When Standard Operating Procedures Aren’t Enough

Although the FDA sometimes has a reputation as a stickler, it’s clear that the Food and Drug Administration often demonstrates a lot of patience, too—except when a company refuses to update their operating procedures to make required fixes to bring their standard operating procedures.

Listen: we get it. No one likes to hear phrases like “Standard Operating Procedures.” And no one wakes up in the morning wondering how clean and “standard” they can be that day. It’s just not exciting.

But it sure beats the alternative.

There was a good demonstration of exactly this recently when the FDA issued a warning letter to Apotheca Supply, Inc. dba Apothecares in Alabama. In addition to citing some identified problems with the standard operating procedure of Apotheca Supply, the FDA also mentioned that a 2015 response from the company failed to note sufficient corrections to these problems in the past.

The result? The FDA, as a food and drug administration has the right to be, is a stickler when it comes to peoples’ health. But according to this warning letter, Apotheca Supply has not done enough to conform to the FDA’s requirements despite being alerted to problems in the past. Now Apotheca Supply is to “conduct a risk assessment and provide us with a summary of the risks your deviations posed to the quality of your API. conduct a risk assessment and provide us with a summary of the risks your deviations posed to the quality of your API.” The FDA later notes, “Also, provide adequate justification for your risk assessment. … Additionally, provide an organizational chart that specifies the personnel authorized to release API and provide evidence that quality unit personnel are adequately trained in current good manufacturing practice.”

Needless to say, it’s apparent that the FDA’s hammer is dropping here. But we can take a closer look at this interaction and see what exactly it was that caused the FDA to take such a thorough look at this company. We’ll also examine what you can do to ensure that your own Standard Operating Procedures are up to snuff so you can create the safest and cleanest environment possible within your own enterprise. At the end of this article you’ll find our Technical Brief for auditing your own standard operating procedures.

Bad Standard Operating Procedures: Failing to Pass the Basics

The problem starts when the FDA discovers that your company doesn’t have the standard operating procedure to meet federal standards. As Pharmtech.com notes, “The FDA inspection also found the company failed to ensure the cleanliness of the facility and equipment. Investigators observed expired cleaning products and operators using cleaning agents not documented in cleaning procedures. The company also failed to perform cleaning validation studies.”

When a company is unable to get these standard operating procedures (SOPs) down pat, it often raises alarms for the FDA. Realistically, anyone working in the pharmaceutical or medical industry should know this—call it “cGMP 101.”

According to the letter issued by the FDA, the following problems were identified:

• The main responsibilities of each unit “were not described in writing,” which resulted in insufficient quality-related documents provided to the FDA.
• There was not enough stability data “to support the extension of expiration dates.” With extending the manufacturers’ expiration dates by “as much as two years,” this lead to significant problems.
• The firm “failed to ensure the cleanliness of [its] facility and equipment.” Additionally, the FDA found that there had not been documentation to ensure the quality of the current cleaning procedures in place.

Needless to say, most of these problems could have been fixed with the proper SOPs in place—approved by the quality unit, of course.

The FDA asked for a letter outlining the “specific steps” that will be taken to correct these problems within just 15 days. As is usually the case, the FDA kept its option to re-inspect the facilities after the steps are implemented.

If you see anything on this list that might ring a little uncomfortable with your own facilities, it might be time to update your standard operating procedures—before you get a letter from the FDA.

Download our Technical Brief on Standard Operating Procedures