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  CFDA Modifies 5 Items of GSP Appendix File

Medical Network - December 30th, according to the decision of General Administration of the State Food and Drug Administration on modifying <Good Supply Practice>"( no. 28 order of the State Food and Drug Administration), make amendments to < Good Supply Practice > regarding 5 Appendixes Announcements about the storage and transportation management of refrigerated and frozen drugs (No. 38 of 2013) as follows:

I.Change “Article 1 of Appendix 2: computer system of drug dealing enterprises " to: "drug dealing enterprise shall set up appropriate computer system matching its business scope and business scale (hereinafter referred to as" system "), can timely control and record each link and quality management of drug dealing, and keep in line with implementation conditions of the drug traceability.

II. Change “Article 3 of Appendix 3: automatic temperature and humidity monitoring to: "the measured value of system temperature and humidity data shall be set in accordance with the relevant provisions of Article 83 of GSP system.

The system shall automatically generate temperature and humidity monitoring records, including temperature value, humidity value, date, time, location of measurement point, storage area or type of transportation, etc."

III. Change “Article 7 of Appendix 4: the facilities and equipment of drug inspection area and tested drugs shall meet the following requirements:

1. The inspected area is clearly marked and effectively isolated from other areas;

2. The inspected area shall meet the requirements of storage temperature of inspected drugs;

3. Set up particular inspected area of special management, and meet the requirements of safety control;

4. Keep the inspection facilities and equipment clean and do not get the drugs contaminated.

IV. Delete “Article 18 of Appendix 4: drug receipt and acceptance”.

V. Change “Article 19 of Appendix 4: drug receipt and acceptance” to: "if an enterprise conducts direct drug dispatch in accordance with the relevant provisions of GSP system, it may entrust the purchasing unit to conduct drug acceptance and inspection. The purchasing unit shall strictly check and accept the drugs in accordance with the GSP requirements, and establish a special drug inspection record. The relevant information of the acceptance record shall be transmitted to the direct transferred enterprise on the same day of acceptance and inspection."

According to the above-mentioned points, the State Food and Drug Administration made corresponding amendments to the five appendixes, including the storage and transportation management of refrigerated and frozen drugs, and re-promulgated them.