Chinese Bureau of Drugs Supervision notifies donkey-hide gelatin and products and produces special examination

Chinese Bureau of Drugs Supervision notifies donkey-hide gelatin and products and produces special examination
Electricity of June 22 of www.chinanews.com supervises website's news of administration bureau according to national food medicines, national food medicines supervise the administration bureau issuing the notice a few days ago, determine to launch donkey-hide gelatin and products and produce special examination immediately nationwide. June 6, CCTV the intersection of news channel and " the Weekly Quality Report " expose specific enterprise pretend to be the intersection of donkey and skin, make fake and poor inside story of donkey-hide gelatin with cow hide, the intersection of horse skin and the intersection of leftover bits and pieces,etc. and inferior material, cause the social enormous response. The notice claims, every provincial food pharmaceuticals administration department should require donkey-hide gelatin and suck health food and medicines manufacturing enterprise of donkey-hide gelatin, strengthen the consciousness of person liable of quality first of the products, strictly observe relevant regulation and technical requirement, do not strengthen the quality control of production relaxing at all. It produces the intersection of raw materials and skin that donkey-hide gelatin uses to be must the intersection of donkey and skin, forbid, have and use other the intersection of animal and skin, process hides the intersection of trade and leftover bits and pieces and the intersection of deterioration and skin,etc.. The medicines manufacturing enterprise produces donkey-hide gelatin, must strictly observe " standardard management of quality of production of medicines " (GMP) Manage to raw materials, examining and supplier audits etc. several requirements. Produce and include donkey-hide gelatin preparation, should strictly control stocking up, strengthen supplier's audit, guarantee production and standard of material donkey-hide gelatin thrown accord with medicines GMP and " Chinese pharmacopoeia's " requirement. The manufacturing enterprise of health food should carry out " food safety law " and relevant regulation strictly, buy donkey-hide gelatin as raw materials, should strictly control stocking up, guarantee quality its accord with the regulations of " Chinese pharmacopoeia ", set up raw materials and buy recording and supplier's file, guarantee that can trace to the source to purchase with raw materials, the production process should accord with " the health food produces the norm well " (GMP) The requirement, guarantee product quality. The notice requires, every provincial food pharmaceuticals administration department should launch the special examination of the donkey-hide gelatin and products production of this area under one's jurisdiction. To the medicines manufacturing enterprise, should check enterprise stock donkey's leather true and false especially, carry out the test of raw materials strictly and stipulate whether carry on strict audit to the raw materials supplier according to stipulated time and requirement, whether produce according to the fixed craft. Should supervise and destroy miscellaneous cover and inferior cover picked out. To the health food manufacturing enterprise, should food production supervise at ordinary times and manufacturing enterprise the intersection of person who add and relevant job requirementses of special examination implement completely illegally about launch health food about strengthen health care according to State Bureau One is supervised and inspected, check the production of material of donkey-hide gelatin, purchases and fulfils requirements especially, whether the production process accords with the health food GMP requirement, product quality is qualified. The notice emphasizes, to the question found while supervising and inspecting, demand to rectify and improve and supervise and implement immediately without exception; The products of the potential safety hazard, suspend production and sales without exception, and take the measure of information notifying, lower shelf, ordering to recall,etc. to having. To throwing the medicines manufacturing enterprise producing donkey-hide gelatin of material with the non- donkey's skin, assert according to article 48 of " law of medicine management " without exception, punish according to article 74 and 76, and is supervised and destroy all products involved; Of a serious nature, revoke " medicines production licence "; According to " two high judicial explanation " Relevant for regulation,involve that criminal offense,it is last criminal liability not to should transfer by public security organ to in time. To throwing the manufacturing enterprise of health food producing donkey-hide gelatin of material with the non- donkey's skin, punish according to article 85 and 87 of " food safety law " without exception, ones that involve the criminal offense, should transfer to the public security organ and investigate criminal liability in time. In addition notify, require every provincial the intersection of food and pharmaceuticals administration department launch donkey-hide gelatin before will it be July 15 2010 and products produce send State Bureau by special inspection. State Bureau will organize supervising and guiding the inspection in right time, the inspection will be notified.

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