Best practices for creating Standard Operating Procedures (SOPs)

One key element in establishing Good Manufacturing Practices (GMPs) is training and managing team members. Standard operating procedures (SOPs) help to support this requirement, as they establish instructions to onboard new members and train them on the equipment, workflows, and documentation needed to manufacture pharmaceutical products, ensure consistent quality of work, and fulfill regulatory expectations. In this article, we define some best practices for creating SOPs that can be adapted based on the specific needs and context of pharmaceutical manufacturers.

Avoid drafting SOPs under pressure

When organizations spend little time writing standard operating procedures, the result is a text that is unclear, repetitive or not thoroughly reviewed and discussed across different teams. Sometimes, companies establish SOPs to close corrective and preventive actions (CAPAs). While during follow-ups inspectors may appreciate the use of CAPA wording, these SOPs may be less practical and force personnel to learn from observation rather than from the written procedural methods. While SOPs are a great tool to achieve consistency, this depends on how easy they are to understand and ‌follow. Thus, developing effective standard operating procedures is a delicate task that requires companies to draft and edit a concise set of instructions and appendices. In addition, the time spent on constructive reviews and discussions helps to ensure that the final version of the SOP is relevant, understandable and also aligns with the general Quality Management System (QMS) and other effective procedures.

Write SOPs from the end user’s perspective

To ensure user compliance, SOP must be written practically and be easy to understand by the end users. Simple phrasing is preferred over technical or jargon-filled language. SOPs should provide a clear understanding of how the process should run within the company, and who handles specific activities should be listed in the procedure.In addition, standard operating procedures should be written in an active voice without requiring interpretation from the end user, and clearly differentiate between what is mandatory and what is not. Beyond precise sentence construction, the SOP text must be organized as neatly as possible by breaking down information through bulleted and numbered lists. 

Follow a format to create SOPs

Following a model to draft SOPs enables companies to cover a variety of processes while also establishing a common system for documentation and management. The basic elements of a standard operating procedure are:

• Header: This section should include the title, document number, SOP version, relevant keywords, and the activity addressed.

• Purpose: Consisting of up to two sentences stating the intent of the document so end users can easily know what the document covers without needing to read any further.

• Scope: This section specifies to whom and to what this SOP applies.

• References and Related Documents: It encompasses all the documents and references required to implement the procedures described, understand the context of the SOP, and navigate to referenced procedures easily. If the company is using a Master Reference Document, the referenced documents must be identified by their title and identifying number. If this is not the case, the full reference (in standard reference format) should be used.

• Definitions: Any terms, acronyms, and abbreviations that might not be known by the end users and regulators are included in this part.

• Roles and Responsibilities: The roles responsible for implementing the procedures should be listed and defined.

• Procedure: Each SOP must include the major steps critical to achieving its objective, the individual steps that make up each major step, clarifying notes, and related warnings.

• Appendices: To aid visual learners in understanding the processes described, this section usually features the SOP’s flow chart and reference images. It also can include templates for any registry or logbooks that are described in the procedure.

• Revision History: Any changes made to an SOP must be logged, including the reason the document was updated. Periodic reviews of SOPs are a must. While they are usually required to be performed every two years, additional reviews may be needed if the covered activities are updated.

• Approval Signatures: This section is usually placed on the SOP’s cover or back page, and includes the signatures of key roles involved in the creation and implementation of the SOP such as author, reviewer, management representative, and quality reviewer.

If a standard operating procedure starts to become too complex, a solution is to break it into a parent SOP with child SOPs with their own procedures and appendices.

Ease SOPs implementation by promoting order and congruency

The U.S. Food and Drug Administration requires that SOPs be distributed in a timely manner, which in the case of larger organizations calls for establishing an Electronic Data Management System (EDMS).  This system must provide secure access to program monitoring, store data in a format that preps it for potential audits, and meet all 21 CFR Part 11 regulations.

Maintaining a consistent understanding of a standard operating procedure across the organization is key. To achieve this, SOPs should be hard copies or non-editable files stored in a secure location. Editable files may be circulated prior to approval, but must not be disseminated afterwards. For hard copies distributed in production and laboratory areas, there must be clear rules for how these documents are released and later collected when a new version becomes available to ensure that only the most current version is followed.

As stated above, the goal of creating standard operating procedures is to familiarize new team members and re-train existing employees, if required with a certain process. But beyond this, effective SOPs demonstrate the commitment a company has towards educating its own team, meeting regulatory requirements, and maintaining production quality,