【正文】 ? Collaborate with the sponsors to get the right information – test methods, validations, etc. – required for standard development 與發(fā)起方合作獲得標(biāo)準(zhǔn)開(kāi)發(fā)所必需的信息，包括測(cè)試方法，驗(yàn)證數(shù)據(jù)等 Where Are the Monographs Coming From 標(biāo)準(zhǔn)從何而來(lái) ? USP would like to work with more manufacturers from China USP希望與更多中國(guó)生產(chǎn)商合作建立標(biāo)準(zhǔn) Example: Pioglitazone Monograph in PF36（ 1） 舉例：吡格列酮各論 ,收錄于 PF36（ 1） Reference Standard Development 標(biāo)準(zhǔn)品開(kāi)發(fā) Material is tested and characterized through collaborative testing involving a minimum of three labs—industry, FDA, and USP (3 months) 物料在至少 3個(gè)實(shí)驗(yàn)室進(jìn)行聯(lián)合標(biāo)定 企業(yè)， FDA和 USP Bulk material is obtained from industry 從企業(yè)獲取原料 Data from the collaborative study are reviewed by USP staff scientists ( 1week) USP科學(xué)人員審核聯(lián)合標(biāo)定數(shù)據(jù) Compilation of collaborative study is reviewed and balloted by USP scientific teams (3 weeks) USP科學(xué)小組審核聯(lián)合標(biāo)定匯總數(shù)據(jù)并投票 Once approved, material subdivided, labeled amp。 – No further characterization required as primary standards. 作為法定標(biāo)準(zhǔn)品不需進(jìn)一步的標(biāo)定（直接使用） – FDA guidance requires testing of inhouse standard against a primary reference standard (USP or other). FDA指南要求內(nèi)部標(biāo)準(zhǔn)品要按法定標(biāo)準(zhǔn)品（ USP或其它）標(biāo)定。對(duì)效力、質(zhì)量或純度的判斷應(yīng)當(dāng)根據(jù)藥典中所設(shè)定的分析方法或測(cè)試而得到 ……” Section 501(a)(2)(B): ? A drug is adulterated if it is not manufactured in accordance with current Good Manufacturing Practices (cGMPs) 若藥品未按照 cGMP規(guī)范生產(chǎn)視為假藥 – cGMP regulations require testing of each batch of finished drug product to ensure that it meets defined specifications. cGMP法規(guī)要求最終產(chǎn)品每批檢測(cè)，以保證產(chǎn)品符合既定的標(biāo)準(zhǔn) Section 201(j): ? The term “official pendium” means the official United States Pharmacopeia . . . National Formulary, or any supplement . . .” 術(shù)語(yǔ) “official pendium” 意思是法定美國(guó)藥典 …國(guó)家處方集及其增補(bǔ)本 … FFDCA Requirements for Conformance to USP Documentary Standards ? Ultimately, the product must conform to the pendial standard. 最終， 制劑產(chǎn)品 必須符合藥典標(biāo)準(zhǔn)。 USP的建立 USP 全球分布 2022–2022 屆 專(zhuān) 家委 員 會(huì) 13 核心藥典項(xiàng)目 ? 《 美國(guó)藥典 國(guó)家處方集 》 (USP–NF) – 超過(guò) 4300個(gè)各論 – 225章通則 ? 《 食品化學(xué)法典 》 (FCC) – 超過(guò) 1000個(gè)各論 – 150 個(gè)通用測(cè)試章節(jié) ? 《 食品補(bǔ)充劑標(biāo)準(zhǔn) 》 – 綜合 USPNF和 FCC中的相關(guān)各論 – 提供檢測(cè)方法和標(biāo)準(zhǔn) – 提供綜合法規(guī)信息 FDA, 聯(lián)邦貿(mào)易委員會(huì)和產(chǎn)業(yè)組織 – 彩色顯微鑒別圖，化學(xué)結(jié)構(gòu)及色譜圖 ? 藥典論壇 ? 其他出版物 Type of Article 產(chǎn)品分類(lèi) Inclusion Criteria 收錄標(biāo)準(zhǔn) Therapeutics (drug substances, drug products, biologics) 治療性產(chǎn)品（原料藥，制劑，生物制品） USP: approved by US FDA 已被 FDA批準(zhǔn) Pending： submitted/intended to submit for FDA approval 已遞交 FDA進(jìn)行審批或準(zhǔn)備提交 FDA進(jìn)行審批的藥物 ‘NonUS’: approved by stringent regulatory authority other than FDA, for marketing outside USA 被 FDA之外其它嚴(yán)格的藥物管理機(jī)構(gòu)批準(zhǔn)，并在美國(guó)之外上市的藥物 Excipients 輔料 NF: listed on FDA’s Inactive Ingredients Database 收錄于 FDA的非活性成分?jǐn)?shù)據(jù)庫(kù) Dietary Supplements 食品和營(yíng)養(yǎng)補(bǔ)充劑 DSC: Listed by FDA as an ODI or NDI (old or new Dietary Ingredient) 被 FDA列入 ODI或 NDI Food Ingredients 食品成分 FCC: Food ingredients legally marketed in any country with a regulatory food safety agency