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CFDA revises 5 items in GSP appendix


Medical Network December 30th According to the "Decision of the State Food and Drug Administration on Amending the" Good Manufacturing Practices "(State Food and Drug Administration Order No. 28)," On the Issuance of "Good Manufacturing Practices" The Announcement of 5 Appendixes for Storage and Transportation Management of Refrigerated and Frozen Drugs (No. 38, 2013) made the following amendments:
I. Article 1 of the "Appendix 2 Computer System for Pharmaceutical Trading Enterprises" was amended to read: "A pharmaceutical trading enterprise shall establish a computer system (hereinafter referred to as a system) that is compatible with the scope and scale of its operations, and shall be capable of controlling and recording all aspects of pharmaceutical operations in real time. And quality management throughout the process and in compliance with the implementation conditions for drug traceability. "
2. Amend the third item of “Appendix 3 Automatic Monitoring of Temperature and Humidity” to read: “The measured values of the temperature and humidity data of the system shall be set in accordance with the relevant provisions of Article 83 of the Code.
The system should automatically generate temperature and humidity monitoring records, including the temperature value, humidity value, date, time, measurement point location, reservoir area or transportation vehicle category. "
3. Amend Article 7 of "Appendix 4 Drug Receipt and Acceptance of Drugs" to read: "The area where drugs are to be inspected and the facilities and equipment for acceptance of drugs shall meet the following requirements:
(1) The area to be tested is clearly marked and effectively separated from other areas;
(2) The area to be tested meets the storage temperature requirements of the drug to be tested;
(3) Set up a special area for drug testing under special management and meet the requirements of safety control;
(4) Keep the inspection facilities and equipment clean and not contaminate drugs. "
4. Delete Article 18 of "Appendix 4 Receipt and Acceptance of Drugs".
5. Article 19 of "Appendix 4 Receipt and Acceptance of Drugs" was amended to read: "If an enterprise conducts direct drug adjustments in accordance with the relevant provisions of the" Specifications ", it may entrust the purchaser to conduct drug acceptance. The purchaser shall strictly follow The "Requirement" requires the acceptance of drugs and the establishment of a special direct-adjusted drug acceptance record. On the day of acceptance, the relevant information of the acceptance record shall be passed to the directly-adjusted enterprise. "
Based on the above, the State Food and Drug Administration has revised the five appendices, including refrigerated and frozen drug storage and transportation management, and republished them.