20140328 欧盟人用药GDP问答1.0（中英文）

囊萤映雪

20140328 欧盟人用药GDP问答1.0（中英文）

Ref. Ares(2014)968163 - 28/03/2014

EUROPEAN COMMISSION

HEALTH AND CONSUMERS DIRECTORATE-GENERAL

Health systems and products

Medicinal products – quality, safety and efficacy

Brussels,

GOOD DISTRIBUTION PRACTICE FOR MEDICINAL PRODUCTS FOR HUMAN USE

QUESTIONS AND ANSWERS

VERSION 1.0

人用药GDP问答 版本号1.0

Document history:
Date of submission of draft to the Pharmaceutical Committee[1]:	13 November 2013
Date of publication:	See above
Date of entry into force:	N/A
Supersedes:	N/A
Changes compared to superseded version:	N/A

文件历史
草案提交药品委员会日期	2013年11月13日
公开日期	见上
生效日期	不适用
前版本	不适用
与前版本相比变更	不适用

Important notice: The views expressed in this questions and answers document are not legally binding. Ultimately, only the European Court of Justice can give an authoritative interpretation of Union law. 重要提示：本问答文件中所表达的观点并无法规强制性。欧盟法律的最终解释权归属欧洲法院。

This documents sets out frequently-asked 'questions and answers' regarding the new guidelines on Good Distribution Practice of medicinal products for human applicable as of 8 September 2013[2], and their revision of November 2013[3].

本文件系针对2013年9月8日生效、2013年11月修正的人用药GDP新指南常见问题的“问答”。

1. QUESTION: IN CHAPTER 2 – PERSONNEL, 2.3.(1), WHAT IS THE DEFINITION OF “COMPETENT”?

Answer: Having the necessary experience and/or training to adequately perform the job.

问1：在第2章---人员中，2.3.（1），对“有能力”的定义是什么？

答：具备必须的经验和/或培训，足以胜任工作岗位。

2. QUESTION: CONCERNING CHAPTER 2 – PERSONNEL, 2.4.(1), IS IT POSSIBLE TO EMPLOY STAFF STARTING THEIR PROFESSIONAL CAREER?

Answer: Yes, if you properly training them before assigning them to their tasks.

问2：关于第2章---人员，2.4.（1），是否可能雇用无从业经验的人员？

答：可以，但你需要在让他们承担任务前对他们进行适当的培训。

3. QUESTION: IN CHAPTER 2 – PERSONNEL, 2.4.(5), WHAT IS MEANT BY “PERIODICALLY ASSESSED”?

Answer: Assessed at regular intervals. The timing of intervals is left flexible, without prejudice to national legislation.

问3：在第2章----人员，2.4.（5），“进行周期评估”是什么意思？

答：按固定的时间间隔进行评估。在不违反国家法规的前提下，评估的时间间隔可以灵活制订。

4. QUESTION: IN CHAPTER 2 – PERSONNEL, 2.5, DOES THE STATEMENT "APPROPRIATE PROCEDURES RELATING TO PERSONNEL HYGIENE, RELEVANT TO THE ACTIVITIES BEING CARRIED OUT, SHOULD BE ESTABLISHED AND OBSERVED" REFER TO THE HEALTH AND/OR CLEANLINESS OF THE STAFF?

Answer: It only refers to the cleanliness of the staff, so to avoid any alteration of the product.

问4：在第2章---人员，2.5，“应建立与人员卫生相关的适当程序，与要从事的活动相关，并进行监督”是指员工的健康和/或清洁卫生吗？

答：它仅指员工的清洁，以避免对产品的影响。

5. QUESTION: IN CHAPTER 3 – PREMISES AND EQUIPMENT, 3.2.(3), IS THE INTENT OF SEGREGATION TO AVOID “CROSS-CONTAMINATION” AS MENTIONED IN CHAPTER 5?

Answer: The intent of this provision is to avoid handling errors and accidental swaps of products. This is why electronic segregation is allowed, except for falsified, expired, recalled and rejected products which always have to be segregated physically.

问5：在第3章---设施和设备中，3.2.（3），如第5章所提及的，是否需要进行隔离以避免“交叉污染”？

答：本条款的目的是避免操作错误及对产品意外擦拭。这是为什么电子隔离也是允许的，只有假药、失效药、召回和不合格药品是必须采用物理隔离的。

6. QUESTION: CONCERNING CHAPTER 3 – PREMISES AND EQUIPMENT, 3.2.(7), IS THE LID OF A BOX / TOTE AN ADEQUATE PROTECTION AGAINST WEATHER CONDITIONS?

Answer: Any tool protecting products from prevailing weather conditions is acceptable.

问6：关于第3章---设备和设备，3.2.（7），盒子/手提箱的盖子用作应对天气环境的保护措施是否可接受？

答：所有用于保护产品应对天气环境的工具均是可以接受的。

7. QUESTION: CONCERNING CHAPTER 3 – PREMISES AND EQUIPMENT, 3.2.1, HOW MANY PROBES ARE NECESSARY TO MONITOR THE TEMPERATURE?

Answer: The number of probes and their placement depend on the risk analysis performed on the site and the placement should be in agreement with the mapping results.

问7：关于第3章---设备和设备，3.2.1，监控温度时，需要多少探头？

答： 探头数量及其放置位置取决于对场所进行的风险分析，放置位置应与温度分布结果相符。

8. QUESTION: CONCERNING CHAPTER 3 – PREMISES AND EQUIPMENT, 3.2.1.(2), WHAT IS MEANT BY INITIAL TEMPERATURE MAPPING?

Answer: An initial temperature mapping is an exercise in which temperature sensors are placed on the points identified as most critical through a risk analysis (e.g. at different heights, near a sunny window, next to the doors, etc.). Once placed, a measurement is taken over a period of time and with the results obtained, the temperature sensors will be places where greater fluctuation occurred. The mapping should be performed in different seasons where highest and lowest temperatures are reached.

问8：关于第3章---设备和设备，3.2.1.（2），初始温度分布测试是什么意思？

答：在初始温度分布测试是指将温度探头放置在通过风险分析被认为最关键的地方（例如，在不同高度，接近阳光照射的窗户，门边等）。放置后，在一段时间内对温度进行测量，根据所获得的结果，将温度探头放置在波动最大的地点。温度分布测试应在温度最高和最低的不同季节进行。

9. QUESTION: CONCERNING CHAPTER 3 – PREMISES AND EQUIPMENT, 3.3.(3), WHAT ARE APPROPRIATE SETTINGS FOR THE ALARM LEVELS?

Answer: Alarm settings should be chosen as to guarantee a timely alert of personnel when there are excursions from predefined storage conditions

问9：关于第3章---设施和设备，3.3.（3），警报水平怎么设定才适当？

答：警报设备的选择应保证在超出预定存贮条件时能及时通知相关人员。

10. QUESTION: CONCERNING CHAPTER 3 – PREMISES AND EQUIPMENT, 3.3.2.(1), IS IT REQUIRED TO HAVE ONLY EQUIPMENT WITH A CE CERTIFICATE OF CONFORMITY?

Answer: No. The CE marking is mandatory only for products dating from 1993 or later. It should be noted that the presence of a CE certificate of Conformity doesn’t exempt from equipment validation/qualification.

问10：第3章----设施和设备，3.3.2（1），是否只能使用符合CE要求的设备？

答：不是。CE标识从1993年起才是强制的要求。要注意具有CE符合性证书的设备并不能免于验证/确认。

11. QUESTION: CONCERNING CHAPTER 3 – PREMISES AND EQUIPMENT, 3.3.2.(1), IS IT REQUIRED TO RECORD ALL DEVIATIONS OR CAN THEY BE LIMITED TO SIGNIFICANT DEVIATIONS HAVING AN IMPACT ON PRODUCT SECURITY AND INTEGRITY?

Answer: All deviations from established procedures should be documented.

问11：第3章----设施和设备，3.3.2（1），是否要求记录所有偏差，还是仅记录对产品安全和完整性有影响的重大偏差？

答：所有偏离于既定程序的偏差都应记录。

12. QUESTION: CONCERNING CHAPTER 5 – OPERATIONS, 5.3.(3), ARE THERE ANY BEST PRACTICES FOR THE INVESTIGATION OF “UNUSUAL SALES PATTERNS”?

Answer: It is recommended to check for unusual repetition of orders, sudden increases of orders, and unusually low prices.

问12：第5章----运作，5.3.（3），对“异常销售模式”的调查是否有规范？

答：建议检查不正常的重复订单，订单忽然增加以及反常的低价。

13. QUESTION: CONCERNING CHAPTER 5 – OPERATIONS, 5.4.(3), HOW CAN WHOLESALERS PROVE THAT THE MEDICINES THEY RECEIVE ARE RELEASED FOR SALE?

Answer: The batches of medicinal products which have undergone the controls referred to in Art. 51 of Directive 2001/83/EC in a Member State are exempt from the controls if they are marketed in another Member State, accompanied by the control reports signed by the qualified person. In other words, the batch arriving from another member state needs to be accompanied by evidence that the manufacturer’s qualified person has certified the finished product batch for the target member state. The technical means by which this evidence is provided has been left to the discretion of the companies: a physical control report or an equivalent system of proof of release.

问13：第5章----运作，5.4.（3），批发商如何证明所收到的药品已经放行可用于销售？

答：药品如果已在另一成员国上市，随货有授权人签发的控制报告，根据指令2001/83/EC第51条控制的药品，在另一个成员国可以免于控制检查。换句话说，从另一成员国发来的药品需要随货有生产商的授权人对成品批次的放行用于到达成员国销售的批准。技术角度来说，公司有选择如何提供证据的自由：可以是纸质的控制报告，也可以是相当的放行证明系统。

14. QUESTION: CONCERNING CHAPTER 5 – OPERATIONS, 5.4.(3), CAN THE PROVISION REQUIRING WHOLESALERS TO PROVE THAT THE MEDICINES THEY RECEIVE ARE RELEASED FOR SALE BE MADE APPLICABLE AS OF 2017, WHEN MEDICINAL PRODUCTS WILL CARRY SAFETY FEATURES THAT CAN BE CHECKED THROUGH A DATABASE?

Answer: No, these provisions are already into operation as the new GDP guideline simply repeats what mentioned in Directive 2001/83/EC.

问14：第5章----运作，5.4.（3），要求批发商证明所收到的药品已经过放行用于销售的条款是否可以在2017年，当药品带有安全信息并可以通过数据库查询时才实施？

答：不可以。这些条款已经生效，而新的GDP指南只是重复了指令2001/83/EC中所提到的内容。

15. QUESTION: IN CHAPTER 5 – OPERATIONS, 5.5.(1), WHAT IS THE DEFINITION OF “SEPARATELY”?

Answer: This provision refers to physical separation only in case of presence of other products likely to alter the medicinal product. Segregation is also necessary for falsified, expired, recalled and rejected medicines. In all other cases, electronic segregation is possible.

问15：第5章----运作，5.5.（1），“分别”是什么定义？

答：本条款所指物理隔离仅是在其它产品可能对药品有影响时需要。对于假药、失效药、召回药和不合格药品也需要进行隔离。在其它情况下，可以采用电子隔离。

16. QUESTION: CONCERNING CHAPTER 5 – OPERATIONS, 5.5.(8), IN WHAT WAY SHOULD INVESTIGATION AND DOCUMENTATION BE DONE?

Answer: Reasons for stock irregularities should be investigated and documented.

问16：第5章----运作，5.5.（8），调查和记录要如何进行？

答：对不正常的库存应调查其原因并记录。

17. QUESTION: CONCERNING CHAPTER 6 – COMPLAINTS, RETURNS, SUSPECTED FALSIFIED MEDICINAL PRODUCTS AND MEDICINAL PRODUCT RECALLS, 6.3.(2)(I), HOW CAN WHOLESALERS VERIFY THAT A PACK HAS NOT BEEN OPENED IF IT DOES NOT CARRY AN ANTI-TAMPER DEVICE?

Answer: The anti-tampering device will become compulsory in the coming years. Meanwhile, check to the best of your capacities whether the pack has signs of tampering.

问17：在第6章---客诉、退货、疑似假药和召回药品，6.3.（2）（I），如果包装没有防伪装置，批发商如何确认一个包装是否被打开过？

答：防伪装置在未来几年会成为强制要求。同时，尽你所能检查包装是否有被伪装的痕迹。

18. QUESTION: CONCERNING CHAPTER 6 – COMPLAINTS, RETURNS, SUSPECTED FALSIFIED MEDICINAL PRODUCTS AND MEDICINAL PRODUCT RECALLS, 6.3.(2)(III), HOW SHOULD THE CUSTOMER DEMONSTRATE THAT THE MEDICINAL PRODUCTS HAVE BEEN TRANSPORTED, STORED AND HANDLED IN COMPLIANCE WITH SPECIFIC STORAGE REQUIREMENTS?

Answer: The customer needs to provide papers showing that the medicinal products have been transported, stored and handled in compliance with their specific storage requirements.

问18：在第6章---客诉、退货、疑似假药和召回药品，6.3.（2）（III），客户如何证明药品的运输、存贮和处理符合指定的存贮要求？

答：客户需要提供书面证据，证明药品的运输、存贮和处理符合其指定的存贮要求。

19. QUESTION: CONCERNING CHAPTER 6 – COMPLAINTS, RETURNS, SUSPECTED FALSIFIED MEDICINAL PRODUCTS AND MEDICINAL PRODUCT RECALLS, 6.3.(3), WHAT SHOULD THE DOCUMENTED EVIDENCE CONTAIN TO BE REGARDED AS SUFFICIENT?

Answer: The evidence should cover:

(i) delivery to customer;

(ii) examination of the product;

(iii) opening of the transport packaging;

(iv) return of the product to the packaging;

(v) collection and return to the distributor;

(vi) return to the distribution site refrigerator.

问19：在第6章---客诉、退货、疑似假药和召回药品，6.3.（3），书面证据包括哪些内容才能认为是充分的？

答：证据应包括：

（1）给客户发送的信息

（2）对产品的检查

（3）运输包装打开信息

（4）将产品放回包装的信息

（5）从销售商中收货和退回的信息

（6）退回销售商场所的冷冻箱

20. QUESTION: IN CHAPTER 6 – COMPLAINTS, RETURNS, SUSPECTED FALSIFIED MEDICINAL PRODUCTS AND MEDICINAL PRODUCT RECALLS, 6.3.(3)(IV), DOES THE TERM "PACKAGING" REFER TO THE TRANSPORT BOX?

Answer: Yes

问20：在第6章---客诉、退货、疑似假药和召回药品，6.3.（3）（IV），术语“包装”是否指运输箱？

答：是的。

21. QUESTION: IN CHAPTER 6 – COMPLAINTS, RETURNS, SUSPECTED FALSIFIED MEDICINAL PRODUCTS AND MEDICINAL PRODUCT RECALLS, 6.5.(6), WHAT DOES IT MEAN TO RECORD THE PROGRESS OF THE RECALL?

Answer: You need to record the status of the recall and whether it was successful or not.

问21：在第6章---客诉、退货、疑似假药和召回药品，6.5.（6），记录召回过程是什么意思？

答：你要记录召回状态，及召回是否成功。

22. QUESTION: CONCERNING CHAPTER 9 – TRANSPORTATION, 9.2.(1), CAN WE DEVIATE FROM STORAGE CONDITIONS IF THE MANUFACTURER AGREES TO THE TRANSPORTATION OF THE PRODUCT WITHIN A CERTAIN TEMPERATURE RANGE (2°-25°C) FOR A LIMITED TIME FRAME OF 6 HOURS?

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

问22：关于第9章---运输中，9.2.（1），如果生产商允许产品在一定6小时内，在一定温度范围内（2°-25°C）运输，我们的存贮条件是否可以允许偏差？

答：不允许。在整个运输链中各运输环节均需要遵守生产商所描述的，或外包装上描述的存贮温度限度。

23. QUESTION: CONCERNING CHAPTER 9 – TRANSPORTATION, 9.2.(9), ARE TRANSPORTATION COMPANIES REQUIRED TO HOLD A WHOLESALE DISTRIBUTION AUTHORISATION AND COMPLY WITH GDP?

Answer: Transport companies do not need to hold a wholesale distribution authorisation to transport medicinal products. However, they should follow the parts of the GDP guideline relevant to their activities, amongst others Chapter 9.

问23：关于第9章----运输，9.2.（9），运输公司是否需要持有批发分销授权证书，并符合GDP要求？

答：运输公司运输药品时不需要持有批发分销授权证书。但是，他们要遵守GDP指南第9章及其它章节中关于其活动的要求。

24. QUESTION: IN CHAPTER 9 – TRANSPORTATION, 9.4.(2), DOES THE DEFINITION OF HIGHLY ACTIVE MATERIAL COMPRISE CYTOSTATICS?

Answer: The guidelines do not include a list of highly active materials, or a definition of highly active material. Without prejudice to specific provisions included in national legislation, the wording leaves a margin of manoeuvre to the manufacturer/ distributor.

问24：在第9章---运输中，9.4.（2），高活性物料的定义是否包括细胞抑制剂？

答：指南中没有高活性物料清单，或对高活性物料的定义。在不违反国家法规特定条款的前提下，该用词给生产商/销售商留有自由诠释的余地。

25. QUESTION: IN CHAPTER 9 – TRANSPORTATION 9.4.(7), WHAT IS THE DEFINITION OF “CHILLED”?

Answer: "Chilled" refers to refrigerated storage conditions.

问25：在第9章---运输中，9.4.（7），“冷却”的定义是什么？

答：“冷却”指冷冻存贮条件。

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[1]  http://ec.europa.eu/health/documents/pharmaceutical-committee/index_en.htm  

[2] Guidelines of 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use, OJ C 68, 8.3.2013, p. 1.

[3] Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use, OJ C 343, 23.11.2013, p. 1.

oО星辰﹏

辛苦了，谢谢分享。