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是许多483表格和警告信中最常见的缺陷项和观察项之一。虽然特定的SOP问题通常可以追溯到糟糕的沟通、监控和/或执行，但写得不好的SOP可能会悄悄地发展成许多其他主要的合规性问题。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提供了明确的方向和指令，专门用于避免偏差—这是保持合规和交付高质量产品的绝对必要条件。The Basic Components of an Effective SOP
高效SOP的基本组成部分
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.
快速触及基础，这些执行操作的分步说明的目的是确保人员正确和一致地执行操作，以通过统一的性能达到高质量的结果。With this goal in mind, here are a few best practices for writing SOPs based around common problems.带着这个目标，这里有一些针对常见问题如何编写SOP的最佳实践。Writing procedures from the end user's perspective
从最终用户的角度编写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.
始终记住，编写SOP应该从实际使用它们的人的角度出发，从纯粹实用的角度出发。在编写以最终用户为中心的SOP时，请记住以下一些简单但重要的指导原则。
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.
写作简明、清晰，并遵循循序渐进的形式：句子尽可能简短，使用简单、常用的术语。当一个更简单、更清晰的词或短语表达同样的意思时，不要使用过于专业或充满行话的术语来混淆指令的意思。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.用主动语态写作，首先陈述主旨：注意你写的内容和你写的方式。简单的以行动为导向的动词，如“识别”、“直接”、“评估”和“审核”，不需要解释就能表达意思。如果可能的话，在组织句子时不要使用被动语态，因为这已经被证明会混淆和误导人们对重要思想的注意力。
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.
避免歧义：总是避免使用没有具体意义的泛化术语。像“定期的”、“典型的”、“一般的”和“应该”这样的词并不能强制执行任何一致的指示或指令的执行—而这是制定SOP的首要目标。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.注意重要的术语：这里的主要术语是“可能”、“必须”和“应该”。记住，使用“可能”这个词可以根据上下文赋予个人决策权和/或灵活性。“必须”总是强制性的，而“应该”本质上是有条件的。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由长而密集的段落组成，那么很可能有更好的格式形式可以遵循。分列的项目和列表对某些信息特别有效，因为它们会集中注意力，减慢读者的速度。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种公司可以适应自己需求和情况的方式列出了SOP的组成部分。
Header: This should include the title, document number and version. The header should clearly identify the activity in question and contain any relevant keywords.
标题：这应该包括标题、文件编号和版本。标题应该清楚地标识所讨论的活动，并包含任何相关的关键词。(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：目的应定义文件的意图，不超过一两句话。它需要足够详细，以便最终用户能够快速识别文档所涵盖的内容，而不包括其他细节。(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.范围：定义特定的一套程序适用于谁或什么方面。许多SOP只涵盖范围内的内容，但并没有说明什么方面不在范围内，然而，可能两者都说明是合适的。通过问自己所写的内容是否有需要解释的地方来判断你的范围是否完整。如果答案是肯定的，可能还有更多的工作要做。通过清楚地说明什么方面和谁在范围内，谁不在范围内，你可以让每个人都有相同的理解起点。(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.参考资料及相关文件：除提供其他SOP外，提供理解并有效执行程序所需的文件和参考资料，或提供SOP参考的政府发布的文件和参考资料。如果您使用主参考文件，请列出所引用文件的标题和任何标识号码。如果没有，请提供所引用的全部参考文献，并使用标准的参考文献格式。
(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.
定义：澄清最终用户可能不熟悉的任何术语，并拼出所使用的任何首字母缩略词或缩写。记住，虽然一个术语对你来说可能很熟悉，但对他们来说可能不熟悉。更重要的是，明确定义的SOP可以帮助监管机构了解您的程序，而无需在检查期间进行进一步调查。(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.角色和职责：定义负责执行活动的角色。如果列出了大量角色，请考虑缩小范围并创建多个SOP来完成任务。
(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：请记住，监管机构的工作是让公司遵守其书面程序中规定的标准，如果这些标准和做法是必要的，并且能够得到维护。FDA希望确保标准符合合规性期望，而不包含太多可能实际上产生合规性风险的材料。为了避免这种情况，请将该过程分解为以下部分。- Major steps:Your SOP should include only the steps necessary for accomplishing the objective of the procedure.
- 主要步骤：你的SOP应该只包括完成程序目标所必需的步骤。
- 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.
附录：这些通常作为流程图来帮助解释程序，或者对那些直观学习的人来说效果最好。
(8.0)Revision History: Record the changes made to a procedure and justification or the reason why the procedure was created.
修订历史：记录对程序所做的更改以及创建该程序的理由或原因。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.”批准签名：通常在封面或尾页。一些SOP需要各种批准签名。发挥作用的关键角色包括作者、审核人、管理层批准人和质量部批准人。值得注意的是，根据21 CFR第211部分，质量部门需要批准所有可能影响“药品的鉴别、强度、质量和纯度”的程序。Advice for SOP Distribution and Comprehension
对SOP分发和理解的建议
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.
根据公司的规模和范围，单个组织可能管理数百甚至数千个SOP。法规、公司政策或生产过程的任何变化都可能影响到成百上千的员工。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要求公司及时分发SOP，每位员工确认收到并理解SOP。特别是在大型组织中，这需要一个电子数据管理系统(EDMS)。该系统必须符合第11部分的所有监管要求，为程序监控和管理提供安全访问，并以审计就绪的格式存储数据，以便监管机构在检查期间快速获取数据。"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.“未能遵守书面程序”经常出现在483表格和警告信中，这清楚地表明员工既不理解也不应用必要的知识来履行他们的职责。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程序都应包括测试或评估功能，以确定员工对任何SOP的理解程度。在线测试项目使管理人员能够立即获得这些信息，并促进对发现的知识差距作出快速反应。同样，测试文档可以向监管机构表明，公司的承诺是有效地教育员工，而不仅仅是文档分发。点晴模切ERP更多信息：http://moqie.clicksun.cn，联系电话：4001861886
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