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.
A well-crafted SOP offers clear direction and instruction specifically designed to avoid deviations—an absolute necessity for maintaining compliance and delivering quality products.
The Basic Components of an Effective SOP
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.
Free White Paper: The Emergency Guide to FDA 483 & Warning Letters
With this goal in mind, here are a few best practices for writing SOPs based around common problems.
Writing procedures from the end user's perspective
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.
- 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.
- 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.
- 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.
- 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.
- 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.
A Model Format for an Effective SOP
The model described below lays out the components of an SOP in a way companies can adapt to their own needs and situations.
- Header: This should include the title, document number and version. The header should clearly identify the activity in question and contain any relevant keywords.
- (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.
- (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.
- (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.
- (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
- (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.
- (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.
- Major steps: Your SOP should include only the steps necessary for accomplishing the objective of the procedure.
- Individual action steps within each major step
- Notes: These should be provided separately and be given to offer information for clarifying the process and/or responsibilities and possible warnings.
- (7.0) Appendices: These typically work best as a flow chart to aid in explaining the procedures during and audit or for those who learn better visually.
- (8.0) Revision History: Record the changes made to a procedure and justification or the reason why the procedure was created.
- 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.”
Advice for SOP Distribution and Comprehension
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.
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.
"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.
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.