chinese-pharmacopoeia--national-standards(存儲版)
【正文】 反 GMP,擅變工藝，攙偽造假 不屬正常標(biāo)準(zhǔn)關(guān)注項目而應(yīng)作為違反有關(guān)規(guī)定認(rèn)定不合格 ? 制劑重點(diǎn)關(guān)注（ 1）降解產(chǎn)物（ 2）毒性雜質(zhì) ? 雜質(zhì)鑒定、檢測以及定量限原則，同 ICH Chinese Pharmacopoeia2022 (Excipients) 《 中國藥典 》 2022版 輔料 ? 1New General Chapter on Excipients ? 2Enlarge excipients monographs ? 3Strengthen the requirements ? 1— 新增”藥用輔料”通則： ? 2擴(kuò)大輔料收載品種 ? 3嚴(yán)格輔料標(biāo)準(zhǔn)要求 Chinese Pharmacopoeia 2022(General Notice) 《 中國藥典 》 2022版 凡例 ? To define the Specification consist of 3 parts: general notice + monographs + appendices ( enforceable to ChP amp。 National Standards 《 中國藥典 》 及國家藥品標(biāo)準(zhǔn) Chinese Pharmacopeia Commission 中國國家藥典委員會 Beijing Drug Administrative Law in China 《 藥品管理法 》 的有關(guān)條款 ? 《 Drug Administration Law 》effective as of Dec. 1, 2022 ? Article 3 The State develops both modern and traditional medicines to give full play to their role in prevention and treatment of diseases and in maintenance of health ? The State protects the resources of natural crude drugs and encourages the cultivation of Chinese crude drugs ? 《 藥品管理法 》 2022年 12月 1日實施 ? 第三條 國家發(fā)展現(xiàn)代藥和傳統(tǒng)藥，充分發(fā)揮其在預(yù)防、醫(yī)療和保健中的作用。國務(wù)院藥品監(jiān)督管理部門組織藥典委員會，負(fù)責(zé)國家藥品標(biāo)準(zhǔn)的制定和修訂 Drug Administrative Law in China 《 藥品管理法 》 的有關(guān)條款 ? Article 102 Drugs refer to articles which are used in the prevention, treatment and diagnosis of human diseases and intended for the regulation of the physiological functions of human beings, for which indications, usage and dosage are established ? Including Chinese crude drugs, prepared slices of crude drugs, traditional Chinese medicine preparations, chemical drug substances amp。 approved by SFDA ? Drug derived from animal tissues must ply with the requirements for virus sterilization ? Residue solvent shall be ply with the requirements in appendix ( equal to ICH ) ? To reduce animal tests if it could be replaced by the precise method ? 生產(chǎn)工藝應(yīng)
高考資料相關(guān)推薦
鄂ICP備17016276號-1