【正文】 以 從 少 數(shù)特定 產(chǎn)品 延伸至某一外形類別 的所有產(chǎn)品。 Reporting coverage for every profile class as defined in FACTS, in each biennial inspection, provides the most broadly resourceefficient approach. Biennial updating of all profile classes will allow for CGMP acceptability determinations to be made without delays resulting from revisiting the firm. This will speed the review process, in response to pressed time frames for application decisions and in response to provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). This will allow for Preapproval Inspections/ Investigations Program inspections and Postapproval Audit Inspections Program inspections to focus on the specific issues related to a given application or the firm’s ability to keep applications current. 在每兩年一次的檢查中 針對 FACTS定義 的每種外形 類 別的 報告， 提供了范圍最廣的資源有效 的 方案。這樣可以加速評審過程，有助于減少 申請 的批復時間并符合 FDA 1997食品 藥品 管理 現(xiàn)代化法案 （ 1997 FDAMA）的條款 。 The inspection is defined as audit coverage of 2 or more systems, with mandatory coverage of the Quality System (see system definitions below). Inspection options include different numbers of systems to be covered depending on the purpose of the inspection. Inspecting the minimum number of systems, or more systems as deemed necessary by the District, will provide the basis for an overall CGMP decision. 此檢查 要求 對兩個以上 系統(tǒng)進行 審 核 ，其中 質量體系（見下文對系 統(tǒng)的定義） 為必檢項目 。 檢查官 是選擇最少的系統(tǒng)，還是認為有必 要檢查更多的系統(tǒng)， 為 工廠 CGMP總 狀況的 判定 提供了 基礎。其間將注意力集中于 系統(tǒng)而 非 外形類別上可以提高檢查效率， 其原因在于這些 系統(tǒng) 通常 應 用于多種外形類別 中 。故檢查 所涉及范圍 能夠代表 公司生產(chǎn)的所有外形類別。 delays in approval decisions will be avoided because uptodate profile class information will be available at all times. 因為無須 對所有外形類別進行多次檢查，提高了 效率；并且由于 隨時 可以 獲取 最新的外形類別 資料 ，避免了批準過程的延遲。 如果 一個系統(tǒng) 是 適當 的， 應 能 滿足該 公司生產(chǎn)的所有外形類別 的要求 。調查員不必檢查每個外形類別的 物料系統(tǒng) 。 Under each system there may be something unique for a particular profile class: ., under the Materials System, the production of Water for Injection USP for use in manufacturing. Selecting unique functions within a system will be at the discretion of the lead investigator. Any given inspection need not cover every system. See Part III. 每個系統(tǒng)針對一個具體的外形類別都會有某些不同之處：例如在物料系統(tǒng)中 ，生產(chǎn)用 USP注射用水的 制備 。任何 檢查 均無須 檢查每個系統(tǒng)。 Complete inspection of one system may necessitate further follow up of some items within the activities of another/other system(s) to fully document the findings. However, this coverage does not constitute nor require plete coverage of these other systems. 對一個系統(tǒng)的全面檢查 過程中 ，可能 有必要 對另一個 或 幾個系統(tǒng)的某些項目進 行進一步 深入 檢查 。 C. A Scheme of Systems for the Manufacture of Drugs/Drug Products 藥物 /藥品生產(chǎn) 的 系統(tǒng) 劃分 A general scheme of systems for auditing the manufacture of drugs and drug products consists of the following: 為便于審核，常將藥物 /藥品的生產(chǎn)劃分為 以下幾個系統(tǒng)： 1. Quality System. This system assures overall pliance with cGMPs and internal procedures and specifications. The system includes the quality control unit and all of its review and approval duties (., change 美國食品藥品管理局 GMP 檢查程序 指導手冊綱 要 公布日期： 2/1/2020 由 FDA 2438(7/92)提供 12 control, reprocessing, batch release, annual record review, validation protocols, and reports, etc.). 質量體系 .該體系確保全面遵守 CGMP條例以及內(nèi)部的 程 序 和 標準 。）。參見 CGMP法規(guī) 、 美國聯(lián)邦法規(guī) 21卷 211部分 第 B, E, F, G, I, J, K條 。該系統(tǒng)包括有關 措施 及活動，為藥物和藥品生產(chǎn)提供適當?shù)奈镔|環(huán)境和資源。 建筑和 廠房 設 施及其維護； b) Equipment qualifications (installation and operation)。 and cleaning and validation of cleaning processes as appropriate. Process performance qualification will be evaluated as part of the inspection of the overall process validation which is done within the system where the process is employed。工藝性能確認作為總體工藝驗證 的一部分 在檢查時 進行評估， 并 在采用該工藝的系統(tǒng)內(nèi)進行； 并且， c) Utilities that are not intended to be incorporated into the product such as HVAC, pressed gases, steam and water systems. See the CGMP regulation, 21 CFR 211 Subparts B, C, D, and J. 不直接 進入產(chǎn)品 的 公用 設施，如 空調凈化系統(tǒng)、 壓縮氣體 、 蒸汽和水系統(tǒng)等。 2. Materials System. This system includes measures and activities to control finished products, ponents, including water or gases, that are incorporated into the product, containers and closures. It includes validation of puterized inventory control processes, drug storage, distribution controls, and records. See the CGMP regulation, 21 CFR 211 Subparts B, E, H,and J. 物料系統(tǒng) 。包括對電腦化 庫存控制過程，藥品 存儲，發(fā)貨 控制和記錄 的驗證 。 4. Production System. This system includes measures and activities to control the manufacture of drugs and drug products including batch pounding, dosage form production, inprocess sampling and testing, and process validation. It also includes establishing, following, and documenting performance of approved manufacturing procedures. See the CGMP regulation, 21 CFR 211 Subparts B, F, and J. 生產(chǎn)體系 該系統(tǒng)包括對藥物和藥品生產(chǎn)進行控制的 措施和活動 ，包括批配料，制劑生產(chǎn)，生產(chǎn)過程中 取樣和 檢驗和 生 產(chǎn)過程驗證。 參 見 CGMP法規(guī)， 美國聯(lián)邦法規(guī) 21卷 211部分 第 B, F,J,條 。 參 見 CGMP法規(guī)， 美國聯(lián)邦法規(guī) 21卷 211部分 第 B, G,J條 。 參 見 CGMP法規(guī)， 美國聯(lián)邦法規(guī) 21卷 211部分第 B, I,J,和 K條 。 把所有的子章節(jié)組織起來形成這六個合理 的 體系， 體現(xiàn) 藥品生產(chǎn)操作的總方案。s operation. Production, control, or distribution records required to be maintained by the CGMP regulation and selected for review should be included for inspection audit within the context of each of the above systems. Inspections of contract panies should be within the system for which the product or service is contracted as well as their Quality System. 一個系統(tǒng)的 組織 結構 和人員安排， 包括適當?shù)馁Y格認證和培訓，均 作為系統(tǒng) 運行的一部分進行評估。 如果因某 產(chǎn)品或服務 而與某公司有合同關系，則需檢查該公司質量系統(tǒng) ，以及在檢查 該產(chǎn)品和服務所歸屬的系統(tǒng) 時對該公司進行檢查 。 PROGRAM MANAGEMENT INSTRUCTIONS 程序管理指導 A. Definitions/定義 Inspections/監(jiān)督檢查 The Full Inspection Option 全面檢查選項 The Full Inspection Option is a surveillance or pliance inspection which is meant to provide a broad and deep evaluation of the firm39。s 美國食品藥品管理局 GMP 檢查程序 指導手冊綱 要 公布日期： 2/1/2020 由 FDA 2438(7/92)提供 16 CGMP pliance (., for new firms)。 or foll