【正文】 美國食品藥品管理局 GMP 檢查程序 指導(dǎo)手冊綱 要 公布日期： 2/1/2020 由 FDA 2438(7/92)提供 1 題目： 藥品生產(chǎn) 檢查 實施日期 2/1/2020 完成日期 繼續(xù) 數(shù)據(jù)報表 產(chǎn)品編號 產(chǎn)品 /分配編碼 所有人用藥 行業(yè)編號： 50， 5456， 59， 6066 國內(nèi) /國外檢查： 56002 56002A 無菌產(chǎn)品生產(chǎn) 56002B 重新包裝和重貼標(biāo)簽 56002C 放射性藥物 56002E 壓縮藥用氣體 56002F 原料藥 FIELD REPORTING REQUIREMENTS 現(xiàn)場報告要求 Forward a copy of each Establishment Inspection Report (EIR) for inspections classified as OAI due to CGMP deficiencies as part of any regulatory action remendation submitted to HFD300. For all inspections that result in the issuance of a Warning Letter, forward an electronic copy of each letter to the Division of Manufacturing and 美國食品藥品管理局 GMP 檢查程序 指導(dǎo)手冊綱 要 公布日期： 2/1/2020 由 FDA 2438(7/92)提供 2 Product Quality, Case Management and Guidance Branch (HFD325). An account has been established to receive copies of Warning Letters. The account address is CDERCGMPWL. 根據(jù) CGMP 缺陷提出的指定的正式行為（ OAI）進行分類檢查后提出的 工廠檢查報告（ EIR） ，其復(fù)印件要轉(zhuǎn)發(fā)一份呈交到 HFD300，作為規(guī)范行為建議的一部分。對于檢查后發(fā)出警告信的情況，每封信的電子版都要轉(zhuǎn)發(fā)到生產(chǎn)和產(chǎn)品質(zhì)量部門，個案管理和指導(dǎo)部門（ HFD325）。專門建立了一個 賬戶接收警告信。該帳戶 地址是 CDERCGMPWL. This program provides guidance in evaluating pliance with CGMP requirements. As soon as the District bees aware of any significant inspectional, analytical, or other information developed under this program that may affect the agency39。s new drug approval decisions with respect to a firm, the District should report the information immediately according to current FACTS procedures. This includes filing OAI notifications and removing the notifications. 本綱要闡述了評估 CGMP遵守情況的方法指南。檢查官根據(jù)該綱要進行檢查，一旦發(fā)現(xiàn)該廠重大的檢查，分析或其它信息可能影響其新藥申請批準(zhǔn)時，應(yīng)立即根據(jù)當(dāng)前 FACTS程序提呈報告，包括整理 OAI通知和撤銷該通知。 However, if information is encountered pertaining to inadequate postapproval reporting (Annual Reports,Supplements, Field Alert Reports, Adverse Drug Experience Reports, etc.) the information should be described in accordance with directions provided in those applicable pliance programs and under 但是，如果查出的信息與不恰當(dāng)?shù)氖潞笈鷾?zhǔn)報告（年終報表，補充， 現(xiàn)場警告報告 ，藥物不良反應(yīng)報告等）有關(guān)，則描述這些信息時要與有關(guān)的應(yīng)用上需要遵守的條款一致，并在工廠檢查報告（ EIR）內(nèi)有獨立的標(biāo)題進行說明。 美國食品藥品管理局 GMP 檢查程序 指導(dǎo)手冊綱 要 公布日期： 2/1/2020 由 FDA 2438(7/92)提供 3 separate captions in the EIR. Data system information about these inspectional activities should be reported using applicable separate PAC(s). Expansion of coverage under these programs into a CGMP inspection must be reported under this pliance program. 采用實 用的單獨 PAC(s)，把這些檢查行動以數(shù)據(jù)系統(tǒng)信息的方式進行報告。如果要把這些檢查項目擴大成一個 CGMP 檢查，則必須要根據(jù)本需遵守條例提出報告。 The Districts are requested to use this revised pliance program for all GMP inspections. 要求檢查官以該修訂的需遵守條例為準(zhǔn)，進行 一切 GMP檢查。 PART I – BACKGROUND 第一部分－背景知識 A primary mission of the Food and Drug Administration is to conduct prehensive regulatory coverage of all aspects of production and distribution of drugs and drug products to assure that such products meet the 501(a)(2)(B) requirements of the Act. FDA has developed two basic strategies: FDA的主要使命是對藥物和藥品生產(chǎn)和銷售的各個方面進行全面的法規(guī)引導(dǎo)，以確保這些產(chǎn)品達到 法案 501(a)(2)(B)的要求。 FDA制定了兩個基本策略： 1) evaluating through factory inspections, including the collection and analysis of associated samples, the conditions and practices 美國食品藥品管理局 GMP 檢查程序 指導(dǎo)手冊綱 要 公布日期： 2/1/2020 由 FDA 2438(7/92)提供 4 under which drugs and drug products are manufactured, packed, tested and held, and 通過工廠 檢查進行評估，包括收集和分析相關(guān)樣品，藥物和藥品生產(chǎn)、包裝、檢驗 和質(zhì)量控制的條件和實踐，以及 2) monitoring the quality of drugs and drug products through surveillance activities such as sampling and analyzing products in distribution. 通過銷售時產(chǎn)品取樣和分析等監(jiān)督行為，對 藥物和藥品質(zhì)量進行監(jiān)督。 This pliance program is designed to provide guidance for implementing the first strategy. Products from production and distribution facilities covered under this program are consistently of acceptable quality if the firm is operating in a state of control. The Drug Product Surveillance Program () provides guidance for the latter strategy. 本需遵守條例對第一條策略提供實施指南。如果工廠的運行處于控制狀態(tài)下，則達到本條例要求的產(chǎn)品生產(chǎn)和銷售能夠保證始終達到質(zhì)量合格標(biāo)準(zhǔn)。而 藥品監(jiān)督條例 （ CP ）負責(zé)對第二條策略提供實施指南。 The inspectional guidance in this program is structured to provide for efficient use of resources devoted to routine surveillance coverage, recognizing that indepth coverage of all systems and all processes is not feasible for all firms on a biennial basis. It also provides for followup pliance coverage as needed. FDA意識到每兩年對所有系統(tǒng)和過程全面檢查一次并不是對所有公司都切實可行，因此該綱要中的檢查指南旨在為日常監(jiān)督提供夠用的資源。除此之外還根據(jù)需要提供進一步的需要遵守的條例。 美國食品藥品管理局 GMP 檢查程序 指導(dǎo)手冊綱 要 公布日期： 2/1/2020 由 FDA 2438(7/92)提供 5 PART II IMPLEMENTATION 第二部分－實 施 OBJECTIVES 目標(biāo) The goal of this program39。s activities is to minimize consumers39。 exposure to adulterated drug products. Under this program, inspections and investigations, sample collections and analyses, and regulatory or administrative followup are made: 實施 本程序 的目的是為了最大限度的減少消費者買到 假冒偽劣 藥品的可能性， 要求遵照本 程序進 行檢查和調(diào)查，樣品收集和分析以及進一步 的 法規(guī)和管理： 1) to determine whether inspected firms are operating in pliance with applicable CGMP requirements, and if not, to provide the evidence for actions to prevent adulterated products from entering the market and as appropriate to remove adulterated products from the market, and to take action against persons responsible as appropriate。 判斷接受檢查的工廠的運作是否 符合 CGMP的要求，如果不 符合 CGMP要求，要提供采取措施阻止不合格的產(chǎn)品進入市場 的證據(jù) ，相應(yīng)把這些產(chǎn)品從市場上撤回，并對責(zé)任人進行相應(yīng)處理； 2) to provide CGMP assessment which may be used in efficient determination of acceptability of the firm in the preapproval review of a facility for new drug applications。 提供 CGMP評估，用來有效判斷公司進行新藥申 報 時工廠通過預(yù)批評審的可行性。 美國食品藥品管理局 GMP 檢查程序 指導(dǎo)手冊綱 要 公布日期： 2/1/20