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Considerations in GMP Auditing

 

GMP審計(jì)的考慮事項(xiàng)

 

The following is a quick list of things to do as an auditor. Using this list will help you to make sure that you are on track as you plan and conduct GMP audits.

 

以下是作為審計(jì)人員（內(nèi)審/自檢人員或外部審計(jì)人員）需要做的事項(xiàng)列表。使用此列表將幫助你確保在計(jì)劃和進(jìn)行 GMP 審計(jì)時(shí)少走彎路。

 

Maintain and Use a Written SOP for GMP Auditing

 

維護(hù)和使用書(shū)面的GMP審計(jì)SOP

 

Establishing a written audit procedure will help to ensure that all audits are conducted in a consistent manner, and that they meet the minimum requirements. The audit procedure is your roadmap to a successful audit. Some information you could include in an audit procedure might be the frequency of audits, the systems to checked, whether audits are announced or unannounced, and who should be included on the audit team.

 

建立書(shū)面審計(jì)程序?qū)⒂兄诖_保所有審計(jì)都以一致的方式進(jìn)行，并符合最低要求。審計(jì)程序是你成功審計(jì)的路線圖。你可以在審計(jì)程序中包括的一些信息，例如審計(jì)的頻率、要檢查的系統(tǒng)、審計(jì)是通知還是不通知，以及審計(jì)團(tuán)隊(duì)中應(yīng)包括哪些人。

 

Assure Confidentiality of Outcomes

 

確保結(jié)果機(jī)密

 

Assuring the confidentiality of the outcomes of the audit and audit reports is extremely important as an auditor fosters a good relationship with the people you will be auditing. Make sure that they know that you are not trying to embarrass them, or to catch them doing something wrong. Remind them that the purpose of your audit is to check systems to make sure that there are no lapses in quality, and that the results will not be used in a way that publicly targets individuals. In most cases, even the FDA will not be able to look at internal audit results.

 

確保審計(jì)和審計(jì)報(bào)告結(jié)果的機(jī)密性非常重要，因?yàn)閷徲?jì)人員可以與你將要審計(jì)的人員建立良好的關(guān)系。確保他們知道你不是想讓他們難堪，或者抓住他們做錯(cuò)事。提醒他們，你審計(jì)的目的是檢查系統(tǒng)以確保質(zhì)量不會(huì)出錯(cuò)，并且結(jié)果不會(huì)以公開(kāi)針對(duì)個(gè)人的方式使用。在大多數(shù)情況下，即使是FDA也無(wú)法查看內(nèi)部審計(jì)結(jié)果。

 

Use Checklists As Needed

 

必要時(shí)，使用檢查表

 

The checklist is a popular tool to assist the cGMP auditor in conducting a thorough, systematic and consistent audit.A checklist, however, should not be a substitute for proper planning and cooperative climate-setting prior to starting the audit. Consider the advantages of using a well-prepared checklist. It ensures that the auditor will ask most of the critical items necessary to satisfy cGMP requirements, and if properly prepared, it will assist the auditor in focusing on important issues and not becoming absorbed in small details.

 

檢查表是幫助GMP審計(jì)人員進(jìn)行徹底，系統(tǒng)和一致的審計(jì)的常用工具。然而，檢查表不應(yīng)取代開(kāi)始審計(jì)之前的適當(dāng)規(guī)劃和合作氛圍設(shè)定?？紤]使用精心準(zhǔn)備的清單的優(yōu)勢(shì)。它確保審計(jì)人員將詢問(wèn)滿足cGMP要求所需的大部分關(guān)鍵項(xiàng)目，如果準(zhǔn)備得當(dāng)，它將幫助審計(jì)人員專注于重要問(wèn)題，而不是沉迷于小細(xì)節(jié)。

 

Make Sure That All Auditors Have Proper Qualifications

 

確保所有審計(jì)人員都有適當(dāng)?shù)馁Y質(zhì)

 

GMP regulations require that employees be properly qualified (through proper training, education, and experience, or a combination thereof) to do their jobs. It should therefore be documented that auditors are able to properly conduct their duties.

 

GMP法規(guī)要求人員具有適當(dāng)?shù)馁Y質(zhì)（通過(guò)適當(dāng)?shù)呐嘤?xùn)，教育和經(jīng)驗(yàn)，或兩者的組合）來(lái)完成他們的工作。因此，應(yīng)該記錄審計(jì)人員能夠正確履行其職責(zé)。

 

Eliminate Any Conflicts of Interest

 

消除任何利益沖突

 

Integrity is one of the most important characteristics of a good auditor, and maintaining integrity necessitates eliminating any conflicts of interest you may have. The most common conflict of interest to arise for an internal auditor is when he or she has responsibility for an area being audited. External or supplier auditors can face other types of conflicts of interest, including having a family member or friend who works for the company, owning a significant amount of stock in the company, or having previously worked there. If you find yourself in one of these positions, or facing another type of conflict of interest, you must disclose it to management, and in most cases decline to participate in the audit.

 

誠(chéng)信是優(yōu)秀審計(jì)人員最重要的特征之一，保持誠(chéng)信需要消除您可能擁有的任何利益沖突。內(nèi)部審計(jì)人員最常見(jiàn)的利益沖突是當(dāng)他或她對(duì)被審計(jì)的領(lǐng)域有責(zé)任時(shí)。外部或供應(yīng)商審計(jì)人員可能面臨其他類型的利益沖突，包括家庭成員或朋友在該公司工作，擁有該公司的大量股票，或以前在那里工作過(guò)。如果你發(fā)現(xiàn)自己處于這些境地之一，或面臨其他類型的利益沖突，應(yīng)向管理層披露，并且在大多數(shù)情況下拒絕參與審計(jì)。

 

Address Scheduling Issues

 

自檢計(jì)劃

 

When considering when to schedule audits, make sure that you do a GMP audit at least once a year. Also, you will have to decide whether to do an announced or an unannounced audit. Unannounced audits are more common.

 

在考慮何時(shí)安排自檢時(shí)，請(qǐng)確保每年至少進(jìn)行一次GMP自檢。此外，還必須決定是提前通知還是突擊檢查。突擊檢查更為常見(jiàn)。

 

Assume a Cooperative and Non-Confrontational Manner While Auditing

 

在審計(jì)時(shí)采取合作和非對(duì)抗的方式

 

The role of an internal GMP auditor is to assist the company by ensuring that all proper quality and GMP specifications are being properly met. Therefore, work to establish a good working relationship with those you audit. You really should be working with your auditees to protect your customers, to make sure that everyone gets to keep their job, and that the company remains profitable and respected. Do not approach an audit as an opportunity to catch someone messing up, or to embarrass them. Everyone in the company should have the same goals - making products that are safe, pure, and effective. Acting in a cooperative and non-confrontational manner will help you to achieve these goals.

 

內(nèi)部GMP審計(jì)人員的作用是協(xié)助公司確保所有適當(dāng)?shù)馁|(zhì)量和GMP規(guī)范得到適當(dāng)滿足。因此，努力與你的審計(jì)對(duì)象建立良好的工作關(guān)系。你真的應(yīng)該和你的被審計(jì)人員一起保護(hù)你的客戶，確保每個(gè)人都能保住自己的工作，確保公司保持盈利和受人尊敬。不要把審計(jì)當(dāng)成抓住某人搞砸事情或讓他們難堪的機(jī)會(huì)。公司里的每個(gè)人都應(yīng)有相同的目標(biāo)——生產(chǎn)安全、純凈、有效的產(chǎn)品。以合作和不對(duì)抗的方式行事將幫助你實(shí)現(xiàn)這些目標(biāo)。

 

Make Sure That Your Audit Report Is Completed In a Timely Manner

 

確保審計(jì)報(bào)告及時(shí)完成

 

For some auditors, drafting the audit report is the least favorite part of the job. It is time consuming, and it can seem like there is always something more urgent to which you must attend. However, auditors who don't complete audit reports in a timely manner may jeopardize their own professionalism. The sooner you can put the results of an audit on paper, the fresher it will be in your mind. Therefore it is more likely to be accurate if it is done right away. Also, it is important to get the feedback to the people who are affected by the findings as quickly as possible. If the audit findings are presented right away, while it is still fresh in their minds, they will be more likely to take needed corrective action in a timely manner.

 

對(duì)于一些審計(jì)人員來(lái)說(shuō)，起草審計(jì)報(bào)告是工作中最不喜歡的部分。這很耗時(shí)，而且似乎總有更緊急的事情你必須參加。但是，沒(méi)有及時(shí)完成審計(jì)報(bào)告的審計(jì)人員可能會(huì)危及自己的專業(yè)性。你越早將審計(jì)結(jié)果寫(xiě)在紙上，它在你的腦海中就越新鮮。因此，如果立即完成，則更有可能是準(zhǔn)確的。此外，盡快將反饋給到受檢查結(jié)果影響的人員也很重要。如果審計(jì)結(jié)果立即提出，而他們?nèi)匀挥洃洩q新，他們將更有可能及時(shí)采取必要的糾正措施。

 

In The Audit Report, Make Sure That Your Observations Are Fair, Balanced, and Use Non-inflammatory Language

 

在審計(jì)報(bào)告中，請(qǐng)確保你的檢查結(jié)果公平、平衡，并使用非煽動(dòng)性的語(yǔ)言

 

The purpose of an audit is to make your company better at what it does, not to offend fellow co-workers. While sometimes it may be impossible to adequately do the job of an auditor and not offend anyone, you should certainly try to minimize negative feelings and confrontations without compromising the integrity of your work. Making sure that your observations on the audit report are fair, balanced, and don't use unnecessarily inflammatory language will help you to gain the trust of those being audited.

 

審計(jì)的目的是讓你的公司做得更好，而不是冒犯同事。雖然有時(shí)可能無(wú)法充分完成審計(jì)工作而不冒犯任何人，但你當(dāng)然應(yīng)該盡量減少負(fù)面情緒和對(duì)抗，同時(shí)不影響你工作的完整性。確保你對(duì)審計(jì)報(bào)告的觀察是公平、平衡的，并且不使用不必要的煽動(dòng)性語(yǔ)言，將有助于你獲得被審計(jì)者的信任。

 

Plan Corrective Actions and Re-audits, If Necessary

 

如有必要，計(jì)劃糾正措施和重新審計(jì)

 

The last step of an audit is to participate in the planning of corrective action, the time frame in which it will occur, and to schedule a re-audit of deficient areas. This will ensure that improvement results from the findings of the audit.

 

審計(jì)的最后一步是參與糾正措施的計(jì)劃，糾正措施的時(shí)間范圍，并安排對(duì)缺陷領(lǐng)域的重新審計(jì)。這將確保審計(jì)缺陷的改進(jìn)結(jié)果。

 

來(lái)源：ISPE 良好生產(chǎn)規(guī)范（GMP）資源 /GMP審計(jì)的考慮事項(xiàng)