General Administration of Food and Drug Administration: The Code of Quality Management of Drug Operations has been revised

In accordance with the Decision of the State Administration of Food and Drug Administration on the Amendment of the Code of Quality Management of Drug Operations (Order No. 28 of the State Administration of Food and Drug Administration), the Announcement of the Five Appendixes on the Issue of the Code of Quality Management for the Operation of Drugs, Refrigeration, Storage and Transportation Management of Frozen Drugs (No. 38 of 2013) To make the following changes:
1. To amend the first article of Appendix 2 To the Computer System of Pharmaceutical Business Enterprises to read: "Pharmaceutical enterprises shall establish computer systems (hereinafter referred to as systems) appropriate to the scope of business and the scale of operation, which shall be able to control and record all aspects of drug operations and the whole process of quality management in real time, and shall comply with the conditions for the retrospective implementation of pharmaceuticals." Article
3 of "Automatic monitoring of temperature and humidity in Appendix 3" shall be amended to state: "The measurement value of system temperature and humidity data shall be set in accordance with the relevant provisions of Article 83 of the Code." The system shall automatically generate temperature and humidity monitoring records, including temperature values, humidity values, dates, times, point locations, storage areas or transport categories.
3. Amend Article 7 of Appendix 4 Drug Receipt and Acceptance to: "The area to be examined and the facilities and equipment for the acceptance of medicines shall meet the following requirements:
(1) the area to be examined shall be clearly marked and effectively isolated from other areas;
(2) The area to be tested conforms to the storage temperature requirements of the drugs to be tested;
(3) sets up a specially managed area for the drug to be examined and meets the requirements of safety control; and
(4) keeps the equipment of the acceptance facility clean and shall not pollute the drugs. Article
18 of Appendix 4 Drug Receipts and Acceptances.
. Article 19 of Appendix 4 Drug Receipt and Acceptance shall be amended to state:
If an enterprise conducts a direct adjustment of a drug in accordance with the relevant provisions of the Code, it may entrust the purchasing unit to carry out the acceptance of the drug." The purchasing unit shall accept the drugs in strict accordance with the requirements of the Code and establish a special record of the acceptance of direct drugs. On the day of acceptance, the relevant information about the acceptance record shall be passed on to the direct-adjustment enterprise. This
shall take effect as of the date of publication. Five appendix documents, such as storage and transportation management of refrigerated and frozen medicines, computer systems of pharmaceutical operating enterprises, automatic monitoring of temperature and humidity, receipt and acceptance of medicines, and verification management, are revised and re-published in accordance with this announcement. (Chinese Food and Drug News)