Anatomy of a SOP: How to Write SOPs

The purpose of any Standard Operating Procedure (SOP) is to describe a procedure that can be followed consistently throughout an operation. This allows a company to have uniform ways of performing activities. SOPs form the basis of the company’s Quality System. Learn the basics of what to include if you want to write SOPs.

Free SOP Template examples: https://www.instantgmp.com/solutions/sops

Responsibilities

Initiators are responsible for the creation of the draft procedure using the appropriate templates and routing the SOP for review.

The Quality Assurance team:

  • Oversees the review process.
  • Sets the effective dates as well as the periodic review dates of each SOP.
  • Establishes the review, approval and management of the training program for all SOPs.
  • Manages the Working Instructions and associated forms.

Management is responsible for the review and approval of SOPs (and any related cGxP Forms & Templates).

SOP Content: What to Include when you write SOPs

Header – Title, Document Number and Revision Number.

Purpose – Provides more detail on what the procedure will cover, expanding upon the header.

Scope – Describe to whom and what the procedure applies and any limits of the application.

Responsibilities – Identify the function responsible for ensuring the procedure reflects the current practice. Describes who is responsible for the performance of the procedure and describes the training needed.

References – Identify any policies, procedures, work instructions or regulations that may require cross-referencing while performing the procedure.

Business Requirements – Describe information that broadly applies to the procedure. If there is not general information that pertains to the procedure, this section can be left out.  Use active tense.

Procedure – Describes in block format what to do chronologically or documents a systematic approach for following the SOP or Work Instruction. Identifies functional titles of personnel responsible for performing tasks.  Uses command statements (e.g. Discuss details with the Quality Manager; Finalize the Quality Agreement; Approve the SOP).

Definitions/Acronyms – Identify and define any words or acronyms that require clarity within the procedure.

Forms – List the forms that are identified in the SOP.

Version History – Summarize the revision history of the procedure.  If the procedure replaces another SOP, note it in a section titled “Description of Change”.

Printed procedure will have a watermark identifying the date and expiration of the printed copy.

Review of SOPs

SOPs will be managed and reviewed by Quality biennially (every two years) from the end of the calendar month that the latest revision was placed in effect, or sooner if necessary. 

Note:  Any Forms and/or Templates associated with the SOPs will be evaluated for review at the same time.

Outline of a Typical Procedure

Responsible Party

Action Step

  Creation and Routing of an SOP and/or Working Instruction
Initiator
  1. Draft the procedure following the guidelines in the Business Requirements Section, after obtaining input from key personnel impacted by the procedure.
Document Control Manager
  1. Determine if the procedure is warranted and, if so, assign a number.
  1. Notify the Initiator of the number.
Initiator

 

  1. Route the draft SOP for comments to all personnel impacted by the procedure.  Always include the Document Control Manager, the Quality Manager, and the Departmental Head in the route.
Department Head
  1. Review and comment on the SOP.
Quality Manager
  1. Review and comment on the SOP.
Initiator
  1. Once the draft has been reviewed by affected personnel and is ready for approval; sign and date as the author.
  1. Obtain the approval signatures of the Quality Manager (or delegate).
  Revising and Routing of an SOP and/or Working Instruction
Initiator
  1. Submit a request to change an SOP to the Quality Department through the applicable change procedure.
  1. Incorporate the updates to the SOP and/or Working Instruction revision of the word document.
  1. Route the draft SOP for comments to affected personnel.  Always include Quality and management in the route.
  Approving an SOP and/or Working Instruction
Management

12. Approve the procedure.

13. Select the individuals that require training on the procedure and notify the Document Control Manager.

  1. Determine if a formal training session is required.
Quality Manager

15. Approve the procedure.

Document Control Manager

16. If required, set up a training session for the procedure(s) and notify the trainees.

17. Set the effective date for the procedure(s).  In general, allow two weeks so that training can occur. Each employee, associate or user must be trained before they can use the System or use the SOP.

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