1、,the compliance group,Stan ONeill CPAPE 2011 年會,歐盟藥品藥品流通法規(guī),EU Regulations on Drug Distributions,Guidelines on Good Distribution Practice of Medicinal Products for Human UseArticle 10 EU Dir 92/25/EEC人用藥品流通質量管理指南 歐盟第92/25/EEC號法令第10款,Personnel 人員 Documentation 文件 Premises and Equipment 房屋與設備 Deliverie

2、s to Customers 向客戶交付 Returns 退貨 Self Inspections 自檢,Ensure products are authorised 保證產品經過批準 Storage conditions are observed (all times) 關注產品儲存條件(任何時候) Prevent contamination from other products 預防來自其它產品的污染 Ensure adequate turnover of products 保證足夠的產品流轉量 Deliver right products 交付產品正確無誤,Quality System

3、Operated by Wholesalers should 批發(fā)商的質量系統(tǒng)應,Right Address 發(fā)貨地址正確 Satisfactory Period 發(fā)貨斯讓用戶滿意 Provide tracing system for faulty products 具備追蹤系統(tǒng)，追蹤有問題的產品 Effective Recall Procedure 有效的召回程序,Quality System Operated by Wholesalers should 批發(fā)商的質量系統(tǒng),Appoint Management Representative - “Responsible Person”- ea

4、ch distribution centre 每個分銷中心須指定-“負責人”-即管理代表 Appropriately qualified 適當?shù)馁Y質 Implement and maintain Quality System 來實施與保持質量系統(tǒng) Key Personnel 關鍵人員 Appropriate ability and experience to guarantee products are properly handled 有適當?shù)哪芰εc經驗來保證產品正確處理,Personnel 人員,Training 培訓 Provide training for various GDP op

5、erations 提供不同GDP操作的培訓 Training programmes 培訓計劃 Maintain training records 保存培訓記錄,Personnel 人員,Procedures 程序 Written procedures should describe the different operations which may affect 應當有書面規(guī)程來描述不同的操作，它們可能影響： the quality of the products 產品質量 the distribution activity 分銷活動 Procedures for 有以下規(guī)程： - Rece

6、ipt and checking of deliveries 發(fā)送產品的接收/檢查 - Storage 儲存 Cleaning and maintenance of premises 貯存廠房的清潔與維護,Documentation 文件,Procedures Contd 程序(續(xù)) Recording of storage conditions 記錄儲存條件 Security on site or in transit 現(xiàn)場或運送安全 Withdrawal from saleable stock 從銷售倉庫撤回 Records of - orders 記錄 -定單 - returned pr

7、oducts - 退貨 Recall plans 召回計劃 Procedures for various operations should be approved, signed and dated by the Responsible Person 各種規(guī)程均應經過負責人的批準，簽字與簽發(fā)日期,Documentation 文件,Records 記錄 Made when each operation is taking place 每次操作時均應記錄 Activities and events are traceable 活動/事件均可追蹤 Readily available 方便查閱 Re

8、tained for 5 years at least 至少保留5年 Each purchase and sale 每次采購與銷售有： Date 日期 product/quantity 產品/數(shù)量 name and address of supplier/consignee 發(fā)貨企業(yè)/收貨人的名稱與地址,Documentation 文件,Records Contd 記錄(續(xù)) Transactions between 以下交易的記錄： (i) Manufacturers and Wholesalers 制造企業(yè)與批發(fā)企業(yè) (ii) Between Wholesalers 批發(fā)企業(yè)之間 ensu

9、re traceability of origin/destination products i.e. Batch numbers to identify suppliers and those supplied with medicinal products 能保證產品起點/終點的追蹤性，如用批號來識別供應商及其發(fā)的藥品,Documentation 文件,Suitable and adequate to ensure proper conservation/ distribution 適用并足以保證貯存/分銷正確無誤 Monitoring devices should be calibrat

10、ed 監(jiān)控裝置應當進行校準 Receiving 接收 Receiving bays protect deliveries 有保護收貨的區(qū)域 Receiving area separate from storage areas 收貨區(qū)域與儲存區(qū)域分開 Deliveries examined on receipt 在收貨時檢查產品 Damage 有無損壞 corresponds to the order 與定單是否相符,Premises and Equipment 庫房設施與設備,Storage 儲存 Medicinal products separate from other goods 藥品與

11、其它產品分開 Conditions specified - protect from light, moisture, below 25 規(guī)定條件-避光,防潮,低于25 Temperature monitoring documented 溫度監(jiān)測有記錄 Records reviewed regularly 定期審核記錄 Temperature Mapping. Storage areas/cold rooms 溫度分布、儲存區(qū)/冷庫,Premises and Equipment 庫房設施與設備,Ensure all locations within specific temperature r

12、ange 保證所有區(qū)域都在規(guī)定的溫度范圍內 25oC 2 - 8oC,Premises and Equipment 庫房設施與設備,Storage Facility 儲存設施 Clean 清潔 Free from litter, dust, pests 無廢棄物、灰塵、蟲害 Free from spillage or breakage 沒有溢出或損壞 Microcontamination 微生物污染 Cross contamination 交叉污染 Stock Rotation 庫存流轉 “First in First out” Regular checks “先進先出”定期檢查,Premis

13、es and Equipment 庫房設施與設備,Out of Date or Damaged Stock 將過期或損壞庫存 Quarantine 隔離/待檢 Destroy 銷毀,Premises and Equipment 庫房設施與設備,Authorised Wholesalers 批準的批發(fā)商 Persons authorised to supply Medicinal Products 經批準可從事藥品流通的人員 IMB will look randomly at customer list 愛爾蘭藥品管理局將在客戶清單中隨機抽查 Supply Document 提供的文件應有： D

14、ate 日期 Name and Pharmaceutical Form 名稱與藥品劑型 Quantity supplied 供應數(shù)量,Deliveries to Customers 向客戶發(fā)貨,Supplier and addressee 供應商以及地址 Name and address 名稱與地址 Product Shelf Life 產品有效期 Product dispatched must have a minimum defined shelf life remaining 所發(fā)送的產品必須具有所規(guī)定最短有效期,Deliveries to Customers 向客戶發(fā)貨,Transpo

15、rtation 運輸 Ensure that 保證： Identification is not lost 不丟失標識 Cross Contamination is avoided 避免交叉污染 Products are secure 產品安全 Breakage Height; Doors) 調查(冷卻單元的氣流；高度；門)正常運行時的影響 Extensive coverage of all storage areas 所有儲存區(qū)域均應復蓋 Capacity 考察冷藏/冷凍能力,Fridge/Freezer Units: Temperature Mapping Studies 冷藏/冷凍單元：

16、溫度分布試驗,Simulation of the product temperatures within the load 模擬實際產品裝載的溫度 Effects of repairs 對冷藏/冷凍效果進行調整 Modifications in layout 或調整裝載的布局 Opportunity to assess the capability of the unit in the event of powering down 創(chuàng)造條件，評估電源/動力故障情況下，設備的冷藏/冷凍能力,Fridge/Freezer Units: Temperature Mapping Studies 冷藏/

17、冷凍單元：溫度分布試驗,Many Types Available 有許多類型 Max/min thermometers (minimum requirement) 最高/最低溫度計(最低要求) Electronic continuous recording temperature devices 電子溫度連續(xù)記錄裝置 Portable Data Loggers 便攜式手動記錄儀,Temperature Monitoring Devices 溫度監(jiān)測裝置,Continuous monitoring system 連續(xù)監(jiān)測系統(tǒng) Coverage of the storage area 覆蓋儲存區(qū)域

18、 Coverage of self-contained storage areas 覆蓋隔離式儲存區(qū)域 Monitoring of worst-case locations identified by the temperature mapping study 對在溫度分布試驗中識別的最差位置進行監(jiān)測 Frequency of temperature reading and recording 溫度讀數(shù)與記錄應有適當?shù)念l率,Fridge/Freezer Temperature Monitoring 冷藏/冷凍溫度的監(jiān)測,Type of instrumentation (accuracy of

19、+/-0.5C) 儀器類型(準確度+/-0.5C) Use of product temperature monitoring 用于產品溫度監(jiān)測 Alarm System 報警系統(tǒng) Effects of Normal Operation 正常運行的效果 Out of Hours Response 對非正常運行的響應 Tested 進行測試,Fridge/Freezer Temperature Monitoring 冷藏/冷凍溫度的監(jiān)測,Annually 每年校準 Against a certified, traceable reference standard 用經過鑒定的，具有可追蹤的參照標

20、準進行校準（對照） Records of calibration should be maintained 應保存校準記錄,Calibration 校準,Procedure for temperature recording should be documented 應有書面的溫度記錄的規(guī)程 Format of the records 記錄有規(guī)定的格式 Review 有人審核 Independent review by the person responsible for the storage area 儲存區(qū)責任人進行獨立審核 Procedure for notification of e

21、xcursions outside of specified limits 有溫度偏離規(guī)定限度的通報程序 Investigation of excursions, consideration of the impact on product, and implementation of corrective actions 調查溫度偏離，考慮其對產品的影響，實行糾偏措施,Temperature Recording 溫度記錄,Considerations in Selecting a Transportation System 選擇一個運輸系統(tǒng)應考慮的問題： Nature & Size of t

22、he load 所裝載的性質與大小 Temperature control requirements of the load 裝載對溫度的控制要求 Method of transportation 運輸方法 Duration of transportation 運輸時間 Local seasonal temperatures 地區(qū)不同季節(jié)的溫度 情況,Cold Storage Transportation Systems 冷藏運輸系統(tǒng),Small Volume Systems 小容量系統(tǒng) Chill packs may also be incorporated 可考慮采用冷卻袋 May be

23、of different sizes to incorporate smaller, medium, and larger volumes with the relevant capacity range 可能需根據(jù)能力來考慮大、中、小規(guī)格的不同組合 Typically suitable for smaller volume loads where the transit times are of limited duration e.g. deliveries from a wholesaler to a pharmacy 通常適用于小量藥品的運輸，如從一個批發(fā)倉庫發(fā)往藥房的短距、短時運輸,

24、Small Volume Transportation Systems 小量運輸系統(tǒng),Qualification 確認 The system should be qualified to demonstrate its ability to maintain the required product temperature storage conditions 系統(tǒng)應經過確認，證實其保持產品儲存溫度的能力 Qualification should take into account 確認應當考慮以下因素： Maximum transit times 最長運輸時間 Minimum and max

25、imum packaging capacities 最大、最小包裝的裝貨能力,Operational Issues 運行問題,Maximum seasonal variation in temperatures 季節(jié)的最大溫差變化 Packaging configuration for the systems 該系統(tǒng)中包裝的配置 Required freezing times for the ice packs and cooling times for the chill packs 冰袋所需冷凍時間及冷卻袋所需的冷卻時間 Conditioning time for the ice pack

26、s 冰袋能起作用的持續(xù)時間,Operational Issues 運行問題,The system should be used in accordance with the parameters utilised in the qualification study 應按在確認試驗中采用的參數(shù)要求使用系統(tǒng) Additional requirements to support use of the system include:- 系統(tǒng)其它輔助性使用的要求包括： Rotation and control of the ice packs and chill packs 冰袋與冷卻袋的周轉與控制

27、Corrective actions in the case of goods having been transported outside of the required temperature range 在貨運過程中超出規(guī)定溫度范圍時的糾正措施,System In-Use 系統(tǒng)的使用,Labelling 標簽/標簽 All operational aspects should be proceduralised 系統(tǒng)所有的運行情況應當按規(guī)程處理 Temperature monitoring within the load 在裝載中，監(jiān)測溫度 Training 對人員進行培訓,Syste

28、m In-Use 系統(tǒng)的使用,Refrigerated transport vehicles or transportation containers which incorporate a chiller unit. 帶制冷單元的冷藏車或集裝箱 Suitable for large volume loads where the transit times are prolonged in duration 適用于貨運量大、運輸時間長時的裝載 May be used as a primary or secondary means of environmental control 可用于一級或二

29、級（直接或間接）環(huán)境控制手段,Cold Storage: Large Volume Transportation Systems 冷藏：大容量運輸系統(tǒng),Mapping to determine hot/cold spots with respect to storage. 用溫度分布來確定儲存區(qū)的高溫及低溫點 Qualification 確認 Consideration should be given to 應考慮以下內容： Ensuring the air flow within the refrigeration unit 保證冷藏單元內空氣流動 Capacity of the load

30、裝載能力 Configuration of the load 裝載配置/結構 Orientation of product with respect to the chiller and air circulation units 根據(jù)制冷機及空氣循環(huán)情況，堆放產品,Operational Issues 運行問題,System In-Use 系統(tǒng)的使用 Temperature Monitoring of the refrigeration unit. 對冷藏單元要監(jiān)測溫度 Use of temperature monitoring within the load. 監(jiān)測裝載的溫度 The system should be used in accordance with the parameters utilised in the mapping & qualification studies. 應按在溫度分布與確認試驗中獲得的參數(shù)使用系統(tǒng) All operational aspects should be proceduralised. 所有運行情況均應有程序化的管理 Training 培訓,Operational Issues 運行問題,Can a wholesaler release returned medicinal products requiri