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近日，歐洲藥品管理局EMA更新了關(guān)于第三方審計(jì)的GMP問答，如下：

 

What are the expectations for the content of written final assessment ofthird-party audit reports? H+V New Apr 2025

對(duì)第三方審計(jì)報(bào)告的書面最終評(píng)估內(nèi)容有何要求？

 

 

The QP has the ultimate responsibility to ensure that audit reports are properly evaluatedwhen the audit is performed by a third party. The written final assessment document should provide a comprehensible summary of this evaluation and should be readily available and shared with authorities, if requested.

 

QP 負(fù)有最終責(zé)任，確保在第三方執(zhí)行審計(jì)時(shí)，審計(jì)報(bào)告得到適當(dāng)評(píng)估。書面最終評(píng)估文件應(yīng)提供該評(píng)估的易于理解的摘要，并應(yīng)隨時(shí)可用，并在需要時(shí)向當(dāng)局提供。

 

The assessment should include all expected elements of the auditing process and auditreport(s) identified before, during and after the audit. In particular, this includes verification of contractual arrangements, scope and appropriate duration of audit, adequate competence of auditors considering the scope of the audit, planned audit frequency, and CAPAs whether adequate and how these are to be followed up. Any conflicts of interest identified should be discussed.

 

評(píng)估應(yīng)包括審計(jì)過程的所有預(yù)期要素以及審計(jì)之前、期間和之后確定的審計(jì)報(bào)告。特別是，這包括確認(rèn)合同安排、審計(jì)范圍和適當(dāng)?shù)某掷m(xù)時(shí)間、審計(jì)人員考慮所審計(jì)范圍的足夠能力、計(jì)劃的審計(jì)頻率以及CAPA 是否足夠以及如何跟進(jìn)。應(yīng)討論發(fā)現(xiàn)的任何利益沖突。

 

Is an audit performed by a third party acceptable? H+V New Apr 2025

是否可以接受第三方進(jìn)行的審計(jì)？

 

 

The document 'guidance on the occasions when it is appropriate for competent authorities to conduct inspections at the premises of manufacturers of active substances used as starting materials', published as part of the Union procedures, states that it is expected that manufacturing-authorisation holders will gain assurance that the active substances they use are manufactured in accordance with GMP through audit of the active-substance suppliers. Article 46 (f) of Directive 2001/83/EC states: "The holder of the manufacturing authorisation shall verify such compliance either by himself or, without prejudice to his responsibility as provided for in this Directive, through an entity acting on his behalf under a contract". Manufacturers may not have the necessary expertise or resources to conduct their own audits and therefore may contract with third parties to undertake relevant audits. MIA holders may rely on audits carried out by active substance manufacturers on their suppliers of active substance intermediates provided that there is an appropriate contractual arrangement in place between the MIA holder and the manufacturer of the active substance.

 

作為歐盟程序的一部分發(fā)布的文件“關(guān)于主管當(dāng)局在用作起始材料的活性物質(zhì)制造商的場(chǎng)所進(jìn)行檢查的適當(dāng)情況指南”指出，要求生產(chǎn)許可持有人將通過對(duì)活性物質(zhì)供應(yīng)商的審計(jì)來確保他們所使用的活性物質(zhì)是按照GMP 生產(chǎn)的。第 2001/83/EC 號(hào)指令第 46 （f） 條規(guī)定：“生產(chǎn)許可的持有人應(yīng)自行確認(rèn)此類合規(guī)性，或者在不影響其責(zé)任的情況下，通過委托代表其行事的實(shí)體進(jìn)行確認(rèn)”。制造商可能不具備必要的專業(yè)知識(shí)或資源來進(jìn)行自己的審計(jì)，因此可能會(huì)與第三方簽訂合同進(jìn)行相關(guān)審計(jì)。MIA 持有人可以依賴活性物質(zhì)制造商對(duì)其活性物質(zhì)中間體供應(yīng)商進(jìn)行的審計(jì)，前提是 MIA 持有人與活性物質(zhì)制造商之間有適當(dāng)?shù)暮贤才拧?/span>

 

Section 5.27 of the GMP guideline requires that the selection, qualification, approval and maintenance of suppliers of starting materials, together with their purchase and acceptance, are performed by staff that have a current knowledge of the suppliers, the supply chain and the associated risks involved.

 

GMP 指南第 5.27 節(jié)要求起始材料供應(yīng)商的選擇、確認(rèn)、批準(zhǔn)和維護(hù)，以及起始物料的采購(gòu)和驗(yàn)收，由對(duì)供應(yīng)商、供應(yīng)鏈和所涉及的相關(guān)風(fēng)險(xiǎn)有最新了解的人員進(jìn)行。

 

An audit conducted by the manufacturing-authorisation holder itself should be integral to the manufacturer's quality-assurance system and subject to the basic GMP requirements, i.e. conducted by properly qualified and trained staff, in accordance with approved procedures. It should be properly documented. These aspects can be inspected as necessary by the competent authorities.

 

由生產(chǎn)許可持有人本身進(jìn)行的審計(jì)應(yīng)是制造商質(zhì)量保證體系的組成部分，并受 GMP 基本要求的約束，即由具有適當(dāng)資質(zhì)和培訓(xùn)的人員按照批準(zhǔn)的程序進(jìn)行。它應(yīng)該被適當(dāng)?shù)赜涗浵聛怼Ｖ鞴墚?dāng)局可以根據(jù)需要檢查這些方面。

 

If a third party is involved, the arrangements should be subject to chapter 7 of the GMP guideline. There should be evidence that the contract-giver has evaluated the contract-acceptor with respect to the aspects described above.

 

如果涉及第三方，則此類安排應(yīng)符合 GMP 指南第 7 章的規(guī)定。應(yīng)有證據(jù)表明合同提供方已經(jīng)就上述方面對(duì)合同接受方進(jìn)行了評(píng)估。

 

All parties involved should be aware that audit reports and other documentation relating to the audit will be made available for inspection by the competent authorities if requested. This should normally provide sufficient assurance that the results of an audit carried out by the third party are credible, thus waiving the need for an audit conducted by the manufacturing-authorisation holder itself. A third-party contractual arrangement may lead to a conflict of interest arising on the part of one or more of the parties involved. Conflicts of Interest should be regarded as any influencing factor that may affect the judgement of the auditor resulting in an audit report that may not provide a full and impartial assessment against EU GMP requirements.

 

所有相關(guān)方都應(yīng)注意，如果主管當(dāng)局要求，將提供審計(jì)報(bào)告和其他與審計(jì)相關(guān)的文件供其檢查。這通常應(yīng)提供足夠的保證以證明第三方進(jìn)行的審計(jì)結(jié)果是可信的，以免除由生產(chǎn)許可持有人自己進(jìn)行審計(jì)的需要。第三方合同安排可能會(huì)導(dǎo)致相關(guān)一方或多方產(chǎn)生利益沖突。利益沖突應(yīng)被視為可能影響審計(jì)人員判斷的任何影響因素，從而導(dǎo)致審計(jì)報(bào)告可能無法根據(jù)GMP 要求提供全面和公正的評(píng)估。

 

Therefore, the MIA holder should ensure that there are arrangements in place to assure that any conflicts of interests are declared, and where declared, that they are assessed for their impact on the impartiality of the audit.

 

因此，MIA 持有人應(yīng)確保有適當(dāng)?shù)陌才艁砺暶魅魏卫鏇_突，并評(píng)估其對(duì)審計(jì)公正性的影響。

 

Potential conflicts of interest may arise from diverse sources and may include for example:

 

潛在的利益沖突可能來自不同的來源，例如可能包括：

 

An auditor who declares that they have financial, family or social links to the company being audited.

 

聲明與被審計(jì)公司有財(cái)務(wù)、家庭或社交聯(lián)系的審計(jì)人員。

 

An auditor who declares that they have previously worked for the company being audited and who may be presented with documents during the audit that were issued, reviewed or approved by them.

 

聲明以前曾為被審計(jì)公司工作的審計(jì)人員，并且在審計(jì)期間可能會(huì)收到曾經(jīng)由他們簽發(fā)、審查或批準(zhǔn)的文件。

 

Contract auditors or companies who declare that they stand to make commercial gain from sale or supply of an audit report (particularly to sharing of audit reports between different manufacturing-authorisation holders using the same active substance supplier).

 

合同審計(jì)人員或公司，聲稱其可以通過銷售或提供審計(jì)報(bào)告以獲得商業(yè)利益（特別是在使用同一活性物質(zhì)供應(yīng)商的不同生產(chǎn)許可持有人之間共享審計(jì)報(bào)告）。

 

Auditors who declare that they stand to gain financially from a successful audit outcome, e.g. by payment of bonus or payment only on successful outcome or persons contracted as consultants (to advise) rather than specifically to conduct an impartial audit.

 

宣稱其將從成功的審計(jì)結(jié)果中獲得經(jīng)濟(jì)利益的審計(jì)人員，例如通過支付獎(jiǎng)金或僅在成功的結(jié)果中付款，或簽約擔(dān)任顧問（提供建議）而不是專門進(jìn)行公正審計(jì)的人員。

 

Definition of API starting materials, and hence which steps to perform under GMP, is a critical aspect where conflicts of interest may arise, especially in cases where an API intermediate is manufactured at a site different from the final API manufacturing site.

 

API 起始物料的定義，以及哪些步驟按照 GMP 執(zhí)行，是可能產(chǎn)生利益沖突的一個(gè)關(guān)鍵方面，尤其是在 API 中間體的生產(chǎn)地點(diǎn)與最終API 生產(chǎn)地點(diǎn)不同的情況下。

 

In addition to the arrangements to assure that conflicts of interest are declared, each auditing body should have a quality system that supports the quality and integrity of audits.

 

除了確保聲明利益沖突的安排外，每個(gè)審計(jì)機(jī)構(gòu)還應(yīng)有一個(gè)支持審計(jì)質(zhì)量和完整性的質(zhì)量體系。

 

Where a conflict of interest has been declared by a third-party auditor or contracting company, they should document the nature of the conflict of interest, the impact it may have on the conduction of the audit and how the overall assessment of the GMP compliance status of the auditee is assured.

 

如果第三方審計(jì)人員或公司聲明存在利益沖突，他們應(yīng)記錄利益沖突的性質(zhì)、它可能對(duì)審計(jì)實(shí)施產(chǎn)生的影響以及如何確保對(duì)受審計(jì)方的 GMP 合規(guī)狀態(tài)進(jìn)行總體評(píng)估。

 

This topic should be addressed in the technical contractual arrangements. Any measures taken by the contract-giver should be documented, e.g. signed undertakings by the auditors. The absence or presence of conflicts of interest on the part of auditors or contracting parties should be identified.

 

這一主題應(yīng)在技術(shù)合同安排中解決。合同提供方采取的任何措施都應(yīng)記錄在案，例如由審計(jì)人員簽署承諾書。應(yīng)確定審計(jì)人員或受托方是否存在或不存在利益沖突。

 

QPs should ensure that the written final assessment and approval of third-party audit reports includes an evaluation of a declaration or absence of any conflicts of interest made by auditors and/or the contracting parties.

 

QP應(yīng)確保第三方審計(jì)報(bào)告的書面最終評(píng)估和批準(zhǔn)包括對(duì)審計(jì)人員和/或受托方所做的聲明或不存在任何利益沖突的評(píng)估。

 

Conflicts of interest may come to light after the QP has relied upon a third-party audit report and it may be necessary for the QP to undertake a retrospective assessment.

 

利益沖突可能會(huì)在 QP 簽署第三方審計(jì)報(bào)告后暴露出來，QP 可能需要進(jìn)行回顧性評(píng)估。

 

The principles outlined above could be used in case of joint audits between different manufacturing authorisation holders or in those cases where the drug manufacturers have jointly contracted the third party auditor and have signed the contract before the audit took place, using the same active substance supplier, provided that the scope of the audits can be shown to be applicable to the active substances of mutual interest.

 

上述原則可用于不同生產(chǎn)許可持有人之間的聯(lián)合審計(jì)，或者多個(gè)藥品制造商與第三方審計(jì)人員共同簽約并在審計(jì)前已經(jīng)簽約，使用同一活性物質(zhì)供應(yīng)商的情況，前提是審計(jì)的范圍可以證明適用于共同關(guān)心的活性物質(zhì)。