Medical network - December 30, according to the general administration of the state food and drug supervision and administration on modifying < drug management quality management > decision "(the state food and drug supervision and administration of administration makes no. 28), on the published < drugs management quality management standard > refrigerated, frozen storage and transportation of drug management, and other five announcement of appendix of 38 (2013) to make the following changes:
One, will be "appendix 2 drug-handling enterprise computer system" article 1 is amended as: "drug-handling enterprise shall set up and appropriate to the scope of business and business scale of computer system (hereinafter referred to as" system "), real time control and record the drug management each link and the whole process of quality management, and is in line with the drug traceability implementation conditions."
Second, will "appendix 3 temperature and humidity automatic monitoring" article 3 is amended as: "the system of temperature and humidity data measurements shall be in accordance with the relevant provisions of the article eighty-three of the" specification "setting.
System should be automatically generated record temperature and humidity monitoring, including temperature, humidity value, date, time, location of measuring points, the reservoir or transport category, etc. "
Three, will be "appendix 4 drugs receiving and acceptance" article 7 is amended as: "drug quarantined area and acceptance of pharmaceutical equipment, shall meet the following requirements:
(a) quarantined area have obvious signs, and effectively separated from other areas;
(2) the quarantined area conform to the requirements of the quarantined drug storage temperature;
(3) special quarantined area, set up special management of drugs and conform to the requirements of the safety control;
(4) keep the acceptance facilities clean and shall not be contaminated drugs. "
Four, delete "appendix 4 drugs receiving and acceptance" article 18.
Five, the appendix 4 drugs receiving and acceptance of the "article 19 is amended as:" enterprises shall, in accordance with the relevant provisions of the specification, pharmaceutical straight, can entrust purchase unit for drug inspection. Purchase unit shall be in strict accordance with the specification requirements acceptance drugs, establish special straight drug acceptance records. Acceptance on the day of acceptance shall be record the relevant information to direct the enterprises."
According to the above content, administration of the state food and drug supervision and administration of refrigerated, frozen storage and transportation of drug management, and other five appendix has made the corresponding modification, and promulgated anew. |
