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Ampoules Storage And Transportation Management Practices
Sep 20, 2017

Ampoules storage and transportation management practices
This section describes the Ampoules storage and transportation management practices may not be veterinary drug manufacturers said livestock Ampoules, in fact, no matter what type of Ampoules are shared.
Chapter 1 General Provisions
Article 1 This Regulation shall be formulated in accordance with the Regulations on the Administration of Ampouling and Vaccination (hereinafter referred to as the Regulations) to strengthen the safety and effectiveness of the Ampoules storage, transportation management, ensure the quality of Ampoules and ensure the vaccination.
Article 2 This Regulation shall apply to the management of Ampoules storage and transportation in the regulations.
Article 3 The disease prevention and control institutions, Ampoules production enterprises and Ampoules wholesale enterprises shall have professional and technical personnel engaged in the management of Ampoules. The vaccination units shall be responsible for the management of Ampoules. Disease prevention and control institutions, vaccination units, Ampoules production enterprises, Ampoules wholesale enterprises should be equipped with the safety of Ampoules storage, transport facilities and equipment, the establishment of Ampoules storage, transportation management system, good Ampoules storage and transportation work.
Article 4 The administrative departments of public health at all levels and the food and drug supervision and administration departments shall be responsible for the supervision and administration of the implementation of this Code.
Chapter 2 Management of Ampoules storage and transportation
Article 5 Ampoules production enterprises and Ampoules wholesalers shall, in addition to the documents provided for in accordance with Article 17 of the Regulations, provide information on the equipment, time and temperature records of Ampoules transportation when selling Ampoules. The disease prevention and control agency shall provide information on the equipment, time and temperature records of Ampoules transportation when supplying or distributing Ampoules.
Article 6 The drug prevention and control institution, the vaccination unit and the Ampoules wholesaler shall, when receiving or purchase the Ampoules, request and inspect the Ampoules production enterprise and the Ampoules wholesale enterprise to provide the supporting documents and materials stipulated in Article 5. Receipt should check the Ampoules transport equipment, time, temperature records and other information, and Ampoules varieties, dosage forms, approval number, quantity, size, batch number, validity, supply units, manufacturers and other content acceptance, The Meet the required Ampoules before receiving.
Article VII of the disease prevention and control institutions, vaccination units, Ampoules wholesale enterprises on the acceptance of qualified Ampoules, should be in accordance with its temperature requirements stored in the corresponding refrigeration facilities and equipment, according to Ampoules varieties, batch number code release.
Article 8 The disease prevention and control institutions, vaccination units, Ampoules production enterprises and Ampoules wholesalers shall sell, supply or distribute Ampoules according to the principles of first-come, first-out, first-in, first-out first-out.
Article 9 Ampoules production enterprises and Ampoules wholesalers shall regularly check and record the stored Ampoules. Found that the quality of abnormal or more than valid, etc., should be promptly taken to seize, suspend delivery and other measures, and timely report to the local food and drug supervision and management departments; received the report of food and drug supervision and management departments should be abnormal quality or expired Ampoules according to law Corresponding measures.
Article 10 The disease prevention and control institution and the vaccination unit shall regularly check and record the stored Ampoules and discover that the Ampoules with abnormal quality should stop the supply, distribution and vaccination immediately and promptly supervise the county-level health administrative departments and food and drug supervision Management report, not to deal with their own. The health administrative departments that have received the report shall promptly organize the disease prevention and control institutions and the vaccination units to take the necessary emergency measures and report to the higher health administrative departments. The food and drug supervision and administration departments that have received the report shall take appropriate corresponding Measures.
Article 11 The disease prevention and control institutions and the Ampoules stored by the vaccination units shall be disposed of in accordance with the provisions of the Regulations on the Administration of Medical Wastes when they are expired and fail due to natural disasters.
Article XII Ampoules production enterprises, Ampoules wholesale enterprises should be designated person responsible for Ampoules delivery, packing, shipping work. Before shipment should check the refrigerated transport equipment start and run state, to meet the requirements before they can be shipped.
Article 13 A refrigerated vehicle or an ampule truck equipped with a refrigerated equipment used by a disease prevention and control institution, an Ampoules manufacturer, Ampoules wholesaler shall be in compliance with the Ampoules storage requirements during transportation.
Article XIV of the Ampoules receipt, acceptance, inspection and other records in the library should be saved to more than two years of Ampoules valid for future reference.
Chapter 3 Temperature monitoring of Ampoules storage and transportation
Article 15 The disease prevention and control institutions, vaccination units, Ampoules production enterprises and Ampoules wholesalers shall, in accordance with the requirements of the People's Republic of China Pharmacopoeia (current edition), the Standard for Vaccination Practices, and the temperature requirements for the storage and transportation of Ampoules Ampoules storage and transportation work. For Ampoules that do not receive pharmacopoeia, store and transport according to the Ampoules instruction manual.