【正文】 20 由 FDA 2438(7/92)提供 6 3） to provide input to firms during inspections to improve their pliance with regulations。 and, 對(duì)接受檢查的公司提出建議，幫助該公司提高遵守法規(guī)的力度；并， 4） to continue FDA39。s unique expertise in drug manufacturing in determining the adequacy of CGMP requirements, Agency CGMP regulatory policy, and guidance documents. FDA繼 續(xù)其獨(dú)有的藥品生產(chǎn)上的專業(yè)技術(shù)，判 斷 CGMP要求的合理 性， FDA的 CGMP法規(guī)政策和指南 。 strategy 策略 A. Biennial Inspection of Manufacturing Sites (includes repackaging, contract labs, etc.) 對(duì)生產(chǎn)地點(diǎn)（包括重新包裝、簽約實(shí)驗(yàn)室 等）兩年檢查一次 Drugs and drug products are manufactured using many physical operations to bring together ponents and containers and closures into a product that is released for distribution. 在藥物和藥品生產(chǎn)過程中， 通過一系列 物理操作把各種成分 、容器以 及密封件加工成可以 放行 銷售 的產(chǎn)品。 Activities found in drug firms can be anized into systems that are sets of operations and related activities. Control of all systems helps to ensure the firm will produce drugs that are safe, have the identity and strength, and meet the quality and purity characteristics as intended. 美國(guó)食品藥品管理局 GMP 檢查程序 指導(dǎo)手冊(cè)綱 要 公布日期： 2/1/2020 由 FDA 2438(7/92)提供 7 制藥公司行為可以歸納為幾個(gè) 系 統(tǒng)，每個(gè)系統(tǒng)由一系列操作和相關(guān)的活動(dòng)組成 。通過對(duì)這些系統(tǒng)的控制， 有助于 確保公司按要求生產(chǎn)出安全、均一、有效 的產(chǎn)品，并且符合預(yù)定的 質(zhì)量和純度 要求 。 Biennial inspections (every two years) conducted under this program: FDA兩年進(jìn)行一次檢查（每隔兩年） 的目的在于 ： 1） reduce the risk that adulterated products are reaching the marketplace。 降低假冒偽劣 產(chǎn)品進(jìn)入市場(chǎng)的危險(xiǎn)性； 2) increase munication between the industry and the Agency。 增進(jìn)制藥行業(yè)和 FDA的交流； 3) provide for timely evaluation of new manufacturing operations in the firm。 and, 對(duì)公司的新 生產(chǎn)操作及時(shí)進(jìn)行評(píng)估；并， 4) provide for regular feedback from the Agency to individual firms on the continuing status of the firm39。s GMP pliance. 定期對(duì)這家公司提供反饋，告知對(duì)方遵守 GMP的狀況。 This program applies to all drug manufacturing operations. 本綱要適用于所有藥品生產(chǎn)操作。 美國(guó)食品藥品管理局 GMP 檢查程序 指導(dǎo)手冊(cè)綱 要 公布日期： 2/1/2020 由 FDA 2438(7/92)提供 8 Currently there are not enough FDA resources to audit every aspect of CGMP in every manufacturing facility during every inspection visit. Profile classes generalize inspection coverage from a small number of specific products to all the products in that class. This program establishes a systems approach to further generalize inspection coverage from a small number of profile classes to an overall evaluation of the firm. 目前 FDA沒有足夠的資源在每次檢查中對(duì)每個(gè) 藥廠進(jìn)行全方位 的 GMP審查。如果按照外形分 類 進(jìn)行檢查 ，其 檢查 范圍可以 從 少 數(shù)特定 產(chǎn)品 延伸至某一外形類別 的所有產(chǎn)品。本綱要建立了一個(gè)系統(tǒng) 方案，進(jìn)一步把檢查覆蓋范圍從少量外形類 別 延伸到對(duì)公司的總體 評(píng)估。 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?jī)赡暌淮蔚臋z查中 針對(duì) FACTS定義 的每種外形 類 別的 報(bào)告， 提供了范圍最廣的資源有效 的 方案。對(duì)所有外形 類 別兩年一次 的 更新，可以 判定 是否符合 CGMP的 要求，而 無須 推遲到 對(duì) 公司 進(jìn)行再次檢查后再作出判定。這樣可以加速評(píng)審過程，有助于減少 申請(qǐng) 的批復(fù)時(shí)間并符合 FDA 1997食品 藥品 管理 現(xiàn)代化法案 （ 1997 FDAMA）的條款 。 而且也有助于基于 批 準(zhǔn)前 檢 查 /調(diào)查程序 和 批準(zhǔn)后審核 檢查程序進(jìn)行的檢查 能夠集中于與某個(gè) 申請(qǐng) 有關(guān)的具體問題 或該公司的保持申請(qǐng)實(shí)時(shí)性美國(guó)食品藥品管理局 GMP 檢查程序 指導(dǎo)手冊(cè)綱 要 公布日期： 2/1/2020 由 FDA 2438(7/92)提供 9 的能力。 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(duì)兩個(gè)以上 系統(tǒng)進(jìn)行 審 核 ，其中 質(zhì)量體系（見下文對(duì)系 統(tǒng)的定義） 為必檢項(xiàng)目 。 根據(jù)檢查目的的不同選擇 的系統(tǒng) 數(shù)目也不同 。 檢查官 是選擇最少的系統(tǒng)，還是認(rèn)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(chǔ)。 B. Inspection of Systems/系統(tǒng)檢查 Inspections drug manufacturers should be made and reported using the system definitions and anization in this pliance program. Focusing on systems, rather than profile classes, will increase efficiency in conducting inspections because the systems are often applicable to multiple profile classes. 運(yùn) 用本 綱要 中 對(duì)系統(tǒng)的定義和組織方式對(duì)藥品生產(chǎn)方進(jìn)行檢查并作出報(bào)告。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(yīng) 用于多種外形類別 中 。 One biennial inspection visit will result in a determination of acceptability/nonacceptability for all profile classes. Inspection coverage should be representative of all the profile classes manufactured by the firm. 每?jī)赡暌?次 的 檢查 將 決定所 有 外形類別 是否具有可接受性 。故檢查 所涉及范圍 能夠代表 公司生產(chǎn)的所有外形類別。 美國(guó)食品藥品管理局 GMP 檢查程序 指導(dǎo)手冊(cè)綱 要 公布日期： 2/1/2020 由 FDA 2438(7/92)提供 10 The efficiency will be realized because multiple visits to a firm will not be needed to cover all profile classes。 delays in approval decisions will be avoided because uptodate profile class information will be available at all times. 因?yàn)闊o須 對(duì)所有外形類別進(jìn)行多次檢查，提高了 效率；并且由于 隨時(shí) 可以 獲取 最新的外形類別 資料 ，避免了批準(zhǔn)過程的延遲。 Coverage of a system should be sufficiently detailed, with specific examples selected, so that the system inspection oute reflects the state of control in that system for every profile class. If a particular system is adequate, it should be adequate for all profile classes manufactured by the firm. 對(duì)一個(gè)系統(tǒng)的覆蓋范圍應(yīng)盡量詳細(xì)說明，并列出具體案例，以便對(duì)該 系統(tǒng)檢查的結(jié)果 能反映該系統(tǒng)對(duì)每一外形類別的控制情況 。 如果 一個(gè)系統(tǒng) 是 適當(dāng) 的， 應(yīng) 能 滿足該 公司生產(chǎn)的所有外形類別 的要求 。 For example, the way a firm