Inadequate standard operating procedures (SOPs) are one of the most frequently cited causes of many deficiencies and observations found in Forms 483 and Warning Letters. And while specific SOP issues can often be traced back to poor communication, monitoring, and/or enforcement, a poorly written SOP can quietly grow into a host of other major compliance problems.
不充分的SOP是許多483表格和警告信中最常見(jiàn)的缺陷項(xiàng)和觀察項(xiàng)之一。雖然特定的SOP問(wèn)題通常可以追溯到糟糕的溝通、監(jiān)控和/或執(zhí)行，但寫(xiě)得不好的SOP可能會(huì)悄悄地發(fā)展成許多其他主要的合規(guī)性問(wèn)題。A well-crafted SOP offers clear direction and instruction specifically designed to avoid deviations—an absolute necessity for maintaining compliance and delivering quality products.精心起草的SOP提供了明確的方向和指令，專(zhuān)門(mén)用于避免偏差—這是保持合規(guī)和交付高質(zhì)量產(chǎn)品的絕對(duì)必要條件。The Basic Components of an Effective SOP
高效SOP的基本組成部分
Quickly touching on the basics, the purpose of these step-by-step instructions for performing operations, is ensuring that personnel perform operations correctly and consistently to achieve a quality outcome through uniform performance.
快速觸及基礎(chǔ)，這些執(zhí)行操作的分步說(shuō)明的目的是確保人員正確和一致地執(zhí)行操作，以通過(guò)統(tǒng)一的性能達(dá)到高質(zhì)量的結(jié)果。With this goal in mind, here are a few best practices for writing SOPs based around common problems.帶著這個(gè)目標(biāo)，這里有一些針對(duì)常見(jiàn)問(wèn)題如何編寫(xiě)SOP的最佳實(shí)踐。Writing procedures from the end user's perspective
從最終用戶(hù)的角度編寫(xiě)SOP
Always remember that SOPs should be written from a purely practical perspective from the point-of-view from those who will actually use them. Here are some simple yet important guidelines to keep in mind to write an end user-focused SOP.
始終記住，編寫(xiě)SOP應(yīng)該從實(shí)際使用它們的人的角度出發(fā)，從純粹實(shí)用的角度出發(fā)。在編寫(xiě)以最終用戶(hù)為中心的SOP時(shí)，請(qǐng)記住以下一些簡(jiǎn)單但重要的指導(dǎo)原則。
Write concisely, clearly, and follow a step-by-step format:Keep sentences as brief as possible and use simple, common terms. Never obfuscate the meaning of an instruction by using overly technical or jargon-filled terminology when a simpler, clearer word or phrase communicates the same idea.
寫(xiě)作簡(jiǎn)明、清晰，并遵循循序漸進(jìn)的形式：句子盡可能簡(jiǎn)短，使用簡(jiǎn)單、常用的術(shù)語(yǔ)。當(dāng)一個(gè)更簡(jiǎn)單、更清晰的詞或短語(yǔ)表達(dá)同樣的意思時(shí)，不要使用過(guò)于專(zhuān)業(yè)或充滿(mǎn)行話(huà)的術(shù)語(yǔ)來(lái)混淆指令的意思。Write in the active voice and present the main idea first:Be mindful of what you write as well as how you write it. Simple action-oriented verbs such as "identify," "direct," "evaluate," and "review" get the point across without requiring interpretation. If at all possible, do not use the passive voice when structuring sentences as this has been shown to confuse and misdirect attention away from important ideas.用主動(dòng)語(yǔ)態(tài)寫(xiě)作，首先陳述主旨：注意你寫(xiě)的內(nèi)容和你寫(xiě)的方式。簡(jiǎn)單的以行動(dòng)為導(dǎo)向的動(dòng)詞，如“識(shí)別”、“直接”、“評(píng)估”和“審核”，不需要解釋就能表達(dá)意思。如果可能的話(huà)，在組織句子時(shí)不要使用被動(dòng)語(yǔ)態(tài)，因?yàn)檫@已經(jīng)被證明會(huì)混淆和誤導(dǎo)人們對(duì)重要思想的注意力。
Avoid ambiguity:Always avoid using generalized terms that give no tangible meaning. Words like "periodic" "typical" "general" and "should" do not enforce any consistent direction or execution of a directive — the main goal of having an SOP in the first place.
避免歧義：總是避免使用沒(méi)有具體意義的泛化術(shù)語(yǔ)。像“定期的”、“典型的”、“一般的”和“應(yīng)該”這樣的詞并不能強(qiáng)制執(zhí)行任何一致的指示或指令的執(zhí)行—而這是制定SOP的首要目標(biāo)。Be careful around important terms:The main terms here are "may," "must," and "should." Remember that using the word "may" gives personnel decision-making power and/or flexibility depending on the context. "Must," is always mandatory and "should" is by nature conditional.注意重要的術(shù)語(yǔ)：這里的主要術(shù)語(yǔ)是“可能”、“必須”和“應(yīng)該”。記住，使用“可能”這個(gè)詞可以根據(jù)上下文賦予個(gè)人決策權(quán)和/或靈活性。“必須”總是強(qiáng)制性的，而“應(yīng)該”本質(zhì)上是有條件的。Make smart use of formatting:If your SOPs consist of long, dense paragraphs, chances are there's a better formatting scheme to follow. Bulleted items and lists are particularly effective for certain pieces of information as they focus attention and slow reader's pace.明智地使用格式：如果您的SOP由長(zhǎng)而密集的段落組成，那么很可能有更好的格式形式可以遵循。分列的項(xiàng)目和列表對(duì)某些信息特別有效，因?yàn)樗鼈儠?huì)集中注意力，減慢讀者的速度。A Model Format for an Effective SOP
有效SOP的模型格式
The model described below lays out the components of an SOP in a way companies can adapt to their own needs and situations.
下面描述的模型以一種公司可以適應(yīng)自己需求和情況的方式列出了SOP的組成部分。
Header: This should include the title, document number and version. The header should clearly identify the activity in question and contain any relevant keywords.
標(biāo)題：這應(yīng)該包括標(biāo)題、文件編號(hào)和版本。標(biāo)題應(yīng)該清楚地標(biāo)識(shí)所討論的活動(dòng)，并包含任何相關(guān)的關(guān)鍵詞。(1.0)Purpose: The purpose should define the intent of the document and be no longer than one or two sentences. It needs to be detailed enough so end users can quickly recognize what the document covers with no other detail included.目的：目的應(yīng)定義文件的意圖，不超過(guò)一兩句話(huà)。它需要足夠詳細(xì)，以便最終用戶(hù)能夠快速識(shí)別文檔所涵蓋的內(nèi)容，而不包括其他細(xì)節(jié)。(2.0) Scope: This defines to whom or what the particular set of procedures applies. Many SOPs cover only what is in scope without stating what is not in scope, however it may be appropriate to state both. Judge the completeness of your scope by asking yourself if what is written leaves anything for interpretation. If the answer is yes, there's likely more work to do. By clearly spelling out what and who is and is not in scope, you offer everyone the everyone to have the same starting point of understanding.范圍：定義特定的一套程序適用于誰(shuí)或什么方面。許多SOP只涵蓋范圍內(nèi)的內(nèi)容，但并沒(méi)有說(shuō)明什么方面不在范圍內(nèi)，然而，可能兩者都說(shuō)明是合適的。通過(guò)問(wèn)自己所寫(xiě)的內(nèi)容是否有需要解釋的地方來(lái)判斷你的范圍是否完整。如果答案是肯定的，可能還有更多的工作要做。通過(guò)清楚地說(shuō)明什么方面和誰(shuí)在范圍內(nèi)，誰(shuí)不在范圍內(nèi)，你可以讓每個(gè)人都有相同的理解起點(diǎn)。(3.0) References and Related Documents: Offer documents and references needed to understand and effectively execute the procedures in addition to other SOPs, or government-issued documents the SOP references. If you use a Master Reference Document, list the title and any identifying numbers for the referenced documents. If not, provide the entire reference cited and use the standard reference format for publishing.參考資料及相關(guān)文件：除提供其他SOP外，提供理解并有效執(zhí)行程序所需的文件和參考資料，或提供SOP參考的政府發(fā)布的文件和參考資料。如果您使用主參考文件，請(qǐng)列出所引用文件的標(biāo)題和任何標(biāo)識(shí)號(hào)碼。如果沒(méi)有，請(qǐng)?zhí)峁┧玫娜繀⒖嘉墨I(xiàn)，并使用標(biāo)準(zhǔn)的參考文獻(xiàn)格式。
(4.0) Definitions: Clarify any terms that may not be familiar to end users and spell out any acronyms or abbreviations that are used. Remember that while a term may be familiar to you, it may not be familiar to them. What's more, a clearly defined SOP can help regulators understand your procedure without requiring further investigation during an inspection.
定義：澄清最終用戶(hù)可能不熟悉的任何術(shù)語(yǔ)，并拼出所使用的任何首字母縮略詞或縮寫(xiě)。記住，雖然一個(gè)術(shù)語(yǔ)對(duì)你來(lái)說(shuō)可能很熟悉，但對(duì)他們來(lái)說(shuō)可能不熟悉。更重要的是，明確定義的SOP可以幫助監(jiān)管機(jī)構(gòu)了解您的程序，而無(wú)需在檢查期間進(jìn)行進(jìn)一步調(diào)查。(5.0) Roles and Responsibilities:Define the roles responsible for executing activities within the procedure. If there are a large number of roles listed, consider narrowing the scope and create multiple SOPs to complete the task.角色和職責(zé)：定義負(fù)責(zé)執(zhí)行活動(dòng)的角色。如果列出了大量角色，請(qǐng)考慮縮小范圍并創(chuàng)建多個(gè)SOP來(lái)完成任務(wù)。
(6.0)Procedure: Remember that regulators work to hold companies to standards set forth in their written procedures if those standards and practices are necessary and capable of being maintained. The FDA wants to ensure that standards meet compliance expectations without containing so much material that it may actually create a compliance risk. To avoid this, break the procedure down into the following components.
程序：請(qǐng)記住，監(jiān)管機(jī)構(gòu)的工作是讓公司遵守其書(shū)面程序中規(guī)定的標(biāo)準(zhǔn)，如果這些標(biāo)準(zhǔn)和做法是必要的，并且能夠得到維護(hù)。FDA希望確保標(biāo)準(zhǔn)符合合規(guī)性期望，而不包含太多可能實(shí)際上產(chǎn)生合規(guī)性風(fēng)險(xiǎn)的材料。為了避免這種情況，請(qǐng)將該過(guò)程分解為以下部分。- Major steps:Your SOP should include only the steps necessary for accomplishing the objective of the procedure.
- 主要步驟：你的SOP應(yīng)該只包括完成程序目標(biāo)所必需的步驟。
- Individual action steps within each major step
- 每個(gè)主要步驟中的單個(gè)行動(dòng)步驟
(7.0) Apendices:These typically work best as a flow chart to aid in explaining the procedures during and audit or for those who learn better visually.
附錄：這些通常作為流程圖來(lái)幫助解釋程序，或者對(duì)那些直觀學(xué)習(xí)的人來(lái)說(shuō)效果最好。
(8.0)Revision History: Record the changes made to a procedure and justification or the reason why the procedure was created.
修訂歷史：記錄對(duì)程序所做的更改以及創(chuàng)建該程序的理由或原因。Approval Signatures: This is usually found on the cover or the back page. Some SOPs require various approval signatures. Key roles in play include the Author, Reviewer, Management Approver, and Quality Reviewer/Approver. It's important to note that Under 21 CFR Part 211, the quality control unit is required to approve all procedures that may impact “the identity, strength, quality, and purity of the drug product.”批準(zhǔn)簽名：通常在封面或尾頁(yè)。一些SOP需要各種批準(zhǔn)簽名。發(fā)揮作用的關(guān)鍵角色包括作者、審核人、管理層批準(zhǔn)人和質(zhì)量部批準(zhǔn)人。值得注意的是，根據(jù)21 CFR第211部分，質(zhì)量部門(mén)需要批準(zhǔn)所有可能影響“藥品的鑒別、強(qiáng)度、質(zhì)量和純度”的程序。Advice for SOP Distribution and Comprehension
對(duì)SOP分發(fā)和理解的建議
Depending on the size and scope of a company, a single organization may manage hundreds or even thousands of SOPs. Any change in regulation, corporate policy, or production process can affect hundreds or thousands of personnel.
根據(jù)公司的規(guī)模和范圍，單個(gè)組織可能管理數(shù)百甚至數(shù)千個(gè)SOP。法規(guī)、公司政策或生產(chǎn)過(guò)程的任何變化都可能影響到成百上千的員工。This is where SOP versioning becomes critically important.這就是為什么SOP版本控制變得至關(guān)重要。The FDA requires companies distributed SOPs in a timely manner and that each employee validate the receipt and understanding of it. Especially in larger organizations, this requires an Electronic Data Management System (EDMS). This system must comply with all Part 11 regulatory requirements, provide secure access for program monitoring and management, and store data in an audit-ready format that is quickly available for regulators during an inspection.FDA要求公司及時(shí)分發(fā)SOP，每位員工確認(rèn)收到并理解SOP。特別是在大型組織中，這需要一個(gè)電子數(shù)據(jù)管理系統(tǒng)(EDMS)。該系統(tǒng)必須符合第11部分的所有監(jiān)管要求，為程序監(jiān)控和管理提供安全訪(fǎng)問(wèn)，并以審計(jì)就緒的格式存儲(chǔ)數(shù)據(jù)，以便監(jiān)管機(jī)構(gòu)在檢查期間快速獲取數(shù)據(jù)。"Failure to follow written procedures" appears frequently in Forms 483 and Warning Letters—a clear indication that employees neither understood nor applied the necessary knowledge to fulfill their responsibilities.“未能遵守書(shū)面程序”經(jīng)常出現(xiàn)在483表格和警告信中，這清楚地表明員工既不理解也不應(yīng)用必要的知識(shí)來(lái)履行他們的職責(zé)。All SOP programs should include testing or evaluation features that establish an employee's level of comprehension for any SOP. Online-based testing programs give managers immediate access to this information and promote a quick response to knowledge gaps when identified. Similarly, testing documentation demonstrates to regulators that a company's commitment is to effective employee education rather document distribution alone.所有SOP程序都應(yīng)包括測(cè)試或評(píng)估功能，以確定員工對(duì)任何SOP的理解程度。在線(xiàn)測(cè)試項(xiàng)目使管理人員能夠立即獲得這些信息，并促進(jìn)對(duì)發(fā)現(xiàn)的知識(shí)差距作出快速反應(yīng)。同樣，測(cè)試文檔可以向監(jiān)管機(jī)構(gòu)表明，公司的承諾是有效地教育員工，而不僅僅是文檔分發(fā)。原文來(lái)自The FDA Group網(wǎng)站。點(diǎn)晴模切ERP更多信息：http://moqie.clicksun.cn，聯(lián)系電話(huà)：4001861886
該文章在 2024/7/23 12:08:48 編輯過(guò)
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