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的缺陷項和觀察項之一。雖然特定的SOP問題通常可以追溯到糟糕的溝通、監控和/或執行，但寫得不好的SOP可能會悄悄地發展成許多其他主要的合規性問題。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，專門用于避免偏差—這是保持合規和交付高質量產品的絕對必要條件。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，這些執行操作的分步說明的目的是確保人員正確和一致地執行操作，以通過統一的性能達到高質量的結果。With this goal in mind, here are a few best practices for writing SOPs based around common problems.帶著這個目標，這里有一些針對常見問題如何編寫SOP的最佳實踐。Writing procedures from the end user's perspective
從最終用戶的角度編寫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SOP應該從實際使用它們的人的角度出發，從純粹實用的角度出發。在編寫以最終用戶為中心的SOP時，請記住以下一些簡單但重要的指導原則。
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.
寫作簡明、清晰，并遵循循序漸進的形式：句子盡可能簡短，使用簡單、常用的術語。當一個更簡單、更清晰的詞或短語表達同樣的意思時，不要使用過于專業或充滿行話的術語來混淆指令的意思。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.用主動語態寫作，首先陳述主旨：注意你寫的內容和你寫的方式。簡單的以行動為導向的動詞，如“識別”、“直接”、“評估”和“審核”，不需要解釋就能表達意思。如果可能的話，在組織句子時不要使用被動語態，因為這已經被證明會混淆和誤導人們對重要思想的注意力。
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：總是避免使用沒有具體意義的泛化術語。像“定期的”、“典型的”、“一般的”和“應該”這樣的詞并不能強制執行任何一致的指示或指令的執行—而這是制定SOP的首要目標。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.注意重要的術語：這里的主要術語是“可能”、“必須”和“應該”。記住，使用“可能”這個詞可以根據上下文賦予個人決策權和/或靈活性。“必須”總是強制性的，而“應該”本質上是有條件的。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。分列的項目和列表對某些信息特別有效，因為它們會集中注意力，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.
標題：這應該包括標題、文件編號和版本。標題應該清楚地標識所討論的活動，并包含任何相關的關鍵詞。(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：目的應定義文件的意圖，不超過一兩句話。它需要足夠詳細，以便最終用戶能夠快速識別文檔所涵蓋的內容，而不包括其他細節。(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或什么方面。許多SOP只涵蓋范圍內的內容，但并沒有說明什么方面不在范圍內，然而，可能兩者都說明是合適的。通過問自己所寫的內容是否有需要解釋的地方來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。通過清楚地說明什么方面和誰在范圍內，誰不在范圍內，你可以讓每個人都有相同的理解起點。(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.參考資料及相關文件：除提供其他SOP外，提供理解并有效執行程序所需的文件和參考資料，或提供SOP參考的政府發布的文件和參考資料。如果您使用主參考文件，請列出所引用文件的標題和任何標識號碼。如果沒有，請提供所引用的全部參考文獻，并使用標準的參考文獻格式。
(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：澄清最終用戶可能不熟悉的任何術語，并拼出所使用的任何首字母縮略詞或縮寫。記住，雖然一個術語對你來說可能很熟悉，但對他們來說可能不熟悉。更重要的是，明確定義的SOP可以幫助監管機構了解您的程序，而無需在檢查期間進行進一步調查。(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：定義負責執行活動的角色。如果列出了大量角色，請考慮縮小范圍并創建多個SOP來完成任務。
(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：請記住，監管機構的工作是讓公司遵守其書面程序中規定的標準，如果這些標準和做法是必要的，并且能夠得到維護。FDA希望確保標準符合合規性期望，而不包含太多可能實際上產生合規性風險的材料。為了避免這種情況，請將該過程分解為以下部分。- Major steps:Your SOP should include only the steps necessary for accomplishing the objective of the procedure.
- 主要步驟：你的SOP應該只包括完成程序目標所必需的步驟。
- Individual action steps within each major step
(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幫助解釋程序，或者對那些直觀學習的人來說效果最好。
(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：記錄對程序所做的更改以及創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.”批準簽名：通常在封面或尾頁。一些SOP需要各種批準簽名。發揮作用的關鍵角色包括作者、審核人、管理層批準人和質量部批準人。值得注意的是，根據21 CFR第211部分，質量部門需要批準所有可能影響“藥品的鑒別、強度、質量和純度”的程序。Advice for SOP Distribution and Comprehension
對SOP分發和理解的建議
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.
根據公司的規模和范圍，單個組織可能管理數百甚至數千個SOP。法規、公司政策或生產過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.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要求公司及時分發SOP，每位員工確認收到并理解SOP。特別是在大型組織中，這需要一個電子數據管理系統(EDMS)。該系統必須符合第11部分的所有監管要求，為程序監控和管理提供安全訪問，并以審計就緒的格式存儲數據，以便監管機構在檢查期間快速獲取數據。"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.“未能遵守書面程序”經常出現在483表格和警告信中，這清楚地表明員工既不理解也不應用必要的知識來履行他們的職責。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程序都應包括測試或評估功能，以確定員工對任何SOP的理解程度。在線測試項目使管理人員能夠立即獲得這些信息，并促進對發現的知識差距作出快速反應。同樣，測試文檔可以向監管機構表明，公司的承諾是有效地教育員工，而不僅僅是文檔分發。點晴模切ERP更多信息：http://moqie.clicksun.cn，聯系電話：4001861886
該文章在 2024/7/23 12:08:48 編輯過
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