SOP for writing/drafting SOP (Standard Operating Procedure)

K

kashraasch

Hello all,
I work for a Pharmaceutical company and looking for examples of SOP for SOPs. I have one but I want to modifiy where each dept. has there own QA associate who would be responsible for maintaining there own copy of SOP and keeping the versions uptodate.

just wanted to see if anyone else has this in there SOP.

Thank you so much, Love this site,

Kaushal
 

Marc

Fully vaccinated are you?
Leader
Re: SOP for SOP (Standard Operating Procedure)

An SOP for what? Document Control?
 
K

kashraasch

Re: SOP for SOP (Standard Operating Procedure)

SOP for all the other SOPs on how to write them what the format and numbering system would be. How SOPs would get approved and reviewed. Who all will be trained on these SOPs extra..

Sorry for incomplete question.

Kaushal
 

harry

Trusted Information Resource
Re: SOP for SOP (Standard Operating Procedure)

Welcome to the Cove,

You can have an idea how most SOPs are structured by looking at the files in our post attachments list - search using 'SOP' as keyword.

With regards to numbering, there is no necessity or specific guidelines - practically up to you. My preference is just to name it, without all the fancy looking numbering.

With regards to an SOP for drafting sops, there is no requirement. You can briefly outlined it in your document control procedure.
 
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S

sudwel

Hello all,
I work for a Pharmaceutical company and looking for examples of SOP for SOPs. I have one but I want to modifiy where each dept. has there own QA associate who would be responsible for maintaining there own copy of SOP and keeping the versions uptodate.

SOP for all the other SOPs on how to write them what the format and numbering system would be. How SOPs would get approved and reviewed. Who all will be trained on these SOPs extra..

You could address these issues in two separate SOPs - one, an SOP on how to write SOPs and a second for document management - as it sounds like you have elements of both in your question.

In my previous employment, where we had ISO for the entire company, and then 4 other department-specific quality programs (one for 17025, one for compliance with a Certificate of Approval, one to have Certificates of Authorization and one for Engineering... don't ask - but they were all necessary!) - we had a general document management procedure that detailed how the ISO QMS procedures/forms were managed, with an more specific procedure that got into nomenclature, revision tracking, approvals etc.. Then, each department-specific quality manual either referenced the corporate procedures (if applicable) or had an even more specific procedure - an SOP on how to write an SOP! This one was very detailed indicating things like:
- title page layout
- procedure numbering
- heading numbering
- font style, font size
- line spacing, margins, borders
- section headings (i.e. 1. Purpose, 2. Safety, 3. Responsibilities, 4. Procedure specifics, 5. Related Documents and Records)
- review frequency and approvals
- how to make changes (we allowed red pen changes to working copies, with any red pen changes incorporated into a full revision/reissue annually)
- who's responsible for "field copies", including incorporating changes etc.

Hope this helps - just my :2cents:!

Darlene
 
M

Mike Scott

Section Headings can vary depending on SOP contents.

One rule of thumb I use, when required, is to restate the Code/Standard/Regulatory Requirements in the "Purpose" section. This guides me through completing a fully developed, compliant and useful SOP.

Mike :cool:
 

Pancho

wikineer
Super Moderator
Hello all,
I work for a Pharmaceutical company and looking for examples of SOP for SOPs. I have one but I want to modifiy where each dept. has there own QA associate who would be responsible for maintaining there own copy of SOP and keeping the versions uptodate.

just wanted to see if anyone else has this in there SOP.

Here's an excerpt of our own "SP: New Documents" procedure. Underlines indicate links in our procedure.

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D. Procedure

  1. Detect the need for a document: When (a) a new activity is started, or (b) a bug reveals that documentation for a particular activity is missing (see SP: Continuous Improvement), or (c) an employee detects that an activity relevant to our delivery of a quality product has not been documented, then the proper method to perform such activity shall be described in a document as per this procedure. But before writing a new document you should check if no other document exists already that describes such activity (in case such document exists, then that existing document shall be modified as may be required, in lieu of preparing a new document). To perform such check, conduct a search in the following wiki spaces:
    • QMS,
    • general wiki,
    • Safety,
    • Certain Administrative and Engineering documents may exist in Administration or Armadura.
    • Records are a special type of document. Instructions in Record Forms take precedence over instructions here.

  2. Open a wiki page by adding the links in the index and navigation pages: The person that detects the need of the new document or the person assigned to resolve the applicable bug opens the wiki page for the new document:
    • Name the new document in accordance with SP: Document Identification.
    • Add a link in the applicable index by editing the index page and adding the document name in square brackets (i.e. "[AA: DocName]"). Upon adding this link, the wiki software automatically creates the link to a new blank page named "[AA: DocName]". Index pages are listed in Home and in the navigation bar at the top of all wiki pages.
    • Add a link to the relevant navigation pages. Navigation pages are linked from the Index pages.

  3. Appoint an initial author for the document: Each new document in the Management System shall be drafted by a person experienced in the activity to document. This person is the "initial author", and may be any one of the following provided that he or she knows the activity:
    • The person that created the new wiki page,
    • The person assigned to resolve the relevant bug,
    • The manager of the process or functional area to which the document applies (or whomever this manager designates), or
    • The person appointed by the MS Committee.

  4. Appoint a person in charge of the new document: The manager of the process or functional area to which the document applies shall be appointed as the person in charge of the new document, and he or she may later delegate the charge to someone that reports to him or her. The person in charge of a document must monitor and control the document following the SP: Document Control. List the person in charge of the document where applicable within the document (scroll down to the Annexes for the proper place in the different types of documents).

  5. Write the Content: Open the new wiki page, click on "edit this page", and type the document. Content shall preferably be as follows:
    1. Text in editable form, and not as an image or pdf.
    2. Tables in wiki format.
    3. After all images of charts or other graphic content, include the source file to produce the graphic content.
    4. Photos shall be displayed as viewable as images, not as attachment files.
    5. References to other documents shall be added as active links.
    6. When adding files:
      • Use "Attach File", and do not compress the file.
      • Verify that the upload worked by downloading the file.
      • Certain file types may not be compatible with the wiki. In such cases, zip the file and upload as a .zip.
    7. Do not duplicate content already existing in other system documents. Instead of duplication, use links and includes.
    8. Annexes describe the minimal content for the most common document types in the Management System.

  6. Add the navigation menu to the new document. Simply add [nav:start][include: Nav Area][nav:end] at the beginning of the document, substituting "Area" for the name of the Process to which the document belongs.

  7. Maintenance of the Document: every document in the Management System is maintained and controlled in accordance with SP: Document Control and improved following SP: Continuous Improvement.
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As you can tell from the SOP, we use a wiki-based system.

Hope it helps, and good luck!

Pancho
 
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