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发表于 2012-11-22 19:52:59
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Food and Drug Administration
?(Reporter Zhang Ran) Yesterday, the State Food and Drug Administration issued "to strengthen the relevant provisions of the supervision and management of pharmaceutical excipients (draft)" (hereinafter referred to as "draft"), to the public for comments. "Draft" to be used in the production of drugs in the pharmaceutical excipients according to the standard inspection. The pharmaceutical excipients used in the production and dispensing of pharmaceuticals, excipients and additives. The pharmaceutical excipients is an important part of drugs, can directly affect the quality and safety of drugs. "Draft" made it clear that the pharmaceutical preparations manufacturing enterprises is the responsibility of the quality of medicines, pharmaceutical preparations manufacturing enterprises must be of pharmaceutical production accessories used in strict control, and supplier audit. Medicinal materials purchased must be used in the production of drugs 0638. "Draft," stressed that the manufacturers of pharmaceutical preparations must be prescribed prescription process the production of drugs, if the change should be in accordance with the relevant provisions of the study, and to fulfill the formalities for change. "Draft" reference to the pharmaceutical excipients pharmaceutical raw materials management, and increased supervision: either the pharmaceutical excipients manufacturers to organize production in accordance with the "pharmaceutical excipients production quality management practices" to improve the production enterprise access threshold ; two excipients into different categories according to risk management, materials and production of high-risk enterprises, strict access system, and strengthen risk control; new drug with excipients and pharmaceutical preparations associated review, emphasizing the pharmaceutical manufacturers of new excipients inspection and audit responsibilities, and further tightened to further enhance the drugs are drugs with stationary sources, and technical requirements of the excipients; will enhance and improve the standard of the pharmaceutical excipients as the current focus, the quality of pharmaceutical preparations. The comments deadline is June 8. |
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