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嘉峪檢測網(wǎng) 2025-03-11 20:44
Regulatory compliance in the pharmaceutical and medical-device sectors is paramount for protecting public health. In the United States, the Food and Drug Administration (FDA) enforces laws and regulations to ensure that products meet stringent safety and efficacy standards. To achieve that goal, the FDA conducts inspection of manufacturing and distribution facilities. Authority for such activities derives from the Federal Food, Drug, and Cosmetic (FD&C) Act, particularly section 704, which grants the FDA broad powers to inspect facilities, records, and products.
制藥和醫(yī)療器械行業(yè)的法規(guī)符合性對于保護(hù)公眾健康至關(guān)重要。在美國，F(xiàn)DA執(zhí)行法律和法規(guī)以確保產(chǎn)品符合嚴(yán)格的安全性和有效性標(biāo)準(zhǔn)。為了實(shí)現(xiàn)這一目標(biāo)，F(xiàn)DA 對制造和分銷設(shè)施進(jìn)行檢查。此類活動的授權(quán)來自FD&C法案，特別是第704 節(jié)，該法案授予 FDA 檢查設(shè)施、記錄和產(chǎn)品的廣泛權(quán)力。
The FDA’s guidance documentCircumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection outlines the behaviors and actions that can be deemed noncompliant during such inspections (1). The guidance clarifies what constitutes as obstruction of an inspection, helping manufacturers to avoid legal and regulatory repercussions. The document covers a breadth of scenarios, from preannounced inspections to refusals to permit entry, providing a clear framework for understanding FDA expectations.
FDA 的指導(dǎo)文件《構(gòu)成延遲、阻礙、限制或拒絕藥品或器械檢查的情況》概述了在此類檢查期間可能被視為不合規(guī)的行為和行動（1）。該指南闡明了什么構(gòu)成阻礙檢查，幫助制造商避免法律和監(jiān)管影響。該文件涵蓋了從預(yù)先宣布的檢查到拒絕允許進(jìn)入的廣泛場景，為理解FDA 的期望提供了一個清晰的框架。
Key Areas of Concern
主要關(guān)注領(lǐng)域
The FDA guidance document identifies several key areas in which facilities must exercise caution to maintain compliance. Such areas include delaying, denying, limiting, or refusing an inspection. Each action can have significant implications for a facility, potentially leading to severe penalties, including the classification of products as adulterated.
FDA 指南文件確定了工廠必須謹(jǐn)慎行事以保持合規(guī)性的幾個關(guān)鍵領(lǐng)域。這些領(lǐng)域包括延遲、阻礙、限制或拒絕檢查。每項(xiàng)作都可能對工廠產(chǎn)生重大影響，可能導(dǎo)致嚴(yán)厲的處罰，包括將產(chǎn)品歸類為摻假。
Delay of Inspections:Preapproval and prelicense inspections tend to be preannounced, as are inspections for foreign facilities. Although the FD&C Act does not mandate preannouncements, they are a common practice to facilitate the inspection process. The FDA usually contacts a facility beforehand to ensure the availability of relevant records and personnel. However, delays in scheduling such inspections can constitute noncompliance, especially if a facility’s management fails to agree on a start date without reasonable explanation.
檢查延遲：批準(zhǔn)前和許可證前檢查往往是預(yù)先通知的，對國外設(shè)施的檢查也是如此。雖然FD&C 法案沒有強(qiáng)制要求預(yù)先通知，但這是促進(jìn)檢查過程的常見做法。FDA通常會事先聯(lián)系工廠，以確保相關(guān)記錄和人員準(zhǔn)備就緒。但是，延遲安排此類檢查可能構(gòu)成不合規(guī)，特別是如果工廠管理層在沒有合理解釋的情況下未能就開始日期達(dá)成一致。
Consider a scenario in which a facility is notified of an upcoming preapproval inspection. The FDA attempts to schedule the inspection, but the facility’s management continually requests postponements without providing valid reasons. Eventually, the facility stops responding to FDA communications. In that case, the facility’s actions could be interpreted as a deliberate attempt to delay the inspection, potentially leading to regulatory action. A reasonable explanation, such as ongoing renovations that render a facility inaccessible or unsafe, would mitigate the situation only if properly communicated and documented.
考慮這樣一種情況：工廠收到即將進(jìn)行的批準(zhǔn)前檢查的通知。FDA 試圖安排檢查，但工廠的管理層不斷要求推遲檢查，而沒有提供正當(dāng)理由。最終，該工廠停止回應(yīng) FDA 的通報。在這種情況下，該設(shè)施的行為可能會被解釋為故意延遲檢查，這可能會導(dǎo)致監(jiān)管行動。合理的解釋，例如正在進(jìn)行的翻修導(dǎo)致設(shè)施無法進(jìn)入或不安全，只有在適當(dāng)溝通和記錄的情況下才能緩解這種情況。
Delay During an Inspection:FDA investigators are authorized to inspect all areas of a facility that bear on whether drugs or devices are adulterated, misbranded, or otherwise in violation of the FD&C Act. Delays during an inspection can arise from restricted access to operational areas, unavailability of necessary personnel, or delays in providing documentation. Such actions can hinder the inspection process significantly.
檢查期間的延誤：FDA 檢查人員有權(quán)檢查設(shè)施中所有與藥品或器械是否摻假、貼錯標(biāo)簽或其他違反 FD&C 法案有關(guān)要求。檢查期間的延誤可能是：進(jìn)入操作區(qū)域受限、缺乏必要人員或延遲提供文件。此類操作會嚴(yán)重阻礙檢查過程。
During an unannounced inspection, for example, an FDA investigator requests access to a facility’s sterile manufacturing area. The facility’s management, however, insists that the investigator wait several hours before entering, citing ongoing cleaning. Upon investigation, it is revealed that no such cleaning was scheduled, and the delay was an attempt to prevent the investigator from observing specific production activities. Such behavior would be deemed noncompliant because it obstructs the investigator’s ability to conduct a thorough inspection.
例如，在突擊檢查期間，F(xiàn)DA 檢查人員要求進(jìn)入工廠的無菌生產(chǎn)區(qū)域。然而，該設(shè)施的管理層堅(jiān)持要求檢查人員等待幾個小時才能進(jìn)入，理由是正在進(jìn)行清潔。經(jīng)調(diào)查，發(fā)現(xiàn)沒有安排此類清潔，此延遲是為了阻止檢查人員觀察特定的生產(chǎn)活動。這種行為將被視為不合規(guī)，因?yàn)樗璧K了檢查人員進(jìn)行徹底檢查的能力。
Delay in Producing Records:Facilities must be prepared to provide all requested documentation in a timely manner. Delays in producing records, especially without a reasonable explanation, can be considered an attempt to obstruct the inspection. The FDA’s authority extends to both hardcopy and electronic records, and facilities must ensure that such documents are readily accessible.
延遲提供記錄： 工廠必須準(zhǔn)備好及時提供所有要求的文件。延遲提供記錄，尤其是沒有合理解釋，可被視為試圖阻礙檢查。FDA 的權(quán)力涵蓋硬拷貝和電子記錄，設(shè)施必須確保此類文件易于訪問。
Consider a facility that maintains its financial and production records at an offsite location. During an inspection, the FDA requests specific records, but the facility’s management states that accessing those records will take several days. Such a delay, if not adequately justified, could be considered an obstruction. However, if the facility provides a clear explanation (such as the need to retrieve records from a remote archive) and works to minimize the delay, then it can avoid noncompliance issues.
試想一下：一個在異地位置維護(hù)其財務(wù)和生產(chǎn)記錄的設(shè)施。在檢查期間，F(xiàn)DA 要求提供特定記錄，但該設(shè)施的管理層表示，訪問這些記錄需要幾天時間。這種延誤，如果沒有充分的理由，可被視為一種阻礙。但是，如果工廠提供明確的解釋（例如需要從遠(yuǎn)程存檔中檢索記錄）并努力最大限度地減少延遲，那么它可以避免不合規(guī)問題。
Denial of Inspection:The FDA’s guidance interprets denial broadly, including behavior that prevents an FDA representative from conducting or completing an inspection. This encompasses both active refusals and passive actions that obstruct inspections. Denial can include outright refusals to schedule or allow inspections, as well as misleading or deceptive actions that hinder the inspection process.
拒絕檢查：FDA 的指南對拒絕檢查進(jìn)行了廣泛的解釋，包括阻止FDA 人員進(jìn)行或完成檢查的行為。這包括主動拒絕和阻礙檢查的被動行動。拒絕包括公然拒絕安排或拒絕允許檢查，以及阻礙檢查過程的誤導(dǎo)性或欺騙性行為。
For example, facility management falsely claims that it has ceased all manufacturing operations when FDA investigators arrive for an unannounced inspection. Representatives state that the site is undergoing renovations, and no products are being produced. However, subsequent evidence reveals that the facility had active production lines and was attempting to avoid inspection. Such behavior constitutes a clear denial of inspection because it involves intentionally misleading investigators.
例如，當(dāng) FDA 檢查人員到達(dá)現(xiàn)場進(jìn)行突擊檢查時，管理部門錯誤地聲稱已停止所有生產(chǎn)業(yè)務(wù)。表示：該場地正在進(jìn)行翻新，沒有生產(chǎn)任何產(chǎn)品。然而，隨后的證據(jù)表明，該工廠的生產(chǎn)線正在運(yùn)行，并試圖逃避檢查。這種行為明顯構(gòu)成拒絕檢查，因?yàn)樗婕肮室庹`導(dǎo)檢查人員。
Limiting Inspection: Limiting an inspection involves restricting its scope or extent, such as blocking access to certain areas, restricting observation of specific processes, or withholding information. The FDA considers such actions to be potentially obstructive because they prevent comprehensive evaluation of the facility’s compliance with regulatory standards. Facilities must provide FDA investigators with reasonable access to all areas and processes relevant to the inspection. Limiting access without a valid reason can be interpreted as an attempt to conceal noncompliance. For example, ceasing production during an inspection without reasonable explanation can hinder the FDA’s ability to observe standard operating procedures (SOPs) and manufacturing practices in action.
限制檢查：限制檢查涉及限制其范圍或程度，例如阻止訪問某些區(qū)域、限制對特定過程的觀察或隱瞞信息。FDA 認(rèn)為此類行動具有潛在的阻礙性，因?yàn)樗鼈儠柚箤S是否符合監(jiān)管標(biāo)準(zhǔn)進(jìn)行全面評估。企業(yè)必須為 FDA 檢查人員提供與檢查相關(guān)的所有區(qū)域和工藝的合理訪問權(quán)限。在沒有正當(dāng)理由的情況下限制訪問可以解釋為試圖掩蓋不合規(guī)行為。例如，在檢查期間在沒有合理解釋的情況下停止生產(chǎn)可能會阻礙 FDA 觀察標(biāo)準(zhǔn)作程序（SOP）和生產(chǎn)實(shí)踐的能力。
Imagine that an FDA inspection team arrives at a facility to conduct a routine inspection. Upon arrival, the team is informed that all production activities have been halted temporarily for maintenance reasons. However, there is no evidence of maintenance work being conducted, and the shutdown appears to have been orchestrated to prevent the inspection team from observing certain processes. Such actions are likely to be viewed as limiting inspection, potentially leading to regulatory action.
想象一下，一個 FDA 檢查組到達(dá)工廠進(jìn)行例行檢查。到達(dá)后，團(tuán)隊(duì)被告知，由于維護(hù)原因，所有生產(chǎn)活動都已暫時停止。然而，沒有證據(jù)表明正在進(jìn)行維護(hù)工作，而且關(guān)閉似乎是經(jīng)過精心策劃的，以防止檢查小組觀察某些過程。此類行動可能被視為限制檢查，并可能導(dǎo)致監(jiān)管行動。
Limiting Photography: Photography during inspections serves as an objective method of documenting facility conditions. The FDA uses photographs to record evidence of compliance or noncompliance, such as the presence of contaminants, inadequate storage conditions, or improper labeling. Limiting the use of photography without legitimate reason can be seen as an attempt to obstruct the inspection.
限制拍照：檢查期間的拍照是記錄設(shè)施狀況的客觀方法。FDA 使用照片來記錄合規(guī)或不合規(guī)的證據(jù)，例如存在污染物、儲存條件不足或標(biāo)簽不當(dāng)。在沒有正當(dāng)理由的情況下限制使用拍照可被視為企圖阻礙檢查。
During an inspection, for example, an FDA investigator attempts to photograph a specific area where raw materials are stored. The facility’s management objects, citing concerns about protecting trade secrets and proprietary processes. Although protecting sensitive information is a valid concern, it must be balanced against the need for transparency. The manufacturer should provide a reasonable explanation and offer alternate methods to document conditions without compromising proprietary information.
例如，在檢查期間，F(xiàn)DA 檢查人員試圖拍攝儲存原輔料的特定區(qū)域。該設(shè)施的管理層以對保護(hù)商業(yè)秘密和專有工藝的擔(dān)憂為由提出反對意見。盡管保護(hù)敏感信息是一個合理的擔(dān)憂，但它必須與透明度的需求相平衡。制造商應(yīng)提供合理的解釋，并提供其他不會影響專有信息的方法來記錄情況。
Limiting Access to Records:The FDA’s ability to review and copy records is a critical component of its inspection process. Limiting access to records, redacting essential information, or providing incomplete documentation can hinder assessment. Facilities must ensure that all relevant records — including electronic data — are available and accessible to facilitate thorough inspection.
限制對記錄的訪問：FDA 審查和復(fù)制記錄的權(quán)利是其檢查過程的關(guān)鍵組成部分。限制對記錄的訪問、篡改重要信息或提供不完整的文件可能會阻礙檢查。企業(yè)必須確保所有相關(guān)記錄（包括電子數(shù)據(jù)）都可用且可訪問，以便于徹底檢查。
For instance, an FDA investigator might request access to production records, including batch records and quality-control (QC) data. The facility provides some documents but withholds others, claiming that they are not relevant to the inspection. However, upon review, it becomes evident that the withheld records contain critical information about product quality and safety. Such selective disclosure can be considered an attempt to limit inspection, potentially leading to significant regulatory consequences.
例如，F(xiàn)DA 檢查人員可能會請求訪問生產(chǎn)記錄，包括批記錄和質(zhì)量控制 （QC） 數(shù)據(jù)。該設(shè)施提供了一些文件，但扣留了另外一些文件，聲稱這些文件與檢查無關(guān)。但是，經(jīng)過審核，很明顯，被扣留的記錄包含有關(guān)產(chǎn)品質(zhì)量和安全的關(guān)鍵信息。這種選擇性披露可被視為試圖限制檢查，可能導(dǎo)致重大的監(jiān)管后果。
Limiting or Preventing Sample Collection: An integral part of FDA inspections, sample collection enables laboratory analysis and compliance verification. Preventing or limiting collection can disrupt an inspection and raise concerns about product integrity.
限制或阻止樣品采集：樣品采集是 FDA 檢查的一個組成部分，可用于實(shí)驗(yàn)室分析和合規(guī)性驗(yàn)證。阻止或限制收集可能會干擾檢驗(yàn)并引起對產(chǎn)品完整性的擔(dān)憂。
During an inspection, for example, FDA investigators request samples of a recently manufactured batch of drug product (DP). The facility’s management refuses, citing that the samples are reserved for internal testing and cannot be released. The refusal to provide samples without a valid reason can be seen as an attempt to prevent the agency from conducting a thorough analysis. Facilities must ensure that all sample requests are met to verify product compliance.
例如，在檢查期間，F(xiàn)DA 檢查人員要求提供最近生產(chǎn)的藥品批次的樣品。該工廠的管理層拒絕，理由是這些樣品是留作內(nèi)部檢測的，不能放行。在沒有正當(dāng)理由的情況下拒絕提供樣品可以被視為試圖阻止FDA進(jìn)行徹底分析。工廠必須確保滿足所有樣品請求，以驗(yàn)證產(chǎn)品合規(guī)性。
Refusal to permit entry or inspection encompasses both active and passive behaviors that prevent FDA investigators from accessing a facility. This includes not unlocking doors, ignoring FDA communications, or otherwise making it difficult for investigators to conduct their work. Such actions can lead to severe regulatory consequences, including the classification of products as adulterated.
拒絕允許進(jìn)入或檢查：包括主動和被動阻止 FDA 檢查人員進(jìn)入設(shè)施的行為。這包括鎖門、無視 FDA 的溝通或以其他方式使檢查人員難以開展工作。此類行為可能導(dǎo)致嚴(yán)重的監(jiān)管后果，包括將產(chǎn)品歸類為摻假商品。
Imagine that an FDA inspection team attempts to schedule an inspection with a facility but receives no response despite multiple attempts. When the team arrive at the facility, they find it locked with no staff available to grant entry. The lack of communication and refusal to permit entry can be considered an obstruction of the inspection process. The facility must ensure that appropriate personnel are available to facilitate the inspection and provide necessary access. Acceptable reasons for postponing FDA inspections include emergencies and natural disasters, renovations and other planned shutdowns, cybersecurity incidents, and absence of key personnel.
想象一下，F(xiàn)DA 檢查組試圖安排與工廠進(jìn)行檢查，但盡管多次嘗試仍未收到任何回復(fù)。當(dāng)團(tuán)隊(duì)到達(dá)工廠時，他們發(fā)現(xiàn)設(shè)施上鎖著，沒有工作人員可以允許進(jìn)入。缺乏溝通和拒絕允許進(jìn)入可被視為對檢查過程的阻礙。設(shè)施必須確保有適當(dāng)?shù)娜藛T來協(xié)助檢查并提供必要的通道。推遲FDA 檢查的可接受原因包括緊急情況和自然災(zāi)害、裝修和其他計劃性關(guān)閉、網(wǎng)絡(luò)安全事件以及關(guān)鍵人員不可用。
Natural Disasters or Emergency Situations:During events such as the COVID-19 pandemic, companies faced significant disruptions that affected their ability to comply with inspection schedules. Natural disasters (e.g., hurricanes, floods, and earthquakes) also can render facilities temporarily inoperable or unsafe, justifying a request for inspection postponement.
自然災(zāi)害或緊急情況： 在大流行等事件期間，公司面臨重大中斷，影響了他們遵守檢查計劃的能力。自然災(zāi)害（例如颶風(fēng)、洪水和地震）也可能導(dǎo)致設(shè)施暫時無法運(yùn)行或不安全，因此有理由要求推遲檢查。
Planned Shutdowns or Renovations:If a company already has scheduled a shutdown for maintenance or renovations, and the FDA proposes an inspection date during that period, then the shutdown could be a legitimate reason to request a delay. The FDA itself acknowledges that such planned events, which temporarily disrupt normal operations, may not be considered inspection delays.
計劃性停工或翻新：如果一家公司已經(jīng)安排停工進(jìn)行維護(hù)或翻新，然后 FDA 建議在此期間進(jìn)行檢查，那么停工可能是要求延遲的合法理由。FDA 本身承認(rèn)，此類暫時擾亂正常運(yùn)營的計劃事件可能不被視為檢查延誤。
Cybersecurity Incidents:In rare cases, companies can experience cybersecurity incidents that compromise their operational capabilities. For example, consider a company that experienced a significant cyberattack, leading to postponement of an FDA inspection by about a month. Although such situations typically are not publicized, they provide valid ground for requesting delays, especially when incidents affect access to critical systems or data.
網(wǎng)絡(luò)安全事件：在極少數(shù)情況下，公司可能會遇到損害其運(yùn)營能力的網(wǎng)絡(luò)安全事件。例如，考慮一家公司遭受了一次重大網(wǎng)絡(luò)攻擊，導(dǎo)致FDA 檢查推遲了大約一個月。盡管此類情況通常不會公開，但它們?yōu)檎埱笱舆t提供了正當(dāng)理由，尤其是當(dāng)事件影響對關(guān)鍵系統(tǒng)或數(shù)據(jù)的訪問時。
Key Personnel Unavailability:Key staff members, such as those responsible for compliance or production, may become unexpectedly unavailable (e.g., due to illness or urgent personal matters). That could justify a request to postpone inspection. FDA guidance suggests that unavailability of essential personnel can be a reasonable explanation, especially if their presence is critical to inspection.
關(guān)鍵人員不可用： 關(guān)鍵員工（例如負(fù)責(zé)合規(guī)或生產(chǎn)的人員）可能會意外不可用（例如，由于疾病或緊急個人事務(wù)）。這可能證明推遲檢查的請求是合理的。FDA 指南表明，沒有必要人員可能是一個合理的解釋，特別是如果他們的存在對檢查至關(guān)重要。
Practical Implications and Best Practices
實(shí)際意義和最佳實(shí)踐
Understanding and adhering to FDA guidelines during inspections is crucial for maintaining compliance and avoiding severe penalties. Facilities must implement best practices to ensure that they are prepared for inspections and can respond appropriately to FDA requests. Below are some practical steps that facilities can take to maintain compliance during inspections.
在檢查過程中了解并遵守 FDA指南對于保持合規(guī)性和避免嚴(yán)厲處罰至關(guān)重要。企業(yè)必須實(shí)施最佳實(shí)踐，以確保他們?yōu)闄z查做好準(zhǔn)備，并能夠適當(dāng)?shù)仨憫?yīng) FDA的要求。以下是工廠可以采取的一些實(shí)際步驟，以便在檢查期間保持合規(guī)性。
Preinspection Preparation: Facilities should conduct regular training sessions for staff members to ensure that they are aware of the FDA’s inspection process and the facility’s compliance obligations. That includes training on proper documentation, record-keeping practices, and communication protocols during inspections.
檢查前準(zhǔn)備：企業(yè)應(yīng)定期為員工舉辦培訓(xùn)課程，以確保他們了解 FDA 的檢查流程和企業(yè)的合規(guī)義務(wù)。這包括檢查期間有關(guān)正確文件、記錄保存實(shí)踐和溝通方案的培訓(xùn)。
Maintaining accurate and up-to-date recordsis critical for demonstrating compliance. Facilities should establish robust record-keeping systems that provide easy retrieval of documents during inspections. This includes electronic record systems that are secure, reliable, and accessible to authorized personnel.
維護(hù)準(zhǔn)確和最新的記錄對于證明合規(guī)性至關(guān)重要。工廠應(yīng)建立強(qiáng)大的記錄保存系統(tǒng)，以便在檢查期間輕松檢索文件。這包括安全、可靠且可供授權(quán)人員訪問的電子記錄系統(tǒng)。
Facilities should conductregular internal audits to assess their compliance status and identify potential areas of concern. These audits can help facilities prepare for inspections by ensuring that all areas comply with FDA regulations and that all necessary documentation is readily available.
工廠應(yīng)定期進(jìn)行內(nèi)部審計，以評估其合規(guī)性狀態(tài)并確定潛在的關(guān)注領(lǐng)域。這些審核可以通過確保所有區(qū)域都符合FDA 法規(guī)并且所有必要的文件都隨時可用，幫助工廠為檢查做好準(zhǔn)備。
Facilities must provide FDA investigators withunrestricted access to all areas and processes relevant to the inspection. That also includes access to secure areas such as cleanrooms or sterile processing zones, following appropriate gowning and safety procedures.
企業(yè)必須允許 FDA 檢查人員不受限制地進(jìn)入與檢查相關(guān)的所有區(qū)域和流程。這還包括進(jìn)入安全區(qū)域，如潔凈室或無菌加工區(qū)，遵循適當(dāng)?shù)母潞桶踩绦颉?/span>
Transparencyis key during inspections. Facilities should provide complete, accurate information to FDA investigators and prevent any actions that could be perceived as obstructive. Delays and restrictions must have clear explanations, and information and sample requests still must be met.
透明度是檢查過程中的關(guān)鍵。企業(yè)應(yīng)向 FDA 人員提供完整、準(zhǔn)確的信息，并防止采取任何可能被視為阻礙的行動。延誤和限制必須有明確的原因，并且仍然必須滿足信息和樣品請求。
Establishingclear communication protocols can help to facilitate a smooth inspection. That includes designating a point of contact for an inspection team and ensuring that all relevant personnel are available to address questions or concerns raised by investigators.
建立明確的溝通方案有助于促進(jìn)順利檢查。這包括為檢查組指定一個聯(lián)絡(luò)點(diǎn)，并確保所有相關(guān)人員都可以解決調(diào)檢查員提出的問題或疑慮。
Postinspection Follow-Up: Following an inspection, facilities should review the FDA’s findings and take immediate action to address any identified issues. That can include implementing corrective and preventive actions (CAPAs) to address noncompliance and mitigate future occurrences.
檢查后跟進(jìn)：檢查后，企業(yè)應(yīng)審查 FDA 的檢查結(jié)果，并立即采取行動解決任何發(fā)現(xiàn)的問題。這可能包括實(shí)施糾正和預(yù)防措施 （CAPA） 來解決不合規(guī)問題并減少未來發(fā)生的情況。
Manufacturers shoulddocument all actions taken in response to inspection findings and report them to the FDA as required. Facilities must provide evidence of corrective actions and demonstrate ongoing compliance with FDA regulations.
制造商應(yīng)記錄為應(yīng)對檢查結(jié)果而采取的所有行動，并根據(jù)需要向 FDA 報告。企業(yè)必須提供糾正措施的證據(jù)，并證明持續(xù)符合 FDA 法規(guī)。
Continuous improvement is essential for maintaining compliance in the ever-evolving regulatory landscape. Manufacturers should review and update their compliance programs frequently to address new regulations and industry best practices, stay informed about changes in FDA guidance, and participate in industry forums and training programs.
持續(xù)改進(jìn)對于在不斷變化的監(jiān)管環(huán)境中保持合規(guī)性至關(guān)重要。制造商應(yīng)經(jīng)常審查和更新其合規(guī)計劃，以應(yīng)對新的法規(guī)和行業(yè)最佳實(shí)踐，隨時了解FDA 指南的變化，并參與行業(yè)論壇和培訓(xùn)計劃。
Continued Compliance
持續(xù)合規(guī)
Compliance with FDA inspection requirements is a critical aspect of ensuring the safety and efficacy of drugs and medical devices. The guidance document reviewed herein provides a framework for understanding the actions that constitute delaying, denying, limiting, or refusing an inspection. Facilities must understand the guidelines and align their practices with regulatory expectations to avoid severe consequences, including product adulteration designations and potential legal actions. To mitigate potential problems with the FDA, manufacturers should focus on maintaining clear, transparent, and proactive communication with the agency. Below are some specific actions that facility management can take to ensure compliance.
遵守 FDA 檢查要求是確保藥品和醫(yī)療器械安全性和有效性的關(guān)鍵方面。本文回顧的指導(dǎo)文件提供了一個框架，用于了解構(gòu)成延遲、拒絕、限制或拒絕檢查的行為。企業(yè)必須了解指南，并將其做法與監(jiān)管要求保持一致，以避免嚴(yán)重后果，包括商品摻假認(rèn)定和潛在的法律訴訟。為了減輕FDA 的潛在問題，制造商應(yīng)專注于與FDA保持清晰、透明和主動的溝通。以下是設(shè)施管理人員可以采取的一些具體措施來確保合規(guī)性。
• Communicate all requests for postponement in writing and include detailed explanations supported by evidence, such as maintenance schedules, emergency reports, and medical documentation for key personnel. Documentation not only demonstrates the company’s commitment to transparency, but also helps to prevent misunderstandings.
以書面形式傳達(dá)所有推遲申請，并附上有證據(jù)支持的詳細(xì)解釋，例如維護(hù)計劃、緊急報告和關(guān)鍵人員的醫(yī)療文件。文件不僅表明了公司對透明度的承諾，還有助于防止誤解。
• If an inspection is postponed for good cause, then provide the FDA with regular updates on the situation. For instance, if a facility is recovering from a cyberattack, updates could include the progress of system restorations and interim measures taken to maintain compliance.
如果檢查因正當(dāng)理由而推遲，則定期向 FDA 提供有關(guān)情況的最新信息。例如，如果設(shè)施正在從網(wǎng)絡(luò)攻擊中恢復(fù)，則更新可能包括系統(tǒng)恢復(fù)的進(jìn)度和為保持合規(guī)性而采取的臨時措施。
• Develop and regularly update an emergency-preparedness plan with protocols for communicating with the FDA during unforeseen events. The plan should outline how a manufacturer will handle situations such as natural disasters, pandemics, and cybersecurity breaches and keep the FDA informed and involved in real-time decision-making.
制定并定期更新應(yīng)急準(zhǔn)備計劃，其中包含在意外事件期間與 FDA 溝通的協(xié)議。該計劃應(yīng)概述制造商將如何處理自然災(zāi)害、流行病和網(wǎng)絡(luò)安全漏洞等情況，并讓 FDA 了解情況并參與實(shí)時決策。
• In complex situations, consult with regulatory experts who can guide your facility in navigating the scenario. Such professionals can assist with drafting communications, preparing documentation, and strategizing responses to meet FDA expectations.
在復(fù)雜情況下，請咨詢監(jiān)管專家，他們可以指導(dǎo)你的設(shè)施駕馭這種情況。這些專業(yè)人員可以協(xié)助起草通信、準(zhǔn)備文件和制定應(yīng)對措施策略，以滿足FDA 的期望。
Maintaining transparency and cooperation during FDA inspections is essential to protecting public health and preserving trust in medical products. Manufacturers should review and update their internal protocols regularly to ensure inspection readiness and foster a culture of compliance. For further guidance, industry professionals should consult the full FDA guidance document referenced below and seek expert advice when necessary. A proactive approach will help facilities to meet their regulatory obligations and uphold the highest standards of product quality and safety.
在 FDA 檢查期間保持透明度和合作對于保護(hù)公眾健康和維護(hù)對醫(yī)療產(chǎn)品的信任至關(guān)重要。制造商應(yīng)定期審查和更新其內(nèi)部規(guī)程，以確保做好檢驗(yàn)準(zhǔn)備并培養(yǎng)合規(guī)文化。如需進(jìn)一步指導(dǎo)，行業(yè)專業(yè)人士應(yīng)查閱下面引用的完整FDA 指導(dǎo)文件，并在必要時尋求專家建議。積極主動的方法將幫助工廠履行其監(jiān)管義務(wù)，并維護(hù)最高的產(chǎn)品質(zhì)量和安全標(biāo)準(zhǔn)。
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