1、dosage form dru manufacturers CG MPs(10/93)FDA準(zhǔn)備工廠檢查指南guide to inspections of dosage form drug manufacturers-CGMP RSnote : this document is reference material for investigator s and other FDA personel。the document does not bind FDA，And does no confer any rights，privileges，benefits，or immunities for

2、on any person(s)注：本指南是FDA檢查及其員工的參考。本文檔不約束FDA，也不授予任何人任何權(quán)限、特權(quán)、利益或豁免。一.導(dǎo)言this document is intensed to be a general guide to inspections of dru manufacturers to determine their compliance with the drug CGMP RS . this guide shosome of these guides are :本文旨在提供整體指導(dǎo)，以確定藥品制造商是否符合藥品生產(chǎn)的cGMP規(guī)定。本指南應(yīng)與investigatio

3、n s operations manual，checked user guide(IOM)、其他藥物檢查指南和法規(guī)遵從性程序中的說明一起使用。IOM的第10章包含以下檢查指南列表：o guide to inspections of bulk pharmace utical chemicals。O API檢查指南o guide to inspections of high purity water systems。o高純系統(tǒng)檢驗指南o guide to inspections of pharmaceutical quality control laboratories。o藥物QC實驗室檢查指南o

4、 guide to inspections of micro biological pharmaceutical quality control laboratories。o微生物藥物QC實驗室檢查指南o guide to inspections of lyophilization of par enter als。o凍干針劑檢驗指南o guide to inspections of validation of cleaning processes。o清潔驗證確認(rèn)指南o guide to inspections of computerized systems in drug processin

5、g。o在制藥過程中計算機(jī)化的系統(tǒng)檢查指南o guideline on general principles of process validation。o流程驗證一般原則指南二.current good manufacturing practice regulations二.CGMP按壓cription vs. non-presscription處方藥和非處方藥all drugs must be manufactured in accordance with the current good manufacturing practices regulations otherwise they

6、are consired to be adulterationsrecords relative to prescription drugs must be readyy available for review in accordance with sec . 704(a)(1)(b)Of the FDC accordanceIf The product is an OTC drug which is covered by an NDA or anda，F(xiàn)DA may review，Copy and verify The records under ssec . 505(k)(2)the i

7、nvestigator should review these records as part of the inspection in determining the firms compliance with the Cgmp regulations .on rare occasions，A firm may refuse to allow review of OTC records stating they are not legally required to .while the firm may be under no legal obligation to permit r Ev

8、iew Of such records，This does not relieve the firm Of its statutory requirement to comment所有藥品的生產(chǎn)過程都要遵循cGMP原則。否則，根據(jù)FDC法令，501(a)(2)(B)被視為訂婚行為。要按照FDC法令704(a)(1)(B)審查，必須提供處方藥的記錄。如果藥物是NDA或ANDA范圍內(nèi)的OTC藥物，則FDA可以根據(jù)505(k)(2)進(jìn)行記錄的審核，復(fù)制和確認(rèn)。但是，如果OTC藥品未包括在FDA注冊申請中，則在按照Section 704 of the FDC規(guī)定執(zhí)行檢查時，工廠不會法律要求檢查人員提供

9、這些記錄。盡管如此，所有處方藥和OTC生產(chǎn)者都必須遵守cGMP的要求，包括相關(guān)記錄。檢查應(yīng)該將記錄檢查作為判斷制造商是否符合cGMP要求的一部分。有時，一些公司可能拒絕向OTC提供記錄，因為他們沒有法律要求這樣做。工廠沒有為審核提供這些記錄的法律義務(wù)，但這并不意味著需要符合501(a)(2)(B)cGMP法律要求的工廠，包括記錄保留要求。if a firm refuses review of OTC records，The investigator should determine by other inspection al means The extent of The firms com

10、pliance with cggsinspection al observations and findings t Hat CGMP RS are not being followwed are to be cited on a list of inspection al observations，F(xiàn)DA-483如果一家工廠拒絕對OTC記錄進(jìn)行審核，檢查者必須根據(jù)其他檢查方法確定該公司符合cGMP的程度。檢查處方藥和非處方藥物時，請將發(fā)現(xiàn)不符合cGMP的部分引用到檢查發(fā)現(xiàn)清單(FDA-483)中。組織和個人版21 CFR 211 subpart b組織和人員the firm must hav

11、e a quality control department that has the respons ibility and authority as described in the referenced CFR .the quality control depar Tment must maintain its in dependence from the production department，and its responsibilities must be in writing . OBB工廠必須有質(zhì)量管理部門，其責(zé)任和權(quán)限必須與CFR說明相匹配。QC部門必須與生產(chǎn)部門保持獨立，

12、其義務(wù)必須有書面規(guī)定。要從IOM中獲取公司聯(lián)系人和其他核心人員的姓名、職稱和個人責(zé)任，請執(zhí)行以下操作：In the drug industry，An employees education and training for their position has a significant impact on the production of a quality product . reprepoduct在制藥行業(yè)，員工的教育背景和職業(yè)培訓(xùn)對產(chǎn)品質(zhì)量有很重要的影響。報告和接收工廠是否有正式培訓(xùn)計劃的培訓(xùn)類型。培訓(xùn)必須有文檔記錄quality control must do product an

13、nual review on each dru manufactured，And have written annual review procedures . review these reports in detacturedinvestigate any failures。對于生產(chǎn)的每種藥品，QC必須進(jìn)行產(chǎn)品年度審查，并具備書面年度審查程序。仔細(xì)審閱這些報告。通過報告，很快就會知道生產(chǎn)工藝是否受到控制。報告應(yīng)提供在控制或成品測試中失敗的所有批和其他關(guān)鍵因素。調(diào)查所有的失敗。quality control must validate the manufacturing process for each dru manufactured . review and evaluate this data。質(zhì)量管理需要驗證藥品生產(chǎn)過程。復(fù)查和評估此數(shù)據(jù)。buildings and facilities21 CFR 211 subpart c建筑和工廠Review the construction，size，And location of pla