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FDA Warning: Don’t Get Caught With Bad SOPs



Warnings letters stink, as they can impact a company’s image, stock value, and much more. That’s why companies should do everything in their power to make sure they follow FDA regulations to a “T.” 

Just last month, the FDA issued a pharmaceutical company a Form 483 for the “failure to develop adequate written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences from all sources as required by 21 CFR 314.80(b)” and the “failure to report each adverse drug experience not reported under 21 CFR 314.80(c)(1)(i) at quarterly intervals as required by 21 CFR 314.80(c)(2)(i).”

According to the letter, the company’s Standard Operating Procedures (SOPs) lacked a significant amount of detail regarding how the company collects, evaluates, and documents the adverse event information it receives.

This warning letter points to several inadequacies. For example, it’s not enough for SOPs to simply indicate that product complaints need to be logged by someone on your Quality Assurance team for investigation and that cases have to be entered in your pharmacovigilance database.

What’s missing, you ask? Who at your firm is responsible for retrieving reports forwarded to your company from a call center? How do they retrieve the reports? How does your staff ensure that all adverse event information obtained by the call center was forwarded and received? How does your staff ensure any adverse events obtained by the Quality Assurance team during a complaint investigation are forwarded to pharmacovigilance staff?

It’s absolutely true that drug safety and pharmacovigilance systems can help streamline case processing and reporting to regulatory authorities, such as the FDA or EMA. But equally as important are the SOPs that go along with them, which help ensure all systems and processes are followed.

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Eugene Sefanov

Director, Industry and Regional Marketing

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