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嘉峪檢測(cè)網(wǎng) 2025-03-05 20:29
近日，F(xiàn)DA發(fā)布了對(duì)Granules India Limited的警告信，其中披露的關(guān)于設(shè)備清潔交叉污染、數(shù)據(jù)完整性等嚴(yán)重的GMP問題，如下：
檢查人員在用于生產(chǎn)成品藥物的非專用設(shè)備的多個(gè)管道觀察到了嚴(yán)重污染。雖然安裝了過濾器以防止污染，但清潔和維護(hù)不足使它們無效。
該公司在檢查期間從設(shè)備管道收集的擦拭樣品，特別是從過XX高效過濾器（HEPA）之后的區(qū)域收集到的樣品中檢測(cè)到多種先前生產(chǎn)的藥物殘留和數(shù)量過多而無法計(jì)數(shù)（TNTC）微生物污染。
FDA檢查發(fā)現(xiàn)該公司缺乏對(duì)設(shè)備上高效過濾器和設(shè)備艙體之間的管道（類似于包衣機(jī)、沸騰干燥機(jī)的風(fēng)管）的書面清潔程序。FDA認(rèn)為這會(huì)導(dǎo)致氣流經(jīng)過骯臟的表面加劇設(shè)備中正在生產(chǎn)的藥物受到污染。
該公司對(duì)留樣樣品進(jìn)行檢測(cè)，結(jié)果確認(rèn)了存在交叉污染;但是，根據(jù)最大允許殘留（MACO） 計(jì)算結(jié)果和其他檢測(cè)結(jié)果，認(rèn)為藥品安全風(fēng)險(xiǎn)較低。
FDA不接受這種說法，F(xiàn)DA認(rèn)為：交叉污染并不均勻，僅對(duì)有限的留樣樣品進(jìn)行檢測(cè)并不能確保產(chǎn)品無污染。雖然 MACO 在經(jīng)過驗(yàn)證的清潔場(chǎng)景中很有幫助，但它不適用于未執(zhí)行清潔或暴露不一致的情況。此外，MACO 計(jì)算中用于批量大小的分母與（b）（4）料倉大小不一致。認(rèn)為該公司的MACO 限度沒有充分的依據(jù)，且未完全涵蓋藥品的污染風(fēng)險(xiǎn)。
FDA在該公司 AHU 區(qū)域地板上觀察到鳥糞和羽毛。FDA認(rèn)為：AHU 區(qū)域的條件令人擔(dān)憂，即可能影響藥品生產(chǎn)過程中使用的關(guān)鍵生產(chǎn)設(shè)備的送風(fēng)。
該公司解釋鳥類通過 AHU 所在工廠外墻上的許多縫隙進(jìn)入工廠。并使用網(wǎng)來阻止鳥類進(jìn)入工廠。FDA表示不接受：FDA認(rèn)為當(dāng)解決鳥類進(jìn)入問題時(shí)，未能進(jìn)行徹底的根本原因分析或評(píng)估其他地方的類似漏洞。此外，安裝的網(wǎng)的似乎仍然允許較小的動(dòng)物（例如昆蟲）進(jìn)入AHU 區(qū)域。
FDA指出，該公司的HEPA 過濾器完整性和粒子計(jì)數(shù)測(cè)試程序沒有明確定義質(zhì)量部門的角色以在預(yù)防性維護(hù)期間確認(rèn)關(guān)鍵 AHU 組件（例如 （b）（4）管道、（b）（4）HEPA 過濾器和 過濾器）的狀況，包括評(píng)估累積殘留、過濾器完整性和整體潔凈度。缺乏監(jiān)督導(dǎo)致在日常維護(hù)期間對(duì)過濾器更換過程的監(jiān)控不足，從而無法檢測(cè)到潛在的過濾器故障、空氣泄漏以及破損HEPA 過濾器和管道造成的污染風(fēng)險(xiǎn)
對(duì) CGMP 記錄的擔(dān)憂：在檢查過程中，在至少 15 個(gè)塑料垃圾袋中發(fā)現(xiàn)了大量撕裂的 CGMP 記錄，包括分析天平打印輸出和包含生產(chǎn)和測(cè)試數(shù)據(jù)的表格。在檢查期間和后續(xù)通信中，該公司提供了支持文件，聲稱在塑料垃圾袋中觀察到的 CGMP 記錄不會(huì)影響產(chǎn)品質(zhì)量。并表示確定了這些問題的幾個(gè)根本原因，包括良好文件記錄實(shí)踐和數(shù)據(jù)完整性方案不夠明確、SOP 規(guī)定不足，要求在有缺陷或難以辨認(rèn)的打印輸出上附加適當(dāng)?shù)淖⑨尅T工對(duì)現(xiàn)有程序的誤解，以及對(duì)內(nèi)包材的原始數(shù)據(jù)的控制不足。對(duì)此，F(xiàn)DA并不接受。
警告信翻譯如下：
警告信 320-25-48
2月 26， 2025
尊敬的 Prasad 博士：
美國食品藥品監(jiān)督管理局 （FDA） 檢查您的藥品生產(chǎn)設(shè)施，Granules India Limited，F(xiàn)EI 3004097901，位于 Gagillapur 第 160/A、161/E、162 和 174/A 號(hào)調(diào)查 村莊， Dundigal-Gandimaisamma Mandal， Medchal-Malkhajgiri 區(qū)， 特倫甘納邦，2024 年 8 月 26 日至 9 月 6 日。
FDA于 2024 年 8 月 26 日至 9 月6 日檢查了你們的藥品生產(chǎn)設(shè)施 Granules India Limited，F(xiàn)EI 3004097901。
這封警告信總結(jié)了重要的 違反現(xiàn)行良好生產(chǎn)規(guī)范 （CGMP） 法規(guī) 成品藥。參見美國聯(lián)邦法規(guī) （CFR） 第 21 篇，部分 210 和 211（21 CFR 第 210 和 211 部分）。
本警告信總結(jié)了成品藥品違反現(xiàn)CGMP的重大違規(guī)。請(qǐng)參閱21 CFR第 210 和 211 部分。
因?yàn)槟姆椒ā⒃O(shè)施或 制造、加工、包裝或保存的控制不符合 CGMP，您的藥品屬于本節(jié)所指的摻假 《聯(lián)邦食品、藥品和化妝品法案》（FD&C 法案）第 501（a）（2）（B） 條第 21 款 美國法典 351（a）（2）（B）。
由于你們的生產(chǎn)、加工、包裝或保存方法、設(shè)施或控制措施不符合 CGMP，你們的藥品按照FD&C 法 第 501（a）（2）（B）、21 CFR 351（a）（2）（B） 被認(rèn)定為摻假。
我們審查了您的 2024 年 9 月 27 日 詳細(xì)回復(fù)我們的 FDA 483 表格并確認(rèn)收到您的 隨后的通信。
我們?cè)敿?xì)審閱了你們于 2024 年 9月 27 日對(duì) FDA 483 表的回復(fù)，并確認(rèn)收到后續(xù)的信件。
在我們的檢查期間，我們的調(diào)查員 觀察到的具體違規(guī)行為包括但不限于以下內(nèi)容。
在我們的檢查過程中，我們的檢查人員觀察到了具體的違規(guī)行為，包括但不限于以下：
1. Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).
貴公司未能建立并遵循適當(dāng)?shù)脑O(shè)備清潔和維護(hù)書面程序 （21 CFR 211.67（b））。
Our investigators observed significant contamination in multiple(b)(4) ducts of non-dedicated (b)(4) used in the preparation of (b)(4) for finished drug products manufactured at your facility. While filters were installed to prevent contamination, inadequate cleaning and maintenance processes rendered them ineffective. Swab samples collected from the (b)(4) ducts by your firm during the inspection, specifically from areas after the (b)(4)μ high efficiency particulate air (HEPA) filters, detected residues from multiple previously manufactured drug products and too numerous to count (TNTC) microbial contamination. Furthermore, you lacked documented cleaning procedures for the sections of the (b)(4) ducts located between the (b)(4)μ HEPA air filter and the cleaning (b)(4). Air flow over dirty surfaces can facilitate contamination of the drug being processed in (b)(4). Robust design, cleaning, and maintenance of this and other equipment are critical to prevent cross-contamination.
我們的檢查人員在你們用于生產(chǎn)成品藥物的非專用設(shè)備的多個(gè)管道觀察到了嚴(yán)重污染。雖然安裝了過濾器以防止污染，但清潔和維護(hù)不足使它們無效。貴公司在檢查期間從 （b）（4） 管道收集的擦拭樣品，特別是從過XX高效過濾器（HEPA）之后的區(qū)域收集到的樣品中檢測(cè)到多種先前生產(chǎn)的藥物殘留和數(shù)量過多而無法計(jì)數(shù)（TNTC）微生物污染。此外，你們?nèi)狈?duì)位于XX HEPA 高效過濾器和XX潔凈設(shè)備之間的管道部分的書面清潔程序。氣流經(jīng)過骯臟的表面會(huì)加劇（b）（4）中正在生產(chǎn)的藥物受到污染。此設(shè)備和其他設(shè)備的穩(wěn)健設(shè)計(jì)、清潔和維護(hù)對(duì)于防止交叉污染至關(guān)重要。
In your response, you provide an impact assessment, limited reserve sample testing results, and assurance of low microbiological contamination risk. You identify multiple potential root causes of the air handling unit (AHU) contamination and propose corrective actions and preventive actions (CAPAs). Reserve sample results confirmed cross-contamination; however, you deem the risk to drug product safety low based on your retrospective maximum allowable carry-over (MACO) calculations and additional testing results.
在你們的回復(fù)中，你們提供了影響評(píng)估、有限的留樣樣品測(cè)試結(jié)果以及低微生物污染風(fēng)險(xiǎn)的保證。你們可以確定空氣處理機(jī)組（AHU）污染的多個(gè)潛在根本原因，并提出糾正措施和預(yù)防措施（CAPA）。留樣樣品結(jié)果確認(rèn)了存在交叉污染；但是，根據(jù)回顧性最大允許殘留（MACO） 計(jì)算結(jié)果和其他檢測(cè)結(jié)果，你們認(rèn)為藥品安全風(fēng)險(xiǎn)較低。
Your response is inadequate. Cross-contamination is not uniform, and testing of limited reserve samples alone cannot ensure products are contaminant-free. While MACO is helpful in validated cleaning scenarios, it cannot apply where cleaning has not been performed, or exposure is inconsistent. Additionally, the denominators utilized for batch size in your MACO calculations are inconsistent with the size of your(b)(4) bowls. The MACO limits outlined in your response were not adequately justified and fully encompass the contamination risk to drug product. Immediate remediation, effective cleaning protocols, and comprehensive testing are essential to resolve this serious CGMP violation.
你們的回復(fù)是不充分的。交叉污染并不均勻，僅對(duì)有限的留樣樣品進(jìn)行檢測(cè)并不能確保產(chǎn)品無污染。雖然 MACO 在經(jīng)過驗(yàn)證的清潔場(chǎng)景中很有幫助，但它不適用于未執(zhí)行清潔或暴露不一致的情況。此外，MACO 計(jì)算中用于批量大小的分母與（b）（4）料倉大小不一致。你們的回復(fù)中概述的 MACO 限度沒有充分的依據(jù)，且未完全涵蓋藥品的污染風(fēng)險(xiǎn)。立即補(bǔ)救、有效的清潔方案和全面的測(cè)試對(duì)于解決這種嚴(yán)重的CGMP 違規(guī)行為至關(guān)重要。
In response to this letter, provide:
回復(fù)此函，請(qǐng)?zhí)峁?/span>
A comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards. Include the identity of residues, other manufacturing equipment that may have been improperly cleaned, and an assessment whether cross-contaminated products may have been released for distribution. The assessment should identify any inadequacies of cleaning procedures and practices, and encompass each piece of manufacturing equipment used to manufacture more than one product.
對(duì)清潔效果進(jìn)行全面、獨(dú)立的回顧性評(píng)估，以評(píng)估交叉污染危害的范圍。包括殘留物的鑒定、可能清潔不當(dāng)?shù)钠渌圃煸O(shè)備，以及評(píng)估是否可能已放行了存在交叉污染的產(chǎn)品。評(píng)估應(yīng)確定清潔程序和實(shí)踐的任何不足之處，并涵蓋用于生產(chǎn)多個(gè)產(chǎn)品的每臺(tái)生產(chǎn)設(shè)備。
A CAPA plan based on the retrospective assessment of your cleaning program, that includes appropriate remediations to your cleaning processes and practices, and timelines for completion. Provide a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning. Describe improvements to your cleaning program, including enhancements to cleaning effectiveness; improved ongoing verification of proper cleaning execution for all products and equipment; and all other needed remediations.
CAPA 計(jì)劃以對(duì)清潔計(jì)劃進(jìn)行回顧性評(píng)估，包括對(duì)清潔流程和實(shí)踐的適當(dāng)補(bǔ)救措施，以及完成時(shí)間表。提供設(shè)備清潔生命周期管理流程中漏洞的詳細(xì)摘要。描述清潔計(jì)劃的改進(jìn)，包括提高清潔效果;改進(jìn)對(duì)所有產(chǎn)品和設(shè)備正確清潔執(zhí)行的持續(xù)確認(rèn);以及所有其他需要的補(bǔ)救措施。
Appropriate improvements to your cleaning validation program, with special emphasis on incorporating conditions identified as worst case in your drug manufacturing operation. This should include but not be limited to identification and evaluation of all worst-case:
適當(dāng)改進(jìn)你們的清潔驗(yàn)證計(jì)劃，特別是納入藥物生產(chǎn)操作中的最差情況。這應(yīng)包括但不限于識(shí)別和評(píng)估所有最差情況：
Drugs with higher toxicities
毒性較高的藥物
Drugs with higher drug potencies
藥物效力較高的藥物
Drugs of lower solubility in their cleaning solvents
在清洗溶劑中溶解度較低的藥物
Drugs with characteristics that make them difficult to clean
具有難以清潔的特性的藥物
Swabbing locations for areas that are most difficult to clean
擦拭最難清潔的區(qū)域
Maximum hold times before cleaning
清潔前的最長保持時(shí)間
In addition, ensure use of appropriate limits that take into account recovery study results and describe the steps that must be taken in your change management system before introduction of new manufacturing equipment or a new product.
此外，請(qǐng)確保使用適當(dāng)?shù)南薅葮?biāo)準(zhǔn)，考慮回收研究結(jié)果，并描述在引入新的生產(chǎn)設(shè)備或新產(chǎn)品之前必須在變更管理系統(tǒng)中采取的步驟。
A summary of updated standard operating procedures (SOPs) that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.
更新的標(biāo)準(zhǔn)作程序（SOP）摘要，確保制定適當(dāng)?shù)挠?jì)劃來驗(yàn)證和確認(rèn)產(chǎn)品、工藝和設(shè)備的清潔程序。
A holistic review of cleaning procedures and the associated cleaning validation strategy for all manufacturing equipment to determine whether similar deficiencies exist.
對(duì)所有生產(chǎn)設(shè)備的清潔程序和相關(guān)的清潔驗(yàn)證策略進(jìn)行全面審查，以確定是否存在類似的缺陷。
2. Your firm failed to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair (21 CFR 211.58).
貴公司未能將用于生產(chǎn)、加工、包裝或儲(chǔ)存藥品的建筑保持良好的維護(hù)狀態(tài) （21 CFR 211.58）。
Bird droppings and feathers were observed during the inspection in the AHU area, specifically on the air purification units,(b)(4) ducts, a (b)(4) tank, a cleaning (b)(4), and on the floors surrounding multiple (b)(4) inside your drug manufacturing facility. The conditions in your AHU area raise concerns about potential contamination affecting the air supplied to critical manufacturing equipment utilized in your drug manufacturing process.
在 AHU 區(qū)域進(jìn)行檢查期間，特別是在空氣凈化裝置、（b）（4） 管道、（b）（4） 水箱、清潔 （b）（4） 以及藥品生產(chǎn)設(shè)施內(nèi)多個(gè) （b）（4） 周圍的地板上觀察到鳥糞和羽毛。AHU 區(qū)域的條件令人擔(dān)憂，即可能影響藥品生產(chǎn)過程中使用的關(guān)鍵生產(chǎn)設(shè)備的送風(fēng)。
In your response, you explain that birds were entering the manufacturing facility through numerous gaps in the exterior walls of the facility where the AHUs are located. You outline immediate actions to identify and block entry points for birds using nets.
在你們的回復(fù)中，你們解釋說，鳥類通過 AHU 所在工廠外墻上的許多縫隙進(jìn)入工廠。你們概述了使用鳥網(wǎng)識(shí)別和阻止鳥類進(jìn)入點(diǎn)的即時(shí)行動(dòng)。
Your response is inadequate. While you address the entry of birds and cleaned the area, you fail to perform a thorough root cause analysis or assess similar vulnerabilities elsewhere. Furthermore, pictures of the netting you installed appear to still allow smaller animals, such as insects, access to your AHU area.
你們的回復(fù)是不充分的。當(dāng)解決鳥類進(jìn)入問題并清理該區(qū)域時(shí)，你們未能進(jìn)行徹底的根本原因分析或評(píng)估其他地方的類似漏洞。此外，你們安裝的網(wǎng)的照片似乎仍然允許較小的動(dòng)物（例如昆蟲）進(jìn)入你們的AHU 區(qū)域。
In response to this letter provide a CAPA plan and timeline to implement routine, vigilant operations management oversight of facilities. This plan should ensure, among other things, prompt detection of facilities contamination issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the facility infrastructure, and improved systems for ongoing management review.
回復(fù)此函，請(qǐng)?zhí)峁?CAPA 計(jì)劃和時(shí)間表，以對(duì)設(shè)施實(shí)施例行、警惕的運(yùn)營管理監(jiān)督。除其他外，該計(jì)劃應(yīng)確保及時(shí)發(fā)現(xiàn)設(shè)施污染問題、有效執(zhí)行維修、遵循適當(dāng)?shù)念A(yù)防性維護(hù)計(jì)劃、及時(shí)對(duì)設(shè)施基礎(chǔ)設(shè)施進(jìn)行技術(shù)升級(jí)，以及改進(jìn)系統(tǒng)以進(jìn)行持續(xù)的管理審查。
3. Your firm failed to routinely calibrate, inspect, or check according to a written program designed to assure proper performance of automatic, mechanical, electronic equipment, or other types of equipment, including computers, used in the manufacture, processing, packing, and holding of a drug product (21 CFR 211.68(a)).
貴公司未能按照書面程序進(jìn)行日常校準(zhǔn)、檢查或檢定，以確保用于生產(chǎn)、加工、包裝和保存藥品的自動(dòng)、機(jī)械、電子設(shè)備或其他類型設(shè)備（包括計(jì)算機(jī)）正常運(yùn)行 （21 CFR 211.68（a））。
You failed to adequately inspect and maintain your AHUs to ensure air filters would be effective at preventing contamination. The procedure for HEPA filter integrity and particle count testing did not clearly define the quality unit’s role in verifying the condition of critical AHU components, such as(b)(4) ducts, (b)(4)μ HEPA filters, and (b)(4)μ filters, during preventive maintenance, including assessing accumulated residues, filter integrity, and overall cleanliness. The lack of oversight led to insufficient monitoring of the filter replacement process during routine maintenance, preventing the detection of potential filter failures, air leakage, and contamination risks from compromised HEPA filters and ducting, which remained unaddressed and uninvestigated. These deficiencies demonstrate your failure to maintain a robust program to assure the proper performance of equipment essential to the manufacturing, processing, and holding of your drug products.
你們未能充分檢查和維護(hù) AHU 以確保空氣過濾器能夠有效防止污染。HEPA 過濾器完整性和粒子計(jì)數(shù)測(cè)試程序沒有明確定義質(zhì)量部門的角色以在預(yù)防性維護(hù)期間確認(rèn)關(guān)鍵 AHU 組件（例如 （b）（4）管道、（b）（4）HEPA 過濾器和 過濾器）的狀況，包括評(píng)估累積殘留、過濾器完整性和整體潔凈度。缺乏監(jiān)督導(dǎo)致在日常維護(hù)期間對(duì)過濾器更換過程的監(jiān)控不足，從而無法檢測(cè)到潛在的過濾器故障、空氣泄漏以及破損HEPA 過濾器和管道造成的污染風(fēng)險(xiǎn)，這些問題仍未得到解決和調(diào)查。這些缺陷表明你們未能維持一個(gè)強(qiáng)大的計(jì)劃，以確保對(duì)藥品的生產(chǎn)、加工和保存至關(guān)重要的設(shè)備正常運(yùn)行。
In your response, you note damage to the(b)(4) filters was confirmed by the original equipment manufacturer and potentially increased pressure differentials. You propose monitoring pressure differentials to determine when cleaning or replacement of filters is needed.
在你們的回復(fù)中，你們指出原設(shè)備制造商已確認(rèn) （b）（4） 過濾器損壞，并且壓差可能增加。你們建議監(jiān)測(cè)壓差，以確定何時(shí)需要清潔或更換過濾器。
Your response is inadequate. While you acknowledge damage to the(b)(4) and propose periodic pressure differential monitoring, you fail to address the root cause or assess risks to airflow and cross-contamination identified during this inspection.
你們的回復(fù)是不充分的。雖然你們承認(rèn)（b）（4）的損壞并提議定期進(jìn)行壓差監(jiān)測(cè)，但你們未能解決根本原因或評(píng)估本次檢查期間發(fā)現(xiàn)的氣流和交叉污染風(fēng)險(xiǎn)。
In response to this letter, provide your CAPA plan to implement routine, vigilant operations management oversight of equipment. This plan should ensure, among other things, prompt detection of equipment performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment infrastructure, and improved systems for ongoing management review. Your plan should also ensure that appropriate actions are taken throughout the company network.
回復(fù)此函，請(qǐng)?zhí)峁┠銈兊?CAPA 計(jì)劃，以對(duì)設(shè)備實(shí)施日常、警惕的運(yùn)營管理監(jiān)督。除其他外，該計(jì)劃應(yīng)確保及時(shí)發(fā)現(xiàn)設(shè)備性能問題、有效執(zhí)行維修、遵循適當(dāng)?shù)念A(yù)防性維護(hù)計(jì)劃、及時(shí)對(duì)設(shè)備基礎(chǔ)設(shè)施進(jìn)行技術(shù)升級(jí)，以及改進(jìn)系統(tǒng)以進(jìn)行持續(xù)的管理審查。你們的計(jì)劃還應(yīng)確保在整個(gè)公司網(wǎng)絡(luò)中采取適當(dāng)?shù)男袆?dòng)。
Concerns with CGMP records
對(duì) CGMP 記錄的擔(dān)憂
A large amount of torn CGMP records were discovered in at least 15 plastic waste bags during the inspection, including analytical balance printouts and worksheets containing manufacturing and testing data.
在檢查過程中，在至少 15 個(gè)塑料垃圾袋中發(fā)現(xiàn)了大量撕裂的 CGMP 記錄，包括分析天平打印輸出和包含生產(chǎn)和測(cè)試數(shù)據(jù)的表格。
檢查期間和后續(xù) 通信中，您提供了支持文件，聲稱 CGMP 在塑料垃圾袋中觀察到的記錄不會(huì)影響產(chǎn)品質(zhì)量。你 確定了這些問題的幾個(gè)根本原因，包括清晰度不足 在良好的文檔實(shí)踐和數(shù)據(jù)完整性協(xié)議中，SOP 不足 要求附加有缺陷或難以辨認(rèn)的打印輸出 適當(dāng)?shù)淖⑨尅T工對(duì)現(xiàn)有程序的誤解，以及 對(duì)初級(jí)包裝材料的原始數(shù)據(jù)表控制不足。
在檢查期間和后續(xù)通信中，你們提供了支持文件，聲稱在塑料垃圾袋中觀察到的 CGMP 記錄不會(huì)影響產(chǎn)品質(zhì)量。你們確定了這些問題的幾個(gè)根本原因，包括良好文件記錄實(shí)踐和數(shù)據(jù)完整性方案不夠明確、SOP 規(guī)定不足，要求在有缺陷或難以辨認(rèn)的打印輸出上附加適當(dāng)?shù)淖⑨尅T工對(duì)現(xiàn)有程序的誤解，以及對(duì)內(nèi)包材的原始數(shù)據(jù)的控制不足。
您的質(zhì)量體系不充分 確保數(shù)據(jù)的準(zhǔn)確性和完整性，以支持安全性、有效性、 以及您生產(chǎn)的藥物的質(zhì)量。請(qǐng)參閱 FDA 的指導(dǎo)文件數(shù)據(jù) 藥品 CGMP 的完整性和合規(guī)性，為建立提供指導(dǎo) 以及遵循 https://www.fda.gov/media/119267/download 符合 CGMP 的數(shù)據(jù)完整性實(shí)踐。
你們的質(zhì)量體系無法充分確保數(shù)據(jù)的準(zhǔn)確性和完整性，以支持所生產(chǎn)的藥物的安全性、有效性和質(zhì)量。請(qǐng)參閱 FDA 指南《藥物 CGMP 的數(shù)據(jù)完整性和合規(guī)性》了解有關(guān)建立和遵循 CGMP 合規(guī)數(shù)據(jù)可靠性實(shí)踐的指南：https://www.fda.gov/media/119267/download。
來源：Internet
