the
compliance
group
Stan O’Neill
CPAPE 2011 年会
欧盟药品药品流通法规
EU Regulations on Drug Distributions
Guidelines on Good Distribution Practice of Medicinal Products for Human Use[Article 10 EU Dir 92/25/EEC]人用药品流通质量管理指南 [欧盟第92/25/EEC号法令第10款]
Personnel 人员
Documentation 文件
Premises and Equipment 房屋与设备
Deliveries to Customers 向客户交付
Returns 退货
Self Inspections 自检
Ensure products are authorised
保证产品经过批准
Storage conditions are observed (all times)
关注产品储存条件(任何时候)
Prevent contamination from other products
预防来自其它产品的污染
Ensure adequate turnover of products
保证足够的产品流转量
Deliver right products 交付产品正确无误
Quality System Operated by Wholesalers should 批发商的质量系统应
Right Address
发货地址正确
Satisfactory Period
发货斯让用户满意
Provide tracing system for faulty products
具备追踪系统，追踪有问题的产品
Effective Recall Procedure
有效的召回程序
Quality System Operated by Wholesalers should 批发商的质量系统
Appoint Management Representative - “Responsible Person”- each distribution centre
每个分销中心须指定-“负责人”-即管理代表
Appropriately qualified 适当的资质
Implement and maintain Quality System
来实施与保持质量系统
Key Personnel 关键人员
Appropriate ability and experience to guarantee products are properly handled
有适当的能力与经验来保证产品正确处理
Personnel 人员
Training 培训
Provide training for various GDP operations
提供不同GDP操作的培训
Training programmes
培训计划
Maintain training records
保存培训记录
Personnel 人员
Procedures 程序
Written procedures should describe the different operations which may affect
应当有书面规程来描述不同的操作，它们可能影响：
the quality of the products 产品质量
the distribution activity 分销活动
Procedures for 有以下规程：
- Receipt and checking of deliveries 发送产品的接收/检查
- Storage 储存
Cleaning and maintenance of premises
贮存厂房的清洁与维护
Documentation 文件
Procedures Cont’d 程序(续)
Recording of storage conditions 记录储存条件
Security on site or in transit 现场或运送安全
Withdrawal from saleable stock 从销售仓库撤回
Records of - orders 记录 -定单
- returned products - 退货
Recall plans 召回计划
Procedures for various operations should be approved, signed and dated by the Responsible Person
各种规程均应经过负责人的批准，签字与签发日期
Documentation 文件
Records 记录
Made when each operation is taking place
每次操作时均应记录
Activities and events are traceable 活动/事件均可追踪
Readily available 方便查阅
Retained for 5 years at least 至少保留5年
Each purchase and sale 每次采购与销售有：
Date 日期
product/quantity 产品/数量
name and address of supplier/consignee
发货企业/收货人的名称与地址
Documentation 文件
Records Cont’d 记录(续)
Transactions between 以下交易的记录：
(i) Manufacturers and Wholesalers
制造企业与批发企业
(ii) Between Wholesalers 批发企业之间
ensure traceability of origin/destination products . Batch numbers to identify suppliers and those supplied with medicinal products
能保证产品起点/终点的追踪性，如用批号来识别供应商及其发的药品
Documentation 文件
Suitable and adequate to ensure proper conservation/ distribution 适用并足以保证贮存/分销正确无误
Monitoring devices should be calibrated 监控装置应当进行校准
Receiving 接收
Receiving bays protect deliveries 有保护收货的区域
Receiving area separate from storage areas
收货区域与储存区域分开
Deliveries examined on receipt 在收货时检查产品
Damage 有无损坏
corresponds to the order 与定单是否相符
Premises and Equipment
库房设施与设备
Storage 储存
Medicinal products separate from other goods
药品与其它产品分开
Conditions specified - protect from light, moisture, below 25℃ 规定条件-避光,防潮,低于25℃
Temperature monitoring documented
温度监测有记录
Records reviewed regularly 定期审核记录
Temperature Mapping. Storage areas/cold rooms 温度分布、储存区/冷库
Premises and Equipment
库房设施与设备
Ensure all locations within specific temperature range
保证所有区域都在规定的温度范围内
> 25oC
2 - 8oC
Premises and Equipment
库房设施与设备
Storage Facility 储存设施
Clean 清洁
Free from litter, dust, pests 无废弃物、灰尘、虫害
Free from spillage or breakage 没有溢出或损坏
Microcontamination 微生物污染
Cross contamination 交叉污染
Stock Rotation 库存流转
“First in First out” Regular checks
“先进先出”定期检查
Premises and Equipment
库房设施与设备
Out of Date or Damaged Stock 将过期或损坏库存
Quarantine 隔离/待检
Destroy 销毁
Premises and Equipment
库房设施与设备
Authorised Wholesalers 批准的批发商
Persons authorised to supply Medicinal Products
经批准可从事药品流通的人员
IMB will look randomly at customer list
爱尔兰药品管理局将在客户清单中随机抽查
Supply Document 提供的文件应有：
Date 日期
Name and Pharmaceutical Form 名称与药品剂型
Quantity supplied 供应数量
Deliveries to Customers
向客户发货
Supplier and addressee 供应商以及地址
Name and address 名称与地址
Product Shelf Life 产品有效期
Product dispatched must have a minimum defined shelf life remaining
所发送的产品必须具有所规定最短有效期
Deliveries to Customers
向客户发货
Transportation 运输
Ensure that 保证：
Identification is not lost 不丢失标识
Cross Contamination is avoided 避免交叉污染
Products are secure 产品安全
Breakage & theft are avoided 避免损坏与偷窃
Protected from unacceptable environmental conditions 防止环境条件不符合要求
Temperature is controlled during transport
在运输中温度受控
Deliveries to Customers
向客户发货
Cold Chain 冷链
Products requiring refrigeration must be delivered in
需要冷冻产品必须在下列条件下发运
Refrigerated transport 冷冻运输
Insulated boxes 绝热箱
Validate worst case situation during transport
验证在运输中最坏情况状态
Ensure product does not come in contact with ice packs
保证产品不接触冰袋
Responsible Person - ensure adequate delivery conditions maintained 负责人-保证保持足够的交付条件
Deliveries to Customers
向客户发货
Controlled Drugs 受控药物
Maintain Security Chain 保持发货各环节的安全
Separate control drugs in deliveries to facilitate transfer
受控药品要采用单独发送方式，方便移交
Deliver direct to pharmacist at the hospital or retail outlet
直接交到医院或零售店的药剂师
Deliveries to Customers
向客户发货
Non Defective Medicinal Products 无缺陷药品
Segregation from Saleable Stock until checked
与销售库存相隔离，直到经过检查
Products in good condition - original unwrapped containers
产品保持良好状态 -- 容器为原始包装未经开封
Products stored under proper conditions
产品在正确条件下储存
Remaining shelf life acceptable
仍有可接受的有效期
Returns 退货
Products examined and assessed by authorised, trained personnel
产品由经过批准及培训人员的检测与评估
Special storage conditions - time elapsed since issue
特别储存条件-自从发货起的持续时间
Maintain records of returned goods
保存退货记录
Return to stock operating FIFO System
退回仓库，按先进先出要求管理
Returns 退货
Product Disposal 产品处置
Returned, Rejected or Recalled Products
退回，拒绝或召回产品
Decision documented & recorded by Responsible Person
决定文件与负责人的记录
Disposal in a timely manner
以及时的方式处置
Returns 退货
Conduct and Record Self Inspections to monitor the implementation of and compliance with GDP Guidelines
对执行流通管理规范情况进行自检并做好记录：
Self Inspection Procedure 自检程序
Inspection Reports 检查报告
Follow up Actions 跟踪措施
Inspection Log 检查日志
Self Inspection 自检
Quality Management 质量管理
No Quality System available 没有质量系统
No System for Control of Documentation - Issue/Retrieval 无系统控制文件的发放/与收回
Master copies SOPS not approved by R. Person
基准SOP（原版）没有经过负责人批准
No Policy re.没有以下相关的方针：
Minimum acceptable product dating
最短可接受产品有效期
Return of refrigerated products 冷冻产品退货
GDP Deficiencies – General
执行流通规范常中的见缺陷
Personnel 人员
Company training programme not available
公司没有培训计划
No training SOP for GDP operations
没有培训流通管理规范的SOP
Personnel training not documented
人员培训没有记录
GDP Deficiencies – General
执行流通规范常中的见缺陷
Documentation 文件
Relevant SOPs not available in areas of operation
在操作区域没有相关的SOP
SOPs not available for 没有下列SOP：
Receipt and checking of deliveries
对到货的接收与检查
Warehouse cleaning/pest control
仓库的清洁/虫害控制
Temperature monitoring 温度监测
Customer complaints 客户投诉
GDP Deficiencies – General
执行流通规范常中的见缺陷
Customer complaints not closed out in a timely manner 没有及时处理（了结）客户的投诉
No customer complaint log maintained
没有保留客户投诉记录
Service/calibration reports not reviewed
没有审核校准/ 维修报告
Pest control reports not reviewed
没有经过审核虫害控制报告
Calibration certs - acceptable error limit not specified 校准证明-没有具体规定误差限度
GDP Deficiencies – General
执行流通规范常中的见缺陷
Premises and Equipment 库房与设备
Unauthorised products supplied 发了未批准的产品
Premises maintained in an untidy/dirty condition
库房处于肮乱状态
Products not stored on pallets 产品没有用托盘储存
Inadequate segregation receiving / picking/ dispatch areas 接收/检料/发放区域没有适当隔离
Out of date/short dated stock in inventory
过期/短有效期产品没有库存清单
GDP Deficiencies – General
执行流通规范常中的见缺陷
Temperature Mapping 温度分布
Not performed
没有进行
Product stored in close proximity to unit heaters
产品近热源储存
Temperature probes not calibrated
温度传感器没有经过校准
GDP Deficiencies – General
执行流通规范常中的见缺陷
Premises and Equipment Cont’d 库房与设备(续)
Temperature excursions in cold room not investigated 冷库温度超出范围，没做调查
Data loggers not calibrated within operating range
没有对数据自动记录仪在其运行范围内对校准
MDA Drugs MDA药品
Inadequate control. Poor security
没有足够控制，安全性不良
GDP Deficiencies – General
执行流通规范常中的见缺陷
Discrepancies not adequately investigated
对差异情况没有适当调查
Dangerous storage practices 储存做法危险：
Rat poison stored over Baby Food Products
将毒鼠药储存在婴儿食品上
Organophosphorus compds stored over open
将有机磷化合物存放在上面
containers packaging components
容器包装成分。
GDP Deficiencies – General
执行流通规范常中的见缺陷
Deliveries to Customers 向客户发货
Cold storage units for delivery refrigerated products not validated
发货用冷藏产品的冷储存单元没有经过验证
Inadequate control re. ice packs
没有足够控制，如冰袋
Inadequate security of MDA drugs
对于MDA药品没有足够的安全性
GDP Deficiencies – General
执行流通规范常中的见缺陷
Returns 退货
No SOP Re. return of product to saleable stock
将退货产品到销售仓库无SOP
Personnel not trained Re. checking returned goods
没有对人员进行退回货物检查的培训
GDP Deficiencies – General
执行流通规范常中的见缺陷
Self Inspection 自检
No SOP defining Self Inspection
没有SOP来规定自检
Regular inspections not performed
没有进行定期检查
Reports not issued 自检无报告
Follow up actions not documented 跟踪措施无记录
Log of inspections not maintained
没有保存检查记录
GDP Deficiencies – General
执行流通规范常中的见缺陷
Current GDP Guideline 现行GDP指南
Guidelines on GDP of Medicinal Products for HumanUse (94/C 63/03) 人用药品流通管理规范(94/C 63/03)
since 1994 从1994年开始
out dated 已过期
limited scope, not detailed, no clear guidance
范围狭，不详细，缺乏明确的指导性
not reflecting current activities observed in wholesale distribution 不能反映现行药品流通的相关活动
Developments – new guidelines
制订-新的指南
Complex distribution networks where all players not wholesale distributors as defined in Directive 2001/83/EC
在复杂的药品流通网络中的各种角色，并非都是 2001/83/EC号法令中定义的批发商
This leads to inconsistencies in MS with respect to licensing and control of . virtual wholesalers, outsourcing activities, brokers, transportation
这在药品销售中，导致虚拟的批发商、外部采购活动、中间商、运输企业发放许可证及管理等方面的矛盾
Why a new guideline?
为什么要一个新指南?
New legislative requirements arising from proposal from Commission (identification of GDP requirements and obligations for brokers, verification of suppliers). These need to be incorporated into GDP Guidelines
新立法要求来自委员会的提议(鉴别药品流通的要求以及中间商，各供应企业的义务)，这需整合到GDP指南中
Lack of harmonisation –different procedures/formats at Community level and international level
缺乏协调–在欧盟层面与国际层面上有不同的程序/格式
Why a new guideline?
为什么要一个新指南?
Computerised systems 计算机化的系统
Management of contract arrangements
委托管理
Transparency in supply chain 供应链透明度
Transportation 运输
Counterfeit controls 假药控制
Likely new components
可能的新的内容
Subject all actors in distribution chain to conditions of wholesaling (except pharmacies, retailers)
取决于所有分销链的参与者至批发商条件(除药房，零售商外)
More stringent verification of suppliers by wholesalers
批发商对供货商将会有更严格的检查
GDP Community database (EudraGDP)
药品流通欧盟数据库
Strengthen GDP compliance inspections:
强化药品流通的达标检查:
“Compilation of Community Procedures for GDP“
“欧盟将流通规程进行汇编”
Potential impacts 潜在影响
GDP Drafting Group Established 2008 (EMA)
欧盟药品管理局流通规范起草小组于2008年成立
Concept Paper on revision published –February 2009
修订的概念文件已于2009年2月公布
Deadline for Comments –May 2009
征求意见截止日期–2009年5月
Guideline on GDP 药品流通指南
well advanced 相当先进
Work in progress 工作进展
harmonised with WHO Guideline
与WHO指南相协调/一致
draft for public consultation expected Q2 2010
预期在2010年第2季度发布草案进行磋商
some clarifications / definitions pending
有一些定义/需澄清的问题待定
must await EU Directive 必须等候欧盟的法令
Layout of Guideline expected to mirror GMPs
预计指南的大体结构参照GMP的形式
Work in progress 工作进展
Procedures on 这类程序包括：
Inspection process 检查程序
Issue of GDP Certificate 签发药品流通规范GDP证书
Serious GDP non-compliance 严重违反药品流通规范
Training and qualification of Inspectors
检查员的培训与资质确认
Wholesale Distribution Authorisation format
批发商许可批准格式文件
GDP Inspection report format
药品流通规范检查报告格式
Likely amendment of Compilation of Community Procedures 可能修订欧盟程序汇编
Obligations for wholesalers distributing to third countries (import for export)
批发商对第三国的义务(进口用于出口)
Inspection process for brokers
检查中间商的程序
EudraGDP format Eudra药品流通格式文件
GDP Certificates format 药品流通证书格式
Non-conformance certificates 不达标证书
Future developments 前景
Impact on Wholesalers 影响到批发商
New detailed GDP Guidelines 有新的详细的药品流通指南
New chapters (Quality Risk Management, Validation of Computerised Systems, Deviations, Change Control)
会有一些新的章节(质量风险管理，计算机化系统验证，偏差，
变更控制)
New format of Wholesaler’s Authorisation
批准新批发商许可的格式
GDP Certificate after each inspection每次检查发GDP证书
Information uploaded onto EudraGDP
信息上传到 EudraGDP（欧盟药品流通数据库）
Future developments 前景
冷链管理-
温度分布及一般要求
Cold Chain - Temperature mapping and general requirements
the
compliance
group
Stan O’Neill
CPAPE 2011 年会
Why is Storage Important ?
为什么储存如此重要?
Storage is a critical parameter in maintaining the quality, safety and efficacy of a medicinal product
它是保持药品质量，安全性与有效性的关键参数
Stability of the Product 产品稳定性
Product must be stored in accordance with the requirements of its market authorisation
产品的储存必须符合上市许可规定的条件
General Aspects of Storage
储存总体方面
Documentation Requirements 文件要求
Protocol 方案
Study Results 研究结果
Report 报告
Temperature Mapping or Qualification Studies 温度分布或确认试验
Should Provide 确认试验应包括：
Aims and objectives of the study 试验的目标与目的
Critical and objective overview of the storage conditions 对储存条件作重要及客观的回顾
Key operational parameters under which the study is being conducted 所进行试验的关键运行参数
Key technical parameters employed for the study
试验采用的关键技术参数
Calibration of instrumentation 仪器/仪表的校准
Procedure for investigation of deviations 偏差调查程序
Mapping or Qualification Study Protocol
温度分布或确认确认试验
In addition should be 另外，还应考虑：
Prepared in advance of the study
试验前的准备工作
Incorporated within the company quality system
整合到公司的质量体系中
Signed off by the relevant personnel and third party (if relevant) prior to commencement of the study
由相关人员或第三方(如有)在试验前签发方案
Mapping or Qualification Study Protocol
温度分布或确认试验方案
All of the temperature monitoring data generated in the study should be presented
在试验中获得的所有温度监测数据应列出
Graphical presentation of the data should also be utilised as a summary aid 还应当采用图的形式将数据进行总结
Critical review of the data 将数据资料重点进行回顾审核
Deviations outside the defined requirements stated within the protocol should be clearly identified
不符合试验方案规定要求的偏差应明确区分
All analyses of the data should be clearly described
应明确详细地描述所有分析的数据
Results of the Mapping or Qualification Study 温度分布或确认试验结果
Provide an overview of the rationale for the protocol
报告应对试验方案的理由，作了回顾性说明
Describe the conduct of the study 描述所做的试验
Describe the findings of the study 描述试验的结果
Detail investigation of temperature excursions
对偏离要求的温度数据详细进行调查
Identify worst locations with respect to maintaining the required temperature range
鉴别/标出最难保持温度的位置
Report on the Mapping or Validation Study 温度分布或验证试验报告
Describe the impact of the study on the on-going monitoring system
在报告中描述所进行的试验对监测系统的影响
Incorporated within the company quality system
将试验报告整合入公司的质量系统
Signed off by the relevant personnel and third party (if relevant) on completion
试验结束后，由相关人员与第三方(如有)签发报告
Report on the Mapping or Validation Study 温度分布或验证试验报告
Cold Storage 冷藏
Defined as storage requirements for products requiring storage between 2-8⁰C
需在2-8℃之间储存的产品定义为冷藏产品
Frozen Storage 冷冻储存
Defined as the storage conditions for product requiring storage at temperatures typically –20℃ or below . certain blood products
通常要求在-20 ℃或更低温度下储存的产品定义为冷藏产品，例如血液产品
Cold/Frozen Storage
冷藏/冷冻储存管理
Cold Chain 冷链
Refers to the temperature conditions under which such products are maintained throughout the distribution chain
在药品流通/销售中，产品有此温度要求的所有环节统称冷链
Cold/Frozen Storage
冷藏/冷冻储存
Purpose of fridge temperature mapping study is to:-
冰箱温度分布研究的目的是：
Assess the capability of the fridge unit in maintaining the defined 2-8°C temperature range
评估冰箱保持设定的2-8℃温度范围的能力
Identify hot and cold spots 识别高温及低温点
Investigate the capability of the unit under extremes in environmental conditions
调查冷藏单元在最差环境条件下的能力
Fridge/Freezer Units: Temperature Mapping Studies 冷藏/冷冻单元：温度分布试验
Risk assessment to identify worst case storage locations with respect to temperature control
用风险评估来识别储存过程中温度最难控制的位置：
Examine effects of normal operation (Air flow from chiller units; Height; Doors)
调查(冷却单元的气流；高度；门)正常运行时的影响
Extensive coverage of all storage areas
所有储存区域均应复盖
Capacity 考察冷藏/冷冻能力
Fridge/Freezer Units: Temperature Mapping Studies 冷藏/冷冻单元：温度分布试验
Simulation of the product temperatures within the load 模拟实际产品装载的温度
Effects of repairs 对冷藏/冷冻效果进行调整
Modifications in layout 或调整装载的布局
Opportunity to assess the capability of the unit in the event of powering down
创造条件，评估电源/动力故障情况下，设备的冷藏/冷冻能力
Fridge/Freezer Units: Temperature Mapping Studies 冷藏/冷冻单元：温度分布试验
Many Types Available 有许多类型
Max/min thermometers (minimum requirement)
最高/最低温度计(最低要求)
Electronic continuous recording temperature devices
电子温度连续记录装置
Portable Data Loggers
便携式手动记录仪
Temperature Monitoring Devices
温度监测装置
Continuous monitoring system 连续监测系统
Coverage of the storage area 覆盖储存区域
Coverage of self-contained storage areas
覆盖隔离式储存区域
Monitoring of worst-case locations identified by the temperature mapping study
对在温度分布试验中识别的最差位置进行监测
Frequency of temperature reading and recording
温度读数与记录应有适当的频率
Fridge/Freezer Temperature Monitoring 冷藏/冷冻温度的监测
Type of instrumentation (accuracy of +/⁰C)
仪器类型(准确度+/⁰C)
Use of product temperature monitoring
用于产品温度监测
Alarm System 报警系统
Effects of Normal Operation 正常运行的效果
Out of Hours Response 对非正常运行的响应
Tested 进行测试
Fridge/Freezer Temperature Monitoring 冷藏/冷冻温度的监测
Annually 每年校准
Against a certified, traceable reference standard
用经过鉴定的，具有可追踪的参照标准进行校准（对照）
Records of calibration should be maintained
应保存校准记录
Calibration 校准
Procedure for temperature recording should be documented 应有书面的温度记录的规程
Format of the records 记录有规定的格式
Review 有人审核
Independent review by the person responsible for the storage area 储存区责任人进行独立审核
Procedure for notification of excursions outside of specified limits 有温度偏离规定限度的通报程序
Investigation of excursions, consideration of the impact on product, and implementation of corrective actions
调查温度偏离，考虑其对产品的影响，实行纠偏措施
Temperature Recording 温度记录
Considerations in Selecting a Transportation System
选择一个运输系统应考虑的问题：
Nature & Size of the load 所装载的性质与大小
Temperature control requirements of the load
装载对温度的控制要求
Method of transportation 运输方法
Duration of transportation 运输时间
Local seasonal temperatures 地区不同季节的温度
情况
Cold Storage Transportation Systems
冷藏运输系统
Small Volume Systems 小容量系统
Chill packs may also be incorporated
可考虑采用冷却袋
May be of different sizes to incorporate smaller, medium, and larger volumes with the relevant capacity range
可能需根据能力来考虑大、中、小规格的不同组合
Typically suitable for smaller volume loads where the transit times are of limited duration . deliveries from a wholesaler to a pharmacy
通常适用于小量药品的运输，如从一个批发仓库发往药房的短距、短时运输
Small Volume Transportation Systems
小量运输系统
Qualification 确认
The system should be qualified to demonstrate its ability to maintain the required product temperature storage conditions
系统应经过确认，证实其保持产品储存温度的能力
Qualification should take into account
确认应当考虑以下因素：
Maximum transit times 最长运输时间
Minimum and maximum packaging capacities
最大、最小包装的装货能力
Operational Issues 运行问题
Maximum seasonal variation in temperatures
季节的最大温差变化
Packaging configuration for the systems
该系统中包装的配置
Required freezing times for the ice packs and cooling times for the chill packs
冰袋所需冷冻时间及冷却袋所需的冷却时间
Conditioning time for the ice packs
冰袋能起作用的持续时间
Operational Issues 运行问题
The system should be used in accordance with the parameters utilised in the qualification study
应按在确认试验中采用的参数要求使用系统
Additional requirements to support use of the system include:- 系统其它辅助性使用的要求包括：
Rotation and control of the ice packs and chill packs
冰袋与冷却袋的周转与控制
Corrective actions in the case of goods having been transported outside of the required temperature range 在货运过程中超出规定温度范围时的纠正措施
System In-Use 系统的使用
Labelling 标签/标签
All operational aspects should be proceduralised
系统所有的运行情况应当按规程处理
Temperature monitoring within the load
在装载中，监测温度
Training 对人员进行培训
System In-Use 系统的使用
Refrigerated transport vehicles or transportation containers which incorporate a chiller unit.
带制冷单元的冷藏车或集装箱
Suitable for large volume loads where the transit times are prolonged in duration
适用于货运量大、运输时间长时的装载
May be used as a primary or secondary means of environmental control
可用于一级或二级（直接或间接）环境控制手段
Cold Storage: Large Volume Transportation Systems 冷藏：大容量运输系统
Mapping to determine hot/cold spots with respect to storage. 用温度分布来确定储存区的高温及低温点
Qualification 确认
Consideration should be given to 应考虑以下内容：
Ensuring the air flow within the refrigeration unit 保证冷藏单元内空气流动
Capacity of the load 装载能力
Configuration of the load 装载配置/结构
Orientation of product with respect to the chiller and
air circulation units
根据制冷机及空气循环情况，堆放产品
Operational Issues 运行问题
System In-Use 系统的使用
Temperature Monitoring of the refrigeration unit.
对冷藏单元要监测温度
Use of temperature monitoring within the load.
监测装载的温度
The system should be used in accordance with the parameters utilised in the mapping & qualification studies.
应按在温度分布与确认试验中获得的参数使用系统
All operational aspects should be proceduralised.
所有运行情况均应有程序化的管理
Training 培训
Operational Issues 运行问题
Can a wholesaler release returned medicinal products requiring cold-chain storage back to saleable stock?
退回销售仓库需要冷链储存药品，批发商可以放行吗?
Question 问题
Cold chain products may only be returned to saleable stock where there is no reasonable possibility that the chain has been compromised.
只有当无适当的理由认为冷链受到损害情况下，冷链产品方可退回到销售仓库
The wholesaler should define strict criteria for accepting cold chain returns based on either of the following:-
批发商应根据以下情况，严格规定冷链产品退货的可接受标准：
Answer 回答
The use of a unique monitoring system attached to the product, which would demonstrate whether the product has been stored outside refrigerated conditions. (Note: This is Possible!)
在产品上使用唯一的监测系统，证明产品的冷储是否已经超越冷藏条件（译注：指有可靠的监测设备，证明冷藏条件是否受到不利影响，确有这类监测仪器!）
Answer 回答
The entire process is validated to include delivery to the customer, opening of packaging, examination of the product, return of the product to the packaging, collection by the courier or transporter and return to the distribution site refrigeration system.(Note: This is not possible!!)
整个过程经过验证，包括发运到客户，打开包装，检查产品，将产品返回包装，接收送货或运输商退回分销点的冷藏系统（注：这是不可能的!!）
Answer 回答
第一条：如帐货不符。
*
MS=member state? 或medicine sales? 不明确？
*
*
*
*
*
*
*
*
*
最后二句子：一是正常运行的效果；二是什么，内容不明确，要问？
