关于SOP的11个问题

[所属分类:技术资料] [发布时间:2020-6-1] [发布人:] [阅读次数:] [返回]

山东拓普生物工程有限公司

Shandong Tuopu Biol-Engineering Co.,Ltd

关于SOP的11个问题

Question: Howoften should I review my SOPs?

问1：我应该多久审核一次 SOP？

Answer: SOPs should be reviewed at leastevery two years. If an SOP is revised in between the two-year window, it shouldbe reviewed thoroughly at the time of a revision. If the proposed revisionaffects related SOPs, they should also be reviewed for impact before the SOPrevision is made affective.

答：至少每两年审核一次 SOP。如果在这两年中间修订了SOP，则应在修订时对其进行彻底审查。如果修订影响了其他相关的 SOP，则在 SOP 修订生效之前，还应对其他相关SOP进行审查。

Question: How manySOPs should I have in my system?

问2：体系需要多少个SOP？

Answer: There is no set rule or formularegarding the number of SOPs needed for afunctioning system.The number of SOPs needed depends on the activities the company is performing.We recommend writing SOPs that reflect your operations and avoid having SOPs inyour system for operations you do not perform.

答：对于一个有效运转的系统所需的SOP 数量，没有固定的规定或公式。所需的SOP数量取决于公司所执行的操作。我们建议编写反映操作的SOP，并避免用于不执行的操作的SOP。

Question: Whatformat do you recommend for SOPs?

问3： SOP 推荐什么格式？

Answer: There is no one correct formatfor SOPs. The format you chose will depend on the operation you are definingand the  experience and makeup of your workforce. Acceptable formats forSOPs include using play script, general paragraph form, flow charts, pictorialor any combination to communicate the SOP operation to the workforce. Whateverstyle you decide to use be sure that your SOP format includes the followingrecommended elements:

答：SOP 没有唯一的正确格式。所选择的格式将取决于你正在定义的操作以及员工的经验和组成。SOP 可接受的格式包括使用剧本、常规段落形式、流程图、图片或其任意组合，以将 SOP 操作传达给员工。无论决定使用哪种样式，确保你的 SOP 格式包含以下建议的要素：

• Unique identifying number and title

• 唯一的编号和标题

• Effective date

• 生效日期

• Purpose and scope

• 目的和范围

• Roles and responsibilities

• 角色和责任

• Change history

• 变更历史

• Official signatures

• 正式签名

• Step-by-step instructions

•  操作步骤说明

 

Question: What doI do when I obsolete an SOP?

问4：废除SOP 时我该怎么办？

Answer: You should only obsolete an SOPif your company is no longer performing the activity described by the SOP. TheSOP should be obsoleted using the change control system. It is critical thatyou review SOPs related to the one you are obsoleting and determine if theyneed revision as a result of the obsoleted SOP. The obsoleted SOP and associatedforms should remain on file in case they need to be referred to but they shouldclearly be stamped as being obsoleted.

答：仅当公司不再执行 SOP 描述的活动时，才应废除该 SOP。应使用变更控制系统废除 SOP。重要的是，审阅与拟废除 SOP 相关的其他SOP 并确定其是否由于该SOP废除而需要同时修订。废除的 SOP 和相关表单仍应保留存档以备查阅，但应标记为“以作废”。

Question: How muchtime should I allow for training on SOPs?

问5：我应该留出多少时间进行 SOP 培训？

Answer: There is no set time regardingthe amount of time allowed for training on SOPs. The amount of time needed totrain on an SOP depends on your operation. Companies with multiple sitesaffected by the SOP may need additional time to train than a smaller companywith just one site. We recommend, as a general rule, that you allow two weeksto train on an SOP.

答：关于 SOP 的培训时间没有硬性规定。SOP 培训所需的时间取决于你的操作。与只有一个工厂的小型公司相比，一个大的公司的多个工厂受 SOP 影响时，可能需要更多时间进行培训。一般情况下，我们建议给出两周的时间进行SOP培训。

 

Question: What isthe difference between a release date and an effective or official date?

问6：发布日期与生效日期或正式日期有何区别？

Answer: The release date for an SOPindicates that the necessary revisions have been approved and the SOP is readyand available for training. Once the training is complete and documented, theSOP can be made official and used by the employees performing the describedoperation. We recommend, as a general rule, that you allow two weeks to trainon an SOP before you make it official.

答：SOP 的发布日期表示必要的修订已得到批准，且 SOP 已准备就绪，可供培训。培训完成后，SOP 可以生效，并由执行所述操作的员工使用。一般情况下，我们建议在生效之前允许两周时间培训SOP 。

Question: Should acompany use the same date format whatever it decides or can a variety offormats be used provided the date is clear and legible?

问7：公司都应该使用相同的日期格式，或者如果日期清晰易读，是否可以使用多种格式？

Answer: Dictating one date format versusanother can create unnecessary and irrelevant deviations. The requirements forthe date are that it should be legible and readable.

答：任意日期格式可能会造成不必要和不相关的偏差。日期的要求是，它应该是易读易懂的。

Question: Whenpictorials are used, is it recommended to reference the SOP number?

问题8：使用图片时，是否建议引用SOP 编号？

Answer: Yes. This will make it much easierto track the documents for necessary revisions.

答：是的。这有助于追溯文件以便于必要的修订。

Question: Areelectronic signatures acceptable on SOPs?

问9：SOP 上是否可以接受电子签名？

Answer: Yes, electronic signatures areacceptable on SOPs. We recommend that if you have electronic signaturecapabilities be sure you comply to 21 CFR 11 and can provide an audit trailupon request. In addition, we recommend that individuals who have the authorityto approve SOPs electronically have a unique account and password to avoid anydata integrity issues.

答：是的，在 SOP 上电子签名是可以接受的。我们建议，如果有电子签名功能，请确保您符合 21 CFR 11，并可以提供审计追踪。此外，我们建议具备电子批准 SOP权限的个人拥有唯一的帐户和密码，以避免任何数据完整性问题。

Question: Can youhave two different expiry dates? For example, SOPs for instruments reviewedevery four years and SOPs regarding quality systems (OOS, OOT, change control,audits) every two years.

问10：可以有两个不同的复审期吗？例如，仪器的 SOP 每四年复审一次，而与质量系统（OOS、OOT、变更控制、审计）的 SOP 每两年审查一次。

Answer: Yes, you can have two differentreview periods for various SOPs in the system. You should document yourrationale for why you have chosen these time frames for review. However,whether you review your SOPs on a two-year or four-year cycle, SOPs revised inbetween the defined cycle should be reviewed thoroughly at the time of a revision.If the proposed revision affects related SOPs, they should also be reviewed forimpact before the SOP revision is made affective, regardless of what cycleperiod they are on.

答：可以，系统中的各种 SOP 可以有两个不同的复审周期。应该记录选择这些周期进行复审的理由。但是，无论是在两年还是四年周期内审查你的 SOP，在规定周期之内修订 SOP 时，都应在修订时进行彻底审查。如果该修订影响其他相关的 SOP，则应在 SOP 修订生效之前，审查它们的影响，而不管它们处于哪个周期。

Question: Is therean expectation that the change history be contained within the SOP?

问11：是否要求在SOP中包含变更历史记录？

Answer: Common industry practice is toinclude the change history of the SOP within the document but there is norequirement that you must include it in the document. If you chose not toinclude the change history in the document be sure you capture it in a controlledsystem that is available for answering questions during an inspection or audit.

答：常见的行业做法是在文件中包含 SOP 的变更历史记录，但不是强制要求。如果选择不在文件中包含变更历史记录，应确保将其捕获到受控系统中，以在检查或审计期间用于回答问题。