The approval of new and generic drugs and biologics requires compliance with the Food and Drug Administration (FDA) requirements, which are among the highest standards across the globe. Before approval, the manufacturer must that the product is high quality, safe and effective. To help with the approval of drugs being sold in the United States the FDA tests selected drugs in the FDA laboratories. Post-market surveillance testing is one of the most proficient ways that the FDA helps ensure drugs sold on the market are of high quality, effective, and safe1.

Manufacturers all over the country are held accountable for the quality of products that reach the market. The FDA provides heavy oversight to manufacturers to ensure that they comply with regulations and jumps in when appropriate. The testing of active ingredients and finished drug products are also heavily tested each year, the majority of tested drug products are based on certain criteria.

The drug manufacturing process may trigger concerns and intricate FDA testing and monitoring. The FDA monitors drugs for faulty manufacturing processes and inaccurate shelf life to ensure each dosage will perform as intended. Drug sampling is also analyzed to verify that each precise dosage does not have deviation that may lead to quality concerns over time. There are various reasons a product may be required for the FDA testing program, a few examples include newly approved, first-time generic prescription drugs, most prescribed drugs, and drugs considered critical to counter-terrorism attacks1.

The FDA tests drugs to the standard that has been set by the U.S Pharmacopeia (An organization that sets the standards for identifying the strength, purity, and quality of manufactured medicines consumed worldwide), known as the monograph standards of identity, impurities, assay, and dissolution1. If a drug does not pass the USP monograph, the FDA will test it according to the methods developed and approved by the FDA for the original drug application.

The large majority of the tested drugs follow the specifications, however when a drug has unfavorable test outcomes they work to eliminate harm and inform the manufacturer that further actions must be taken to improve the drug products. Fortunately, EMMA International provides Full Circle Consulting services, give us a call at 248-987-4497 or email us at info@emmainternational.com to get in touch with our team of experts today.

[1] FDA (February 2020) Drug Quality Sampling and Testing Programs, Retrieved 03/27/2022 from https://www.fda.gov/drugs/science-and-research-drugs/drug-quality-sampling-and-testing-programs

Sarah Koehler

Sarah Koehler

Sarah is a Quality Engineer at EMMA International. She has experience in quality assurance, change management, laboratory controls, and process/equipment validation within the pharmaceutical and medical device industry. Sarah has earned a Bachelor of Science in Chemical Engineering from Western Michigan University.

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