How to Develop Quality Unit Roles & Responsibilities SOP for Supplements

Reviewed and Approved by Shelly Blackwell, Senior Director, Dietary Supplement and Tobacco, EAS Consulting Group 

1-Minute Summary 

• 21 CFR 111 requires written procedures for Quality Control (also know as Quality Unit – QU) operations in dietary supplement manufacturing. 
• Your QU Roles and Responsibilities SOP functions as an overarching document that defines the Quality Unit’s overall responsibilities; use additional SOPs to define specific processes and procedures. 
• Include sections like Purpose, Scope, Definitions, Responsibilities, and Procedures in your Quality Unit Roles and Responsibilities SOP. 
• Regularly review and update SOPs and maintain strong communication between the Quality Unit and Operations. 
   

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21 CFR 111 and SOP Requirements

Under 21 CFR 111.103, companies that manufacture, package, label, or hold dietary supplements are required to “…establish and follow written procedures for the responsibilities of the quality control operations.”  

One fundamental document that your organization should develop to fulfill this requirement is a Quality Unit Roles and Responsibilities standard operating procedure (SOP). It serves as a foundational document upon which all your other Quality System SOPs should be built.  

In this article, we provide tips for how to develop your QU Roles and Responsibilities SOP.  

What Your QU Roles and Responsibilities SOP Should – and Shouldn’t – Do  

Let’s start with a quick review of some applicable requirements in 21 CFR 111. The regulations list several requirements where procedures are required to help ensure the safety and quality of your supplements, including, at a minimum, the following: 

• Fulfilling requirements in Subpart B (Personnel) 
• Sanitation procedures  
• Cleaning the physical plant 
• Pest control 
• Calibration (instruments, controls, automated, mechanical, and electronic equipment) 
• Inspecting and checking automated, mechanical, and electronic equipment 
• Maintaining, cleaning, and sanitizing equipment and parts 
• Responsibilities of Quality Control  
• Material review and disposition 
• Reprocessing 
• Fulfilling requirements of Subpart G (requirements for components, packaging, labels, and products you receive) 
• Ensuring specifications are met as part of the MBR 
• Sampling 
• Laboratory operations 
• Specification creation  
• Tests to ensure specifications are met 
• Manufacturing operations, including deviations  
• Packaging and labeling operations 
• Sanitary handling/gowning 
• Holding and distributing 
• Returns 
• Complaints 
• Records management  

All of these procedures require some level of Quality Unit oversight. While your team needs to write SOPs for each of these processes, you also need one foundational SOP that defines the responsibilities of the Quality Unit as a whole. This is where your QU Roles and Responsibilities SOP comes in.  

Whereas individual operational SOPs provide specific details regarding each of the systems listed above, the QU Roles and Responsibilities SOP ties everything together.  

To use an analogy, your QU Roles and Responsibilities SOP is the entire house and the individual SOPs are rooms inside of it.   

What’s Included in a Quality Unit Roles and Responsibilities SOP? 

Now, let’s look at the kind of information to put in your QU Roles and Responsibilities SOP.  

Here are examples of sections to include along with explanations. This is not an exhaustive list but provides a good starting point: 

Purpose: Begin with a short, direct statement that defines the purpose of the SOP. For example, “The purpose of this SOP is to define the responsibilities of the [Company Name] Quality Unit as they pertain to compliance with applicable regulatory requirements, including 21 CFR 111.” 

Scope: Next, define the scope of the document by asking yourself, “To whom and to what does this document apply”? For example, does it apply only to your organization’s Quality Unit, or does it also apply to any of your business partners, such as a contract manufacturer if you are a Private Label Distributor (PLD)?  

Definitions: Define key terms, specific to your organization or others of importance.  

Responsibility: Define which job titles in your organization are responsible for the specific aspects of your Quality Unit, as applicable.  

Procedures: This section will include the bulk of the content. Using 21 CFR 111 as your guide, list the overall responsibilities of the Quality Unit as they relate to each regulatory requirement. It’s not necessary to list specific job functions; instead, simply define the responsibilities of the QU as a whole. Use direct language and number each line of the SOP for easy reference.  

Let’s look at an example using the requirements in 21 CFR 111.70 to establish specifications. This section of the SOP might look like this: 

The SOP makes it clear that your QU is responsible for developing all cGMP-related documents, including product specifications, without going into detail about how to carry out the task – that’s the job of your individual operational SOPs. 

Continue in this manner for all the responsibilities mandated in the regulations, including Master Manufacturing Records, Batch Production Records, expiration dates, supplier qualification, etc.  

The main point is to ensure all responsibilities in 21 CFR 111 are included in your SOP. Review the regulations carefully and enlist the help of a regulatory consultant, such as our team at EAS Consulting Group, if you need help developing your SOPs. Also, ensure your supporting SOPs are aligned with the overall Quality Unit Responsibility SOP. 

Best Practices When Writing Your SOPs 

• Keep your Quality Unit Roles and Responsibilities SOP concise and direct.  
• Operational SOPs for specific systems required in 21 CFR Part 111, such as sampling or pest control, can be longer since they may include images or flow charts to help ensure that personnel follow procedures exactly.  
• Avoid simply copying and pasting the requirements in 21 CFR 111 into your SOP; while your SOP must be compliant with the regulations, it also must be tailored to your organization’s processes and personnel.  
• One of the most common FDA observations is that you’re not following your own procedures, and writing your SOPs to fit your organization will help ensure they are followed.  
• Continually review and update your SOPs. Periodically ensure they are still applicable and nothing has changed.  
• Communication between Operations and the Quality Unit is key. Your teams must have open communication and a good relationship to ensure you have the information needed to develop effective SOPs.  
• During an inspection, the FDA will always ask to see where the Quality Unit responsibilities are documented. Having them defined in one SOP makes providing that information much easier to communicate.  
• Mention in your SOPs that qualified individuals are required for Quality Unit roles and support this requirement with the CVs or resumes aligned with the job descriptions for the individual filling that role. 

Seek Guidance When You Have Questions 

Your primary goal is always to produce safe, high-quality products that protect consumers and your brand. Effective SOPs and defined Quality Unit responsibilities support this goal. When you need guidance, contact our team at EAS Consulting Group to help answer your questions about your SOPs.