01)以非常具体的方法反映了官方对于药品运送和出售的希望和请求。不过,仍是有一些疑问不太明白。

Especiallyquestions on temperature control during transport are recurring. This questionis examined in detail in a corresponding questions and answers paper of the German ZLG (Zentralstelleder L?nder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten/Central Authority of the German Federal L?nder for Health Protection RegardingMedicinal Products and Medical Devices) (in German language).

特别是对于运送途中的温度疑问再次被提出。这个疑问在“德国ZLG问答”中有了一些具体的回答,不过是德文的。(据德国搭档介绍,ZLG是德国药品和医疗器械担任批阅类的组织)

Here, it isstated that a temperature control is not required for each transport:

其间阐明晰并不是每一次运送中都请求对温度进行操控

'If noconstant monitoring of temperature is carried out during the transport ofmedicinal products a risk assessmentmust be made of thetransportation routes. This includes especially the travel duration includingspecial aspects of the route, the time of year and day, including the weatherforecast, the vehicles used and their equipment. The results of this riskassessment have to be part of the transportation planning.'

“假如在药品运送中没有施行持续的温度监控,则有必要对运送道路进行危险评估。评估特别要包含运送时刻,包含道路的特别疑问,时节和天数,包含天气预报,所用的货车及其装备。该危险评估的成果有必要成为运送方案的一有些。”

But at the sametime this means that monitoring has to be done if no risk assessment wascarried out or if the risk assessment led to the result that a temperaturecontrol is necessary.

但一起,这也表示假如没有进行危险评估,那就有必要进行监控,或者假如危险评估结论是需求对温度进行操控,那也有必要进行监控。

According to theZLG document a lot of things have to be considered when carrying out the riskassessment:

根据ZLG文件,在进行危险评估时有必要要思考很多疑问:

·        The mean kinetic temperature (MKT) cannot be used. The reason is that it does not takeinto consideration effects 'that may lead to irreversible quality defectseven when certain temperature limits that are established during stabilitystudies in connection with the marketing authorisation are exceeded only for ashort time. And it does not take into consideration the possible formation offissures in the glass of ampoules and injection bottles at temperatures aroundthe freezing point. Furthermore, calculation of the MKT requires that the temperatureprofiles of all transports are known that have been carried out previously. Butusually this data is not available ....' 

·        不能运用均匀动力学温度(MKT。理由是它没有思考到影响“也许会引起不可逆的质量缺点,即便在安稳性研究时期已树立了与上市答应有关联的特定温度极限仅仅超出了很短的时刻。它没有思考在冷冻点上下的温度也许会使得安瓿和注射用瓶的玻璃发生龟裂。别的,MKT核算需求知道之前已施行的一切运送过程中的温度概略。但一般这些数据是无法取得的……”

·        In order to assess deviations 'appropriateprocedures' must be established. 

·        为了评估误差,有必要树立“恰当的程序

·        Storage conditions must generally be respected alsoduring transportation. 'Only in cases that according to the packagingor the confirmed written information given by the manufacturer, thepharmaceutical entrepreneur or the marketing authorisation holder. a transportwithin the aforementioned temperature range will not reduce the quality'this temperature range can be handled more generously. It has been demonstratedfor example 'in connection with the marketing authorisation of medicinalproducts on the labelling of which only storage between +2 and +8 °C isindicated that they remain sufficiently stable even if the temperature rises upto +25 °C for a short time.'

在运送过程中有必要恪守存贮条件。“只要当根据生产商、药品公司或上市答应持有人供给的包装或确认的书面信息,在上述温度规模内的运送将不会下降质量”,这么的温度规模才也许更灵敏。例如,已证实“与药品上市答应有关的标签阐明只能存贮在+2到+8 °C,即便温度在短时刻内高至 +25°C其质量仍坚持满足安稳。”

——GMPNews

22/04/2015

GDP:Is Temperature Control required for each Transport?

GDP:是不是每次运送均需求对温度进行操控?



美国USP

10.30.40. ControlledCold Temperature

受控的冷藏温度

 “Controlled cold temperature” is defined astemperature maintained thermostatically between 2° and 8° (36° and 46° F), thatallows for excursions in temperature between 0° and 15° (32° and 59° F) thatmay be experienced during storage, shipping, and distribution such that theallowable calculated mean kinetic temperature(MKT) is not more than 8°(46° F). Transient spikes up to 25° (77° F) may bepermitted if the manufacturer so instructs and provided that such spikes do notexceed 24 hours unless support

温度坚持在2°和8°(36°和46℉)之间。在贮存、运送、分销过程中,答应温度在0°至15°(32°和59℉)之间动摇但均匀动力学温度(MKT)不超越8°(46℉)顷刻最高温度答应到达25°(77℉),超越温度的最长时刻不得过24小时,除非安稳性数据或是其他厂商的阐明支撑。


10.30.60.Controlled Room Temperature

受控的室温

 “Controlled room temperature” indicates atemperature maintained thermostatically that encompasses the usual and customaryworking environment of 20° to 25° (68° to 77°F); that results in a mean kinetictemperature(MKT) calculated to be not more than 25°; and that allows forexcursions between 15° and 30° (59° and 86°F) that are experienced inpharmacies, hospitals, and warehouses. Provided the mean kinetic temperatureremains in the allowed range, transient spikes up to 40° are permitted as longas they do not exceed 24 hours.

Spikes above 40°may be permitted if the manufacturer so instructs. Articles may be labeled for storageat “controlled room temperature” or at “up to 25°”, or other wording based onthe same mean kinetic temperature. The mean kinetic temperature is a calculatedvalue that may be used as an isothermal storage temperature that simulates thenonisothermal effects of storage temperature variations. (See alsoPharmaceutical Stability ?1150?.)

受控的室温指一般保持在20~25(68℉~77℉)稳定温度,其MKT值不该超越25,并且根据经历,答应在药房、医院和库房偏移至15~30(59℉~86℉)。保持MKT在规则的规模,即便时间短的到达40并且不超越24小时也是答应的。假如超越40℃则需求制造商别的阐明。阐明书中能够注明贮存在受控的室温或最高25℃或其他基于相同MKT值的温度。均匀动力学温度(MKT)指用一个等温贮存温度核算值来模仿各种不一样的贮存温度的影响。


An article forwhich storage at controlled room temperature is directed may, alternatively, bestored and distributed in a cool place, unless otherwise specified in theindividual monograph or on the label.

假如阐明书规则了在受控的室温下贮存,那么相同也能够在阴凉条件下(cool8~15)贮存和运送,除非在USP各论或商品标签上有独自的特别规则。


10.30.30. Cool

阴凉

Any temperature between8° and 15° (46° and 59°F) is“cool.” An article for which storage in a coolplace is directed may, alternatively, be stored and distributed in a refrigerator,unless otherwise specified by the individual monograph.

阴凉温度是指8~15之间(46℉~59℉)。假如阐明书中规则了在阴凉条件下贮存,那么相同也能够在冷藏条件下贮存和运送,除非在USP各论中有独自的特别规则。

——USP  GENERAL NOTICES AND REQUIREMENTS凡例


综上,对各国对药品储运过程中温度超支的情绪如下:

国家

温度误差

我国

1、能够经过长期、加快安稳性数据评估温度误差

2、不答应以加快实验数据评估成果为根据直接放宽储运条件

3、运送验证(思考最差条件)

欧盟

1、运用MKT评估温度误差需求有满足信息支撑

2、并不是每一次运送中都请求对温度进行监控,但要进行危险评估

3、假如没有危险评估,那就有必要进行温度监控

不能运用MKT作为下降危险的办法

美国

1、答应核算MKT来评估储运条件是不是契合(药典特别规则的种类在外)

2、答应低温(指低于规则贮存温度)储运。

本文由温湿度记录仪,温湿度变送器,温湿度控制器,英斯行科技原创提供,转载请注明出处:http://www.inste.com.cn

Powered by Inste 5.3.19 ©2008-2018 www.inste.com.cn